## Protocol Section
### Identification Module
**NCT ID:** NCT03235479

**Brief Title:** Safety and Efficacy Study in Adult Subjects With Acute Migraines

**Official Title:** BHV3000-301: Phase 3: Double-Blind, Randomized, Placebo-Controlled, Safety and Efficacy Trial of BHV-3000 (Rimegepant) for the Acute Treatment of Migraine

#### Organization Study ID Info
**ID:** BHV-3000-301
#### Organization
**Class:** INDUSTRY
**Full Name:** Pfizer
### Status Module
#### Completion Date
**Date:** 2018-01-26

**Type:** ACTUAL

#### Disp First Post Date
**Date:** 2019-01-11

**Type:** ACTUAL

**Disp First Submit Date:** 2019-01-09
**Disp First Submit QC Date:** 2019-01-09

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-02-16

**Type:** ACTUAL

**Last Update Submit Date:** 2023-02-14

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2018-01-21

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2020-12-23

**Type:** ACTUAL

**Results First Submit Date:** 2020-11-30

**Results First Submit QC Date:** 2020-11-30

#### Start Date
**Date:** 2017-07-18

**Type:** ACTUAL

**Status Verified Date:** 2023-02

#### Study First Post Date
**Date:** 2017-08-01
**Type:** ACTUAL
**Study First Submit Date:** 2017-07-14
**Study First Submit QC Date:** 2017-07-27
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Pfizer

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** True

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The purpose of this study is to compare the efficacy of BHV-3000 (rimegepant) versus placebo in subjects with Acute Migraines

### Conditions Module

**Conditions:**

- Migraine, With or Without Aura

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** Randomized Controlled Trial

##### Masking Info

**Masking:** TRIPLE

**Masking Description:** Double-blind to Sponsor, Investigator and Participant

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 1485

**Type:** ACTUAL

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Participants were administered a single oral dose of 75 mg of rimegepant tablet on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.

**Intervention Names:**

- Drug: Rimegepant

**Label:** Rimegepant 75 mg

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Participants were administered a single oral dose of matching placebo tablet for rimegepant (75 mg) on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.

**Intervention Names:**

- Drug: Placebo

**Label:** Placebo

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Rimegepant 75 mg

**Description:** 75 mg tablet QD

**Name:** Rimegepant

**Other Names:**

- BHV-3000

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Placebo

**Description:** Placebo tablet to match rimegepant dose QD

**Name:** Placebo

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the electronic diary (eDiary). Pain freedom was defined as pain level of none.

**Measure:** Percentage of Participants With Freedom From Pain at 2 Hours Post-dose

**Time Frame:** 2 hours post-dose

**Description:** MBS was reported as nausea, photophobia, or phonophobia at migraine onset using the eDiary. Symptom status (absent, present) was assessed post-dose using the eDiary separately for nausea, photophobia, and phonophobia. Freedom from MBS was defined as MBS reported at onset that was absent post-dose.

**Measure:** Percentage of Participants With Freedom From Most Bothersome Symptom (MBS) at 2 Hours Post-dose

**Time Frame:** 2 hours post-dose

#### Secondary Outcomes

**Description:** Photophobia (sensitivity to light) status was measured as absent or present in the eDiary. Freedom from photophobia was defined as photophobia absent.

**Measure:** Percentage of Participants With Freedom From Photophobia at 2 Hours Post-dose

**Time Frame:** 2 hours post-dose

**Description:** Phonophobia (sensitivity to sound) status was measured as absent or present in the eDiary. Freedom from phonophobia was defined as phonophobia absent.

**Measure:** Percentage of Participants With Freedom From Phonophobia at 2 Hours Post-dose

**Time Frame:** 2 hours post-dose

**Description:** Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the eDiary. Pain relief was defined as pain level of none or mild.

**Measure:** Percentage of Participants With Pain Relief at 2 Hours Post-dose

**Time Frame:** 2 hours post-dose

**Description:** Nausea status was measured as absent or present in the eDiary. Freedom from nausea was defined as nausea absent.

**Measure:** Percentage of Participants With Freedom From Nausea at 2 Hours Post-dose

**Time Frame:** 2 hours post-dose

**Description:** Participants who did not experience relief of their migraine headache at the end of 2 hours after dosing with study medication (and after the 2-hour assessments had been completed on the eDiary) were permitted to use the following rescue medications: aspirin, ibuprofen, acetaminophen up to 1000 mg/day (this includes Excedrin Migraine), naproxen (or any other type of nonsteroidal anti-inflammatory drug), antiemetics (e.g., metoclopramide or promethazine), or baclofen. The participant's use of rescue medication was recorded by the participant in a paper diary.

**Measure:** Percentage of Participants With Rescue Medication Use Within 24 Hours Post-dose

**Time Frame:** 24 hours post-dose

**Description:** Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the eDiary. Sustained pain freedom was defined as pain level of none at 2 hours up to 24 hours post-dose with no rescue medication use through 24 hours post-dose.

**Measure:** Percentage of Participants With Sustained Pain Freedom From 2 to 24 Hours Post-dose

**Time Frame:** From 2 hours up to 24 hours post-dose

**Description:** Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the eDiary. Sustained pain relief was defined as pain level of none or mild at 2 hours up to 24 hours post-dose with no rescue medication use through 24 hours post-dose.

**Measure:** Percentage of Participants With Sustained Pain Relief From 2 to 24 Hours Post-dose

**Time Frame:** From 2 hours up to 24 hours post-dose

**Description:** Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the eDiary. Sustained pain freedom was defined as pain level of none at 2 hours up to 48 hours post-dose with no rescue medication use through 48 hours post-dose.

**Measure:** Percentage of Participants With Sustained Pain Freedom From 2 to 48 Hours Post-dose

**Time Frame:** From 2 hours up to 48 hours post-dose

**Description:** Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the eDiary. Sustained pain relief was defined as pain level of none or mild at 2 hours up to 48 hours post-dose with no rescue medication use through 48 hours post-dose.

**Measure:** Percentage of Participants With Sustained Pain Relief From 2 to 48 Hours Post-dose

**Time Frame:** From 2 hours up to 48 hours post-dose

**Description:** Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the eDiary. Pain relapse was defined as pain level of mild, moderate, or severe after 2 hours up to 48 hours for the participants who were pain-free at 2 hours post-dose.

**Measure:** Percentage of Participants With Pain Relapse From 2 to 48 Hours Post-dose

**Time Frame:** From 2 hours up to 48 hours post-dose

**Description:** Functional disability level was assessed in the eDiary on a 4-point scale: normal function, mild impairment, severe impairment, required bed rest. Freedom from functional disability was defined as normal function.

**Measure:** Percentage of Participants With Freedom From Functional Disability at 2 Hours Post-dose

**Time Frame:** 2 hours post-dose

### Eligibility Module

**Eligibility Criteria:** Key Inclusion Criteria:

1. Patient has at least 1 year history of migraines (with or without aura), consistent with a diagnosis according to the International Classification of Headache Disorder, 3rd Edition, Beta version\[1\] including the following:

   * Not more than 8 attacks of moderate or severe intensity per month within last 3 months
   * Consistent migraine headaches of at least 2 migraine headache attacks of moderate or severe intensity in each of the 3 months prior to the Screening Visit and maintains this requirement during the Screening Period
2. Less than 15 days with headache (migraine or non-migraine) per month in each of the 3 months prior to the Screening Visit and maintains this requirement during the Screening Period
3. Patients on prophylactic migraine medication are permitted to remain on therapy provided they have been on a stable dose for at least 3 months prior to study entry.
4. Patients with contraindications for use of triptans may be included provided they meet all other study entry criteria.

Key Exclusion Criteria:

1. Patient history of HIV disease
2. Patient history with current evidence of uncontrolled, unstable or recently diagnosed cardiovascular disease, such as ischemic heart disease, coronary artery vasospasm, and cerebral ischemia. Patients with Myocardial Infarction (MI), Acute Coronary Syndrome (ACS),Percutaneous Coronary Intervention (PCI), cardiac surgery, stroke or transient ischemic attack (TIA) during the 6 months prior to screening.
3. Uncontrolled hypertension (high blood pressure), or uncontrolled diabetes (however patients can be included who have stable hypertension and/or diabetes for 3 months prior to being enrolled)
4. Patient has a current diagnosis of major depression, other pain syndromes, psychiatric conditions (eg, schizophrenia), dementia, or significant neurological disorders (other than migraine) that, in the Investigator's opinion, might interfere with study assessments
5. Patient has a history of gastric, or small intestinal surgery, or has a disease that causes mal-absorption
6. The patient has a history or current evidence of any significant and/or unstable medical conditions (eg, history of congenital heart disease or arrhythmia, known suspected infection, hepatitis B or C, or cancer) that, in the investigator's opinion, would expose them to undue risk of a significant adverse event (AE) or interfere with assessments of safety or efficacy during the course of the trial
7. History of, treatment for, or evidence of, alcohol or drug abuse within the past 12 months or patients who have met DSM-V criteria for any significant substance use disorder within the past 12 months from the date of the screening visit.

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Birmingham

**Country:** United States

**Facility:** Central Research Associates, Inc

**State:** Alabama

**Zip:** 35205

**Location 2:**

**City:** Gilbert

**Country:** United States

**Facility:** Neurological Physicians of Arizona/Radiant Research Inc

**State:** Arizona

**Zip:** 85282

**Location 3:**

**City:** Tempe

**Country:** United States

**Facility:** Clinical Research Consortium Arizona

**State:** Arizona

**Zip:** 85283

**Location 4:**

**City:** Tucson

**Country:** United States

**Facility:** Radiant Research, Inc.

**State:** Arizona

**Zip:** 85712

**Location 5:**

**City:** Little Rock

**Country:** United States

**Facility:** Woodland International Research Group, LLC

**State:** Arkansas

**Zip:** 72211

**Location 6:**

**City:** Encino

**Country:** United States

**Facility:** Pharmacology Research Institute

**State:** California

**Zip:** 91316

**Location 7:**

**City:** San Francisco

**Country:** United States

**Facility:** Optimus Medical Group

**State:** California

**Zip:** 94102

**Location 8:**

**City:** Santa Monica

**Country:** United States

**Facility:** California Medical Clinic for Headache

**State:** California

**Zip:** 90404

**Location 9:**

**City:** Walnut Creek

**Country:** United States

**Facility:** Diablo Clinical Research, Inc

**State:** California

**Zip:** 94598

**Location 10:**

**City:** Hollywood

**Country:** United States

**Facility:** Qps Mra, Llc

**State:** Florida

**Zip:** 33024

**Location 11:**

**City:** Lake City

**Country:** United States

**Facility:** Multi-Specialty Research Associates, Inc

**State:** Florida

**Zip:** 32055

**Location 12:**

**City:** Miami

**Country:** United States

**Facility:** Qps Mra, Llc

**State:** Florida

**Zip:** 33143

**Location 13:**

**City:** Miami

**Country:** United States

**Facility:** Advanced Pharma CR, LLC

**State:** Florida

**Zip:** 33147

**Location 14:**

**City:** Orlando

**Country:** United States

**Facility:** Compass Research, LLC

**State:** Florida

**Zip:** 32806

**Location 15:**

**City:** Ormond Beach

**Country:** United States

**Facility:** Ormond Medical Arts Pharmaceutical Research

**State:** Florida

**Zip:** 32174

**Location 16:**

**City:** Savannah

**Country:** United States

**Facility:** Meridian Clinical Research

**State:** Georgia

**Zip:** 31406

**Location 17:**

**City:** New Orleans

**Country:** United States

**Facility:** New Orleans Center for Clinical Research

**State:** Louisiana

**Zip:** 70119

**Location 18:**

**City:** Boston

**Country:** United States

**Facility:** Boston Clinical Trials, Inc

**State:** Massachusetts

**Zip:** 02131

**Location 19:**

**City:** Marlborough

**Country:** United States

**Facility:** Milford Emergency Associates, Inc.

**State:** Massachusetts

**Zip:** 01752

**Location 20:**

**City:** Ann Arbor

**Country:** United States

**Facility:** Michigan Head Pain & Neurological Institute

**State:** Michigan

**Zip:** 48104

**Location 21:**

**City:** Minneapolis

**Country:** United States

**Facility:** Clinical Research Institute, Inc

**State:** Minnesota

**Zip:** 55402

**Location 22:**

**City:** Minneapolis

**Country:** United States

**Facility:** Clinical Research Institute

**State:** Minnesota

**Zip:** 55402

**Location 23:**

**City:** Kansas City

**Country:** United States

**Facility:** The Center for Pharmaceutical Research

**State:** Missouri

**Zip:** 64114

**Location 24:**

**City:** Saint Louis

**Country:** United States

**Facility:** Sundance Clinical Research, LLC

**State:** Missouri

**Zip:** 63141

**Location 25:**

**City:** Norfolk

**Country:** United States

**Facility:** Meridian Clinical Research -Norfolk

**State:** Nebraska

**Zip:** 68701

**Location 26:**

**City:** Omaha

**Country:** United States

**Facility:** Meridian Clinical Research, LLC

**State:** Nebraska

**Zip:** 68134

**Location 27:**

**City:** Las Vegas

**Country:** United States

**Facility:** Clinical Research Consortium- Las Vegas

**State:** Nevada

**Zip:** 89119

**Location 28:**

**City:** Berlin

**Country:** United States

**Facility:** Hassman Research Institute, LLC

**State:** New Jersey

**Zip:** 08009

**Location 29:**

**City:** Brooklyn

**Country:** United States

**Facility:** SPRI Clinical Trials, LLC

**State:** New York

**Zip:** 11235

**Location 30:**

**City:** Endwell

**Country:** United States

**Facility:** Regional Clinical Research, Inc.

**State:** New York

**Zip:** 13760

**Location 31:**

**City:** Manlius

**Country:** United States

**Facility:** Central New York Clinical Research

**State:** New York

**Zip:** 13104

**Location 32:**

**City:** New York

**Country:** United States

**Facility:** Fieve Clinical Research

**State:** New York

**Zip:** 10168

**Location 33:**

**City:** Rochester

**Country:** United States

**Facility:** Rochester Clinical Research, Inc

**State:** New York

**Zip:** 14609

**Location 34:**

**City:** Greensboro

**Country:** United States

**Facility:** PharmQuest, LLC

**State:** North Carolina

**Zip:** 27408

**Location 35:**

**City:** Cincinnati

**Country:** United States

**Facility:** CTI Clinical Research Center

**State:** Ohio

**Zip:** 45227

**Location 36:**

**City:** Portland

**Country:** United States

**Facility:** Oregon Center for Clinical Investigations, Inc

**State:** Oregon

**Zip:** 97214

**Location 37:**

**City:** Philadelphia

**Country:** United States

**Facility:** Clinical Research of Philadelphia, LLC

**State:** Pennsylvania

**Zip:** 19114-1029

**Location 38:**

**City:** Uniontown

**Country:** United States

**Facility:** Preferred Primary Care Physicians

**State:** Pennsylvania

**Zip:** 15401

**Location 39:**

**City:** Warwick

**Country:** United States

**Facility:** Omega Medical Research

**State:** Rhode Island

**Zip:** 02886

**Location 40:**

**City:** Mount Pleasant

**Country:** United States

**Facility:** Coastal Carolina Research Center

**State:** South Carolina

**Zip:** 29464

**Location 41:**

**City:** Dakota Dunes

**Country:** United States

**Facility:** Meridian Clinical Research

**State:** South Dakota

**Zip:** 57409

**Location 42:**

**City:** Austin

**Country:** United States

**Facility:** FutureSearch Trials of Neurology, LP

**State:** Texas

**Zip:** 78731

**Location 43:**

**City:** Dallas

**Country:** United States

**Facility:** FutureSearch Trials of Neurology, LP

**State:** Texas

**Zip:** 75231

**Location 44:**

**City:** Houston

**Country:** United States

**Facility:** Texas Center for Drug Development

**State:** Texas

**Zip:** 77081

**Location 45:**

**City:** Salt Lake City

**Country:** United States

**Facility:** J.Lewis Research Inc / Foothill Family Clinic South

**State:** Utah

**Zip:** 84121

**Location 46:**

**City:** South Jordan

**Country:** United States

**Facility:** J.Lewis Research Inc. / Jordan River Family Med

**State:** Utah

**Zip:** 84095

**Location 47:**

**City:** Norfolk

**Country:** United States

**Facility:** Clinical Research Associates of Tidewater, Inc.

**State:** Virginia

**Zip:** 23507

**Location 48:**

**City:** Virginia Beach

**Country:** United States

**Facility:** Tidewater Integrated Medical Research

**State:** Virginia

**Zip:** 23454

**Location 49:**

**City:** Bellevue

**Country:** United States

**Facility:** Northwest Clinical Research Center

**State:** Washington

**Zip:** 98007

**Location 50:**

**City:** Seattle

**Country:** United States

**Facility:** Seattle Women's:Health, Research & Gynecology

**State:** Washington

**Zip:** 98105

## Document Section

### Large Document Module

#### Large Docs

- Date: 2018-01-23

- Filename: Prot_000.pdf

- Has ICF: False

- Has Protocol: True

- Has SAP: False

- Label: Study Protocol

- Size: 2402887

- Type Abbrev: Prot

- Upload Date: 2020-11-25T01:19

- Date: 2018-06-20

- Filename: SAP_001.pdf

- Has ICF: False

- Has Protocol: False

- Has SAP: True

- Label: Statistical Analysis Plan

- Size: 6275241

- Type Abbrev: SAP

- Upload Date: 2020-11-25T01:20

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000051270

- Term: Headache Disorders, Primary

- ID: D000020773

- Term: Headache Disorders

- ID: D000001927

- Term: Brain Diseases

- ID: D000002493

- Term: Central Nervous System Diseases

- ID: D000009422

- Term: Nervous System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M11852

- Name: Migraine Disorders

- Relevance: HIGH

- As Found: Migraine

- ID: M9351

- Name: Headache

- Relevance: LOW

- As Found: Unknown

- ID: M22529

- Name: Headache Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M26657

- Name: Headache Disorders, Primary

- Relevance: LOW

- As Found: Unknown

- ID: M5204

- Name: Brain Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5742

- Name: Central Nervous System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T170

- Name: Acute Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000008881

- Term: Migraine Disorders

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

**Description:** The safety population, all enrolled participants who received at least 1 dose of rimegepant or placebo, was used to determine the number of participants at risk for SAEs and other AEs.

#### Event Groups

**Group ID:** EG000

**Title:** Rimegepant 75 mg

**Deaths Num At Risk:** 546

**Description:** Participants were administered a single oral dose of 75 mg of rimegepant on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.

**ID:** EG000

**Other Num at Risk:** 546

**Serious Number Affected:** 2

**Serious Number At Risk:** 546

**Title:** Rimegepant 75 mg

**Group ID:** EG001

**Title:** Placebo

**Deaths Num At Risk:** 549

**Description:** Participants were administered a single oral dose of matching placebo for rimegepant (75 mg) on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.

**ID:** EG001

**Other Num at Risk:** 549

**Serious Number Affected:** 1

**Serious Number At Risk:** 549

**Title:** Placebo

**Frequency Threshold:** 5

#### Serious Events

**Term:** Acute Respiratory Failure

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA 20.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 546

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 549

**Term:** Pulmonary Embolism

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA 20.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 546

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 549

**Term:** Colitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 546

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 549

**Num Events:** 1

**Time Frame:** Serious adverse events (SAEs) were collected from informed consent up to the end of study, and adverse events (AEs) were collected from randomization up to the end of the study (up to 52 days).

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 543

**Group ID:** BG001

**Value:** 541

**Group ID:** BG002

**Value:** 1084

**Units:** Participants

### Group

**ID:** BG000

**Title:** Rimegepant 75 mg

**Description:** Participants were administered a single oral dose of 75 mg of rimegepant on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.

### Group

**ID:** BG001

**Title:** Placebo

**Description:** Participants were administered a single oral dose of matching placebo for rimegepant (75 mg) on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.

### Group

**ID:** BG002

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 12.3286

**Value:** 41.945

#### Measurement

**Group ID:** BG001

**Spread:** 12.1381

**Value:** 41.326

#### Measurement

**Group ID:** BG002

**Spread:** 12.2322

**Value:** 41.636

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 464

#### Measurement

**Group ID:** BG001

**Value:** 463

#### Measurement

**Group ID:** BG002

**Value:** 927

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 79

#### Measurement

**Group ID:** BG001

**Value:** 78

#### Measurement

**Group ID:** BG002

**Value:** 157

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 58

#### Measurement

**Group ID:** BG001

**Value:** 68

#### Measurement

**Group ID:** BG002

**Value:** 126

**Category Title:** Hispanic or Latino

#### Measurement

**Group ID:** BG000

**Value:** 485

#### Measurement

**Group ID:** BG001

**Value:** 473

#### Measurement

**Group ID:** BG002

**Value:** 958

**Category Title:** Not Hispanic or Latino

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** Unknown or Not Reported

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 1

#### Measurement

**Group ID:** BG001

**Value:** 3

#### Measurement

**Group ID:** BG002

**Value:** 4

**Category Title:** American Indian or Alaska Native

#### Measurement

**Group ID:** BG000

**Value:** 6

#### Measurement

**Group ID:** BG001

**Value:** 7

#### Measurement

**Group ID:** BG002

**Value:** 13

**Category Title:** Asian

#### Measurement

**Group ID:** BG000

**Value:** 2

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 2

**Category Title:** Native Hawaiian or Other Pacific Islander

#### Measurement

**Group ID:** BG000

**Value:** 107

#### Measurement

**Group ID:** BG001

**Value:** 80

#### Measurement

**Group ID:** BG002

**Value:** 187

**Category Title:** Black or African American

#### Measurement

**Group ID:** BG000

**Value:** 417

#### Measurement

**Group ID:** BG001

**Value:** 444

#### Measurement

**Group ID:** BG002

**Value:** 861

**Category Title:** White

#### Measurement

**Group ID:** BG000

**Value:** 10

#### Measurement

**Group ID:** BG001

**Value:** 7

#### Measurement

**Group ID:** BG002

**Value:** 17

**Category Title:** More than one race

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** Unknown or Not Reported

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 353

#### Measurement

**Group ID:** BG001

**Value:** 358

#### Measurement

**Group ID:** BG002

**Value:** 711

**Class Title:** Migraine without Aura

#### Measurement

**Group ID:** BG000

**Value:** 190

#### Measurement

**Group ID:** BG001

**Value:** 183

#### Measurement

**Group ID:** BG002

**Value:** 373

**Class Title:** Migraine with Aura

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 90

#### Measurement

**Group ID:** BG001

**Value:** 92

#### Measurement

**Group ID:** BG002

**Value:** 182

**Category Title:** Yes

#### Measurement

**Group ID:** BG000

**Value:** 453

#### Measurement

**Group ID:** BG001

**Value:** 449

#### Measurement

**Group ID:** BG002

**Value:** 902

**Category Title:** No

**Class Title:** 

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age, Continuous
**Unit of Measure:** years
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Ethnicity (NIH/OMB)
**Unit of Measure:** Participants
### Measure 4
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Race (NIH/OMB)
**Unit of Measure:** Participants
### Measure 5
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Primary Migraine Type
**Unit of Measure:** Participants
### Measure 6
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Randomization Strata, Prophylactic Migraine Medication Use
**Unit of Measure:** Participants
**Population Description:** The analysis was performed on modified intent to treat (mITT) participants, defined as those who were randomized only once, took study medication, had moderate to severe pain level at migraine onset, and who provided at least 1 post-dose efficacy measurement (i.e., after taking study medication).
## Results Section - More Information Module
### Certain Agreement
**Restriction Type:** LTE60
**Restrictive Agreement:** True
### Point of Contact
**Email:** clinicaltrials@biohavenpharma.com
**Organization:** Biohaven Pharmaceuticals, Inc.
**Phone:** 203-404-0410
**Title:** Chief Medical Officer
## Results Section - Outcome Measures Module
### Outcome Measure 1
#### Analysis
**CI Lower Limit:** 0.5
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 9.3
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.0298
**P-Value Comment:** 
**Parameter Type:** Risk Difference (RD)
**Parameter Value:** 4.9
**Statistical Comment:** 
**Statistical Method:** Cochran-Mantel-Haenszel
**Tested Non-Inferiority:** 
### Outcome Measure 2
#### Analysis
**CI Lower Limit:** 3.4
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 14.4
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.0016
**P-Value Comment:** 
**Parameter Type:** Risk Difference (RD)
**Parameter Value:** 8.9
**Statistical Comment:** 
**Statistical Method:** Cochran-Mantel-Haenszel
**Tested Non-Inferiority:** 
### Outcome Measure 3
#### Analysis
**CI Lower Limit:** 4.4
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 15.9
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.0005
**P-Value Comment:** 
**Parameter Type:** Risk Difference (RD)
**Parameter Value:** 10.2
**Statistical Comment:** 
**Statistical Method:** Cochran-Mantel-Haenszel
**Tested Non-Inferiority:** 
### Outcome Measure 4
#### Analysis
**CI Lower Limit:** 0.8
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 14.6
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.0299
**P-Value Comment:** 
**Parameter Type:** Risk Difference (RD)
**Parameter Value:** 7.7
**Statistical Comment:** 
**Statistical Method:** Cochran-Mantel-Haenszel
**Tested Non-Inferiority:** 
### Outcome Measure 5
#### Analysis
**CI Lower Limit:** 4.4
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 16.2
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.0006
**P-Value Comment:** 
**Parameter Type:** Risk Difference (RD)
**Parameter Value:** 10.3
**Statistical Comment:** 
**Statistical Method:** Cochran-Mantel-Haenszel
**Tested Non-Inferiority:** 
### Outcome Measure 6
#### Analysis
**CI Lower Limit:** -2.4
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 12.9
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.1815
**P-Value Comment:** P-value ≥ 0.05; therefore, all secondary outcome measures listed after this outcome measure in the hierarchy were not tested.
**Parameter Type:** Risk Difference (RD)
**Parameter Value:** 5.2
**Statistical Comment:** 
**Statistical Method:** Cochran-Mantel-Haenszel
**Tested Non-Inferiority:** 
### Outcome Measure 7
### Outcome Measure 8
### Outcome Measure 9
### Outcome Measure 10
### Outcome Measure 11
### Outcome Measure 12
### Outcome Measure 13
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 15.8
- **Spread:** 
- **Upper Limit:** 22.5
- **Value:** 19.2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 11.3
- **Spread:** 
- **Upper Limit:** 17.2
- **Value:** 14.2
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 32.6
- **Spread:** 
- **Upper Limit:** 40.7
- **Value:** 36.6
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 24.0
- **Spread:** 
- **Upper Limit:** 31.5
- **Value:** 27.7
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 30.6
- **Spread:** 
- **Upper Limit:** 39.2
- **Value:** 34.9
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 20.9
- **Spread:** 
- **Upper Limit:** 28.6
- **Value:** 24.8
**Title:** 
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 33.4
- **Spread:** 
- **Upper Limit:** 43.7
- **Value:** 38.6
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 26.2
- **Spread:** 
- **Upper Limit:** 35.5
- **Value:** 30.9
**Title:** 
#### Outcome Measure 5
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 51.8
- **Spread:** 
- **Upper Limit:** 60.2
- **Value:** 56.0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 41.5
- **Spread:** 
- **Upper Limit:** 49.9
- **Value:** 45.7
**Title:** 
#### Outcome Measure 6
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 41.4
- **Spread:** 
- **Upper Limit:** 52.3
- **Value:** 46.9
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 36.2
- **Spread:** 
- **Upper Limit:** 47.0
- **Value:** 41.6
**Title:** 
#### Outcome Measure 7
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 17.1
- **Spread:** 
- **Upper Limit:** 23.8
- **Value:** 20.4
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 27.9
- **Spread:** 
- **Upper Limit:** 35.6
- **Value:** 31.8
**Title:** 
#### Outcome Measure 8
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 11.1
- **Spread:** 
- **Upper Limit:** 16.9
- **Value:** 14.0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 5.8
- **Spread:** 
- **Upper Limit:** 10.4
- **Value:** 8.1
**Title:** 
#### Outcome Measure 9
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 34.8
- **Spread:** 
- **Upper Limit:** 43.0
- **Value:** 38.9
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 24.2
- **Spread:** 
- **Upper Limit:** 31.7
- **Value:** 27.9
**Title:** 
#### Outcome Measure 10
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 8.9
- **Spread:** 
- **Upper Limit:** 14.3
- **Value:** 11.6
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 5.0
- **Spread:** 
- **Upper Limit:** 9.4
- **Value:** 7.2
**Title:** 
#### Outcome Measure 11
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 29.7
- **Spread:** 
- **Upper Limit:** 37.7
- **Value:** 33.7
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 20.3
- **Spread:** 
- **Upper Limit:** 27.4
- **Value:** 23.9
**Title:** 
#### Outcome Measure 12
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 30.6
- **Spread:** 
- **Upper Limit:** 49.6
- **Value:** 40.1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 39.0
- **Spread:** 
- **Upper Limit:** 61.0
- **Value:** 50.0
**Title:** 
#### Outcome Measure 13
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 29.4
- **Spread:** 
- **Upper Limit:** 37.3
- **Value:** 33.3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 18.4
- **Spread:** 
- **Upper Limit:** 25.3
- **Value:** 21.8
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the electronic diary (eDiary). Pain freedom was defined as pain level of none.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** NUMBER
**Population Description:** The analysis was performed on modified intent to treat (mITT) participants.
**Reporting Status:** POSTED
**Time Frame:** 2 hours post-dose
**Title:** Percentage of Participants With Freedom From Pain at 2 Hours Post-dose
**Type:** PRIMARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** Participants were administered a single oral dose of 75 mg of rimegepant on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.
**ID:** OG000
**Title:** Rimegepant 75 mg
##### Group
**Description:** Participants were administered a single oral dose of matching placebo for rimegepant (75 mg) on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 2
**Description:** MBS was reported as nausea, photophobia, or phonophobia at migraine onset using the eDiary. Symptom status (absent, present) was assessed post-dose using the eDiary separately for nausea, photophobia, and phonophobia. Freedom from MBS was defined as MBS reported at onset that was absent post-dose.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** NUMBER
**Population Description:** The analysis was performed on mITT participants.
**Reporting Status:** POSTED
**Time Frame:** 2 hours post-dose
**Title:** Percentage of Participants With Freedom From Most Bothersome Symptom (MBS) at 2 Hours Post-dose
**Type:** PRIMARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** Participants were administered a single oral dose of 75 mg of rimegepant on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.
**ID:** OG000
**Title:** Rimegepant 75 mg
##### Group
**Description:** Participants were administered a single oral dose of matching placebo for rimegepant (75 mg) on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 3
**Description:** Photophobia (sensitivity to light) status was measured as absent or present in the eDiary. Freedom from photophobia was defined as photophobia absent.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** NUMBER
**Population Description:** The analysis was performed on mITT participants with photophobia present at migraine onset.
**Reporting Status:** POSTED
**Time Frame:** 2 hours post-dose
**Title:** Percentage of Participants With Freedom From Photophobia at 2 Hours Post-dose
**Type:** SECONDARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** Participants were administered a single oral dose of 75 mg of rimegepant on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.
**ID:** OG000
**Title:** Rimegepant 75 mg
##### Group
**Description:** Participants were administered a single oral dose of matching placebo for rimegepant (75 mg) on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 4
**Description:** Phonophobia (sensitivity to sound) status was measured as absent or present in the eDiary. Freedom from phonophobia was defined as phonophobia absent.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** NUMBER
**Population Description:** The analysis was performed on mITT participants with phonophobia present at migraine onset.
**Reporting Status:** POSTED
**Time Frame:** 2 hours post-dose
**Title:** Percentage of Participants With Freedom From Phonophobia at 2 Hours Post-dose
**Type:** SECONDARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** Participants were administered a single oral dose of 75 mg of rimegepant on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.
**ID:** OG000
**Title:** Rimegepant 75 mg
##### Group
**Description:** Participants were administered a single oral dose of matching placebo for rimegepant (75 mg) on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 5
**Description:** Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the eDiary. Pain relief was defined as pain level of none or mild.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** NUMBER
**Population Description:** The analysis was performed on mITT participants.
**Reporting Status:** POSTED
**Time Frame:** 2 hours post-dose
**Title:** Percentage of Participants With Pain Relief at 2 Hours Post-dose
**Type:** SECONDARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** Participants were administered a single oral dose of 75 mg of rimegepant on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.
**ID:** OG000
**Title:** Rimegepant 75 mg
##### Group
**Description:** Participants were administered a single oral dose of matching placebo for rimegepant (75 mg) on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 6
**Description:** Nausea status was measured as absent or present in the eDiary. Freedom from nausea was defined as nausea absent.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** NUMBER
**Population Description:** The analysis was performed on mITT participants with nausea present at migraine onset.
**Reporting Status:** POSTED
**Time Frame:** 2 hours post-dose
**Title:** Percentage of Participants With Freedom From Nausea at 2 Hours Post-dose
**Type:** SECONDARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** Participants were administered a single oral dose of 75 mg of rimegepant on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.
**ID:** OG000
**Title:** Rimegepant 75 mg
##### Group
**Description:** Participants were administered a single oral dose of matching placebo for rimegepant (75 mg) on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 7
**Description:** Participants who did not experience relief of their migraine headache at the end of 2 hours after dosing with study medication (and after the 2-hour assessments had been completed on the eDiary) were permitted to use the following rescue medications: aspirin, ibuprofen, acetaminophen up to 1000 mg/day (this includes Excedrin Migraine), naproxen (or any other type of nonsteroidal anti-inflammatory drug), antiemetics (e.g., metoclopramide or promethazine), or baclofen. The participant's use of rescue medication was recorded by the participant in a paper diary.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** NUMBER
**Population Description:** The analysis was performed on mITT participants.
**Reporting Status:** POSTED
**Time Frame:** 24 hours post-dose
**Title:** Percentage of Participants With Rescue Medication Use Within 24 Hours Post-dose
**Type:** SECONDARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** Participants were administered a single oral dose of 75 mg of rimegepant on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.
**ID:** OG000
**Title:** Rimegepant 75 mg
##### Group
**Description:** Participants were administered a single oral dose of matching placebo for rimegepant (75 mg) on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 8
**Description:** Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the eDiary. Sustained pain freedom was defined as pain level of none at 2 hours up to 24 hours post-dose with no rescue medication use through 24 hours post-dose.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** NUMBER
**Population Description:** The analysis was performed on mITT participants.
**Reporting Status:** POSTED
**Time Frame:** From 2 hours up to 24 hours post-dose
**Title:** Percentage of Participants With Sustained Pain Freedom From 2 to 24 Hours Post-dose
**Type:** SECONDARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** Participants were administered a single oral dose of 75 mg of rimegepant on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.
**ID:** OG000
**Title:** Rimegepant 75 mg
##### Group
**Description:** Participants were administered a single oral dose of matching placebo for rimegepant (75 mg) on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 9
**Description:** Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the eDiary. Sustained pain relief was defined as pain level of none or mild at 2 hours up to 24 hours post-dose with no rescue medication use through 24 hours post-dose.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** NUMBER
**Population Description:** The analysis was performed on mITT participants.
**Reporting Status:** POSTED
**Time Frame:** From 2 hours up to 24 hours post-dose
**Title:** Percentage of Participants With Sustained Pain Relief From 2 to 24 Hours Post-dose
**Type:** SECONDARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** Participants were administered a single oral dose of 75 mg of rimegepant on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.
**ID:** OG000
**Title:** Rimegepant 75 mg
##### Group
**Description:** Participants were administered a single oral dose of matching placebo for rimegepant (75 mg) on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 10
**Description:** Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the eDiary. Sustained pain freedom was defined as pain level of none at 2 hours up to 48 hours post-dose with no rescue medication use through 48 hours post-dose.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** NUMBER
**Population Description:** The analysis was performed on mITT participants.
**Reporting Status:** POSTED
**Time Frame:** From 2 hours up to 48 hours post-dose
**Title:** Percentage of Participants With Sustained Pain Freedom From 2 to 48 Hours Post-dose
**Type:** SECONDARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** Participants were administered a single oral dose of 75 mg of rimegepant on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.
**ID:** OG000
**Title:** Rimegepant 75 mg
##### Group
**Description:** Participants were administered a single oral dose of matching placebo for rimegepant (75 mg) on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 11
**Description:** Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the eDiary. Sustained pain relief was defined as pain level of none or mild at 2 hours up to 48 hours post-dose with no rescue medication use through 48 hours post-dose.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** NUMBER
**Population Description:** The analysis was performed on mITT participants.
**Reporting Status:** POSTED
**Time Frame:** From 2 hours up to 48 hours post-dose
**Title:** Percentage of Participants With Sustained Pain Relief From 2 to 48 Hours Post-dose
**Type:** SECONDARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** Participants were administered a single oral dose of 75 mg of rimegepant on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.
**ID:** OG000
**Title:** Rimegepant 75 mg
##### Group
**Description:** Participants were administered a single oral dose of matching placebo for rimegepant (75 mg) on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 12
**Description:** Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the eDiary. Pain relapse was defined as pain level of mild, moderate, or severe after 2 hours up to 48 hours for the participants who were pain-free at 2 hours post-dose.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** NUMBER
**Population Description:** The analysis population was performed on mITT participants with pain freedom at 2 hours post-dose.
**Reporting Status:** POSTED
**Time Frame:** From 2 hours up to 48 hours post-dose
**Title:** Percentage of Participants With Pain Relapse From 2 to 48 Hours Post-dose
**Type:** SECONDARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** Participants were administered a single oral dose of 75 mg of rimegepant on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.
**ID:** OG000
**Title:** Rimegepant 75 mg
##### Group
**Description:** Participants were administered a single oral dose of matching placebo for rimegepant (75 mg) on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 13
**Description:** Functional disability level was assessed in the eDiary on a 4-point scale: normal function, mild impairment, severe impairment, required bed rest. Freedom from functional disability was defined as normal function.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** NUMBER
**Population Description:** The analysis was performed on mITT participants.
**Reporting Status:** POSTED
**Time Frame:** 2 hours post-dose
**Title:** Percentage of Participants With Freedom From Functional Disability at 2 Hours Post-dose
**Type:** SECONDARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** Participants were administered a single oral dose of 75 mg of rimegepant on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.
**ID:** OG000
**Title:** Rimegepant 75 mg
##### Group
**Description:** Participants were administered a single oral dose of matching placebo for rimegepant (75 mg) on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.
**ID:** OG001
**Title:** Placebo
### Participant Flow Module
#### Group
**Description:** Participants were administered a single oral dose of 75 mg of rimegepant on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.
**ID:** FG000
**Title:** Rimegepant 75 mg
#### Group
**Description:** Participants were administered a single oral dose of matching placebo for rimegepant (75 mg) on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.
**ID:** FG001
**Title:** Placebo
#### Period
**Title:** Overall Study
##### Withdraw
**Type:** Lost to Follow-up
###### Reason
**Group ID:** FG000
**Number of Subjects:** 8
###### Reason
**Group ID:** FG001
**Number of Subjects:** 11
##### Withdraw
**Type:** Not Experienced Moderate/Severe Migraine
###### Reason
**Group ID:** FG000
**Number of Subjects:** 23
###### Reason
**Group ID:** FG001
**Number of Subjects:** 17
##### Withdraw
**Type:** Pregnancy
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
##### Withdraw
**Type:** Protocol Deviation
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 3
##### Withdraw
**Type:** Technical Problems
###### Reason
**Group ID:** FG000
**Number of Subjects:** 3
###### Reason
**Group ID:** FG001
**Number of Subjects:** 2
##### Withdraw
**Type:** Withdrawal by Subject
###### Reason
**Group ID:** FG000
**Number of Subjects:** 2
###### Reason
**Group ID:** FG001
**Number of Subjects:** 2
##### Withdraw
**Type:** Other Reasons
###### Reason
**Group ID:** FG000
**Number of Subjects:** 3
###### Reason
**Group ID:** FG001
**Number of Subjects:** 5
##### Milestone
**Type:** STARTED
**Comment:** Randomized
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 582
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 580
##### Milestone
**Type:** Treated
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 546
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 549
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 541
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 540
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 41
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 40
**Pre-Assignment Details:** A total of 1485 participants were enrolled, of which 1162 participants were randomized to BHV-3000 (rimegepant) 75 milligram (mg) or placebo. A total of 323 participants failed screening mainly due to failure to meet eligibility criteria.The randomization was stratified in a 1:1 ratio based on use of prophylactic migraine medications (yes or no).
**Recruitment Details:** The study was conducted at 50 centers in the United States.
**Has Results:** True