## Protocol Section
### Identification Module
**NCT ID:** NCT06412965

**Acronym:** Adelphi DSP

**Brief Title:** Reliability of Rimegepant for the Acute Treatment of Migraine

**Official Title:** Evaluation of the Reliability of Effect of Rimegepant for the Acute Treatment of Migraine Across Multiple Attacks

#### Organization Study ID Info
**ID:** C4951066
#### Organization
**Class:** INDUSTRY
**Full Name:** Pfizer
### Status Module
#### Completion Date
**Date:** 2024-01-03

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-14

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-08

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2024-01-03

**Type:** ACTUAL

#### Start Date
**Date:** 2024-01-02

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-14
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-16
**Study First Submit QC Date:** 2024-05-08
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Pfizer

#### Responsible Party

**Type:** SPONSOR

### Description Module

**Brief Summary:** This protocol describes the analysis of the Adelphi Real World (ARW) Migraine Disease Specific Programme(TM) 2022, a cross-sectional study which used both physician and patient surveys to assess the perception of the acute treatment for migraine attacks.

**Detailed Description:** This is a retrospective database study that aims to explore the reliability of effect with acute use of Rimegepant, to evaluate the satisfaction with Rimegepant, to evaluate willingness to continue using Rimegepant, and to explore proportion optimized on treatment with Rimegepant. The data will be extracted from the Adelphi Real World (ARW) Migraine Disease Specific ProgrammeTM (DSP) 2022 database, which was conducted across a number of countries including United States, between May 2022 and November 2022. The DSP was an observational study of clinical practice. Treatment practice data were collected by physicians (physician survey) who were asked to provide information for the next 10 patients consulting for migraine. These patients were then invited to fill out a self-completion form (patient survey) providing their own assessment on the disease and treatments.

### Conditions Module

**Conditions:**

- Migraine Disorders

### Design Module

#### Design Info

**Observational Model:** OTHER

**Time Perspective:** RETROSPECTIVE

#### Enrollment Info

**Count:** 91

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Physicians who were enrolled in the Adelphi Migraine Disease Specific Programme (DSP)™

**Label:** Physician Survey

#### Arm Group 2

**Description:** Patients who were enrolled in the Adelphi Migraine Disease Specific Programme (DSP)™

**Label:** Patient survey

### Outcomes Module

#### Primary Outcomes

**Description:** Frequency of patients for which the physician reports that fail to achieve pain freedom at 2 hours post dose on more than half of occasions measured by using answers on the physician survey

**Measure:** Failure to achieve pain freedom within 2 hours post dose (physician perspective)

**Time Frame:** 2 hours post dose

**Description:** Frequency of patients who reported migraine pain freedom within 2 hours post dosing in 0 out of every 5 attacks, 1 out of every 5 attacks, 2 out of every 5 attacks, 3 out of every 5 attacks, 4 out of every 5 attacks, or 5 out of every 5 attacks measured by using answers on the patient survey

**Measure:** Number of migraine attacks acute treatment achieves pain freedom within 2 hours post dose (patient perspective)

**Time Frame:** 2 hours post dose

**Description:** Description of the reasons why the physician chooses the acute treatment considering the following domains: type of control and effects; formulation/dosage; quality of life; side effects and safety; patient types; and general attributes measured by using answers on the physician survey

**Measure:** Reason for choice of current acute treatment - 'consistency of response after repeated use' (physician perspective)

**Time Frame:** Over the last 3 months prior completing the survey

**Description:** Frequency with which the physician is extremely satisfied, satisfied, slightly satisfied, neither satisfied not dissatisfied, slightly dissatisfied, or extremely dissatisfied with the patient´s acute treatment prescription measured by using answers on the physician survey

**Measure:** Satisfaction with current acute treatment (physician perspective)

**Time Frame:** Over the last 3 months prior completing the survey

**Description:** Description of the reasons why the physician is not satisfied with patient´s treatment prescription measured by using answers on the physician survey

**Measure:** Drivers for lack of satisfaction with current acute treatment (physician perspective)

**Time Frame:** Over the last 3 months prior completing the survey

**Description:** Frequency of patients who reported being extremely satisfied, satisfied, slightly satisfied, neither satisfied not dissatisfied, slightly dissatisfied, or extremely dissatisfied with the treatment for their migraine attacks measured by using answers on the patient survey

**Measure:** Satisfaction with current acute treatment (patient perspective)

**Time Frame:** Over the last 3 months prior completing the survey

**Description:** Description of the reasons why the patients are not satisfied or extremely satisfied with their acute treatment measured by using answers on the patient survey

**Measure:** Drivers for lack of satisfaction with current acute treatment (patient perspective)

**Time Frame:** Over the last 3 months prior completing the survey

**Description:** Frequency of patients who reported willingness to continue using their acute treatment, categorized into definitely yes, probably yes, do not know, probably not, or definitely not measured by using answers on the patient survey

**Measure:** Patient willingness to continue use of acute treatment (patient perspective)

**Time Frame:** Over the last 3 months prior completing the survey

**Description:** Mean and median of total scores. The mTOQ-6 score is calculated by summing individual question scores (score range of 6-24), with higher scores indicating better acute treatment optimization

**Measure:** Migraine treatment optimization questionnaire (mTOQ6)

**Time Frame:** Over the last 3 months prior completing the survey

**Description:** Frequency of each item with the response options (never, rarely, less than half of the time, or half of the time or more)

**Measure:** Migraine Treatment Optimization Questionnaire (m-TOQ6)

**Time Frame:** Over the last 3 months prior completing the survey

**Description:** Frequency of patients who usually take their acute treatment: before any sign of a migraine attack, but in anticipation of one starting; or at the first sign of a migraine attack (before the pain starts); or when the pain starts; or after the pain has started and have an idea of how severe it is measured by using answers on the patient survey

**Measure:** When patients takes acute prescription treatment

**Time Frame:** Over the last 3 months prior completing the survey

**Description:** Average number of days per month the patient takes the acute treatment measured by using answers on the patient survey

**Measure:** How many days per month patient takes acute prescription treatment

**Time Frame:** Over the last 3 months prior completing the survey

### Eligibility Module

**Eligibility Criteria:** Inclusion criteria

* Patients who have episodic and/or chronic migraine
* Patients age \> 18
* Currently prescribed rimegepant for the acute treatment of migraine

Exclusion criteria

* currently prescribed rimegepant for prevention of migraine or for both the acute treatment \& prevention of migraine
* Currently prescribed an acute treatment for migraine other than rimegepant

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Physician personally responsible for treatment decision of migraine patients were enrolled in the survey. Each physician then enrolled consecutive patients to complete a patient self-completion questionnaire.

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** New York

**Country:** United States

**Facility:** Pfizer

**State:** New York

**Zip:** 10001

#### Overall Officials

**Official 1:**

**Affiliation:** Pfizer

**Name:** Pfizer CT.gov Call Center

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**Description:** Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

**IPD Sharing:** NO

### References Module

#### See Also Links

**Label:** To obtain contact information for a study center near you, click here.

**URL:** https://pmiform.com/clinical-trial-info-request?StudyID=C4951066

## 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: 2024-05-31
