## Protocol Section
### Identification Module
**NCT ID:** NCT06417775

**Brief Title:** Study of Oral Ubrogepant to Assess Adverse Events and Change in Disease Activity in Adult Participants With Menstrual Migraine

**Official Title:** A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Ubrogepant for the Preventive Treatment of Menstrual Migraine With an Open-Label Extension

#### Organization Study ID Info
**ID:** M23-714
#### Organization
**Class:** INDUSTRY
**Full Name:** AbbVie
### Status Module
#### Completion Date
**Date:** 2027-09-08

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-16

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-13

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2027-09-08

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-29

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-13
**Study First Submit QC Date:** 2024-05-13
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** AbbVie

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** True

**Is US Export:** True

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** A migraine is a moderate to severe headache typically on one side of the head. A migraine attack is a headache that may be accompanied by throbbing, nausea, vomiting, sensitivity to light and sound, or other symptoms. Menstrual migraine (MM) is defined as migraine attacks that occur within the perimenstrual period (PMP) in at least 2 out of 3 menstrual cycles. The PMP is from 2 days before the onset of menstrual bleeding to 2 days after. This study will assess how safe and effective ubrogepant is in treating menstrual migraine. Adverse Events and change in disease activity will be assessed.

Ubrogepant is an investigational drug being developed for short-term prevention of menstrual migraine. Participants will be randomly assigned to one of the 2 groups to receive either ubrogepant or placebo. Around 450 adult female participants with menstrual migraine will be enrolled in approximately 85 sites in the United States and Puerto Rico.

Participants will receive oral ubrogepant tablets once daily for 7 consecutive days starting 3 days prior to estimated onset of menses per cycle for 3 PMPs during double-blind period (16 weeks). Eligible participants may continue to receive oral ubrogepant tablets once daily for 7 consecutive days per cycle starting 3 days prior to estimated onset of menses during open-label extension period (52 weeks).

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will collect data daily in electronic diaries and attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

### Conditions Module

**Conditions:**

- Migraine

**Keywords:**

- Migraine

- Menstrual Migraine

- Ubrogepant

- UBRELVY

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** SEQUENTIAL

##### Masking Info

**Masking:** QUADRUPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 450

**Type:** ESTIMATED

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Participants will receive ubrogepant during the double-blind period.

**Intervention Names:**

- Drug: Ubrogepant

**Label:** Double-Blind Period: Ubrogepant

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Participants will receive placebo during the double-blind period.

**Intervention Names:**

- Drug: Placebo for Ubrogepant

**Label:** Double-Blind Period: Placebo for Ubrogepant

**Type:** EXPERIMENTAL

#### Arm Group 3

**Description:** Eligible participants from Double-Blind period may continue to receive ubrogepant during the open-label extension period.

**Intervention Names:**

- Drug: Ubrogepant

**Label:** Open-Label Extension Period: Ubrogepant

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Double-Blind Period: Ubrogepant

- Open-Label Extension Period: Ubrogepant

**Description:** Oral Tablets

**Name:** Ubrogepant

**Other Names:**

- UBRELVY

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Double-Blind Period: Placebo for Ubrogepant

**Description:** Oral Tablets

**Name:** Placebo for Ubrogepant

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** A migraine day is defined as any calendar day on which a headache occurs which meets criteria listed in the protocol as per eDiary.

**Measure:** Change From Baseline in Number of Migraine Days Occurring During Perimenstrual Period (PMP)

**Time Frame:** Up to approximately 16 Weeks

**Description:** An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.

**Measure:** Number of Participants With Adverse Events (AEs)

**Time Frame:** Up to approximately 68 Weeks

#### Secondary Outcomes

**Description:** A headache day is defined as any calendar day on which headache pain lasting 2 hours or longer occurs unless an acute headache medication was used after the start of the headache, in which case no minimum duration will be specified.

**Measure:** Change From Baseline in Number of Headache Days Occurring During Perimenstrual Period (PMP)

**Time Frame:** Up to approximately 16 Weeks

**Description:** A headache day is defined as any calendar day on which headache pain lasting 2 hours or longer occurs unless an acute headache medication was used after the start of the headache, in which case no minimum duration will be specified.

**Measure:** Change From Baseline in Number of Moderate or Severe Headache Days During Perimenstrual Period (PMP)

**Time Frame:** Up to approximately 16 Weeks

**Description:** A migraine day is defined as any calendar day on which a headache occurs which meets criteria listed in the protocol as per eDiary.

**Measure:** Change From Baseline in Number of Migraine Days With Moderate or Severe Headache During Perimenstrual Period (PMP)

**Time Frame:** Up to approximately 16 Weeks

**Description:** Functional Disability Scale (FDS) is a single item used to measure the participant's level of functional disability. Participants will be asked to rate the performance of daily activities in the past 24 hours using 4 response options ranging from "No disability, able to function normally" to "Severely impaired, cannot do all or most things, bed rest may be necessary."

**Measure:** Percentage of Participants With No Disability/ Mild Impairment for most (>= 65%) of PMP Days

**Time Frame:** Up to approximately 16 Weeks

**Description:** An acute medication use day is defined as any day on which a participant reports, per eDiary, the intake of allowed medication(s) for the acute treatment of migraine.

**Measure:** Change From Baseline in Acute Medication Use Days During the Perimenstrual Period (PMP)

**Time Frame:** Up to approximately 16 Weeks

**Description:** A migraine day is defined as any calendar day on which a headache occurs which meets criteria listed in the protocol as per eDiary.

**Measure:** Percentage of Participants Achieving >= 50% Reduction in Number of Migraine Days During the Perimenstrual Period (PMP)

**Time Frame:** Up to approximately 16 Weeks

**Description:** Activity Level is a single-item used to assess overall limitations with performing daily activities over 24 hours with a 5-level response ranging from "Not at all limited" to "Unable to do daily activities."

**Measure:** Percentage of Participants Achieving "Not at all limited" or "A little limited" Daily Activity Level for Most (>= 65%) of PMP Days

**Time Frame:** Up to approximately 16 Weeks

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* At least a 1-year history of migraine with or without aura.
* Have experienced migraine attacks in at least 2 of 3 perimenstrual periods (PMPs) during the screening period.
* Collection of daily eDiary data for 3 perimenstrual periods during the up to 16-week screening period to confirm a menstrual migraine (MM) diagnosis.
* Have regular menstrual cycles of between 21-35 days in length.
* Less than 15 headache days per month.
* At least 70% compliance completing screening period and at least 4 out of 5 days of ediary data in each of 3 screening PMP.

Exclusion Criteria:

* History of migraine with brainstem aura, hemiplegic migraine, or retinal migraine.
* Clinically significant history of cardiovascular or cerebrovascular disease per the investigator's opinion.
* Clinically significant abnormalities in the physical examination as determined by the investigator.
* Clinically significant hematologic, endocrine, pulmonary, renal, hepatic, gastrointestinal, gynecological, or neurologic disease per the investigator's opinion.
* Acute headache medication overuse.

**Minimum Age:** 18 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** abbvieclinicaltrials@abbvie.com

**Name:** ABBVIE CALL CENTER

**Phone:** 844-663-3742

**Role:** CONTACT

#### Overall Officials

**Official 1:**

**Affiliation:** AbbVie

**Name:** ABBVIE INC.

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**Access Criteria:** Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

**Description:** AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

**Info Types:**

- STUDY_PROTOCOL

- SAP

- CSR

**IPD Sharing:** YES

**Time Frame:** For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/

**URL:** https://vivli.org/ourmember/abbvie/

### References Module

#### See Also Links

**Label:** Related Info

**URL:** https://www.abbvieclinicaltrials.com/study/?id=M23-714

## 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

### 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

### Condition Browse Module - Meshes

- ID: D000008881

- Term: Migraine Disorders

### Misc Info Module

- Version Holder: 2024-05-31
