Consistency of Response With Rimegepant in Acute Treatment of Migraine

NCT06898047 | Active Not Recruiting FDA Drug

• 2 other identifiers: C4951071CORRELATE-UK
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

This is a non-interventional, prospective study that will enroll participants with migraine in the United Kingdom currently in use of rimegepant to acutely treat migraine attacks. Participants will be followed up for up to 12 weeks and will complete a daily questionnaire to self-report the consistency of response to rimegepant in acute treatment of migraine.

Conditions

Migraine

Keywords

Migraine; Acute migraine treatment; rimegepant

Outcome Measures

Primary Outcomes (1)

• Time to Meaninful Pain Relief (MPR) post-dosing

  Proportion of rimegepant-treated attacks with reported MPR: within 1 hour post dose; 1-2 hours post dose; Over 2 hours up to 4 hours post dose; More than 4 hours post dose; who have not achieved MPR and took the medication more than 2 hours before completing the survey; who have not achieved MPR and took the medication less than 2 hours before completing the survey

  Daily (within 24hs post dose)

Secondary Outcomes (3)

• Time to improvement in non-pain symptoms post-dosing

  Daily (within 24hs post dose)

• Acute migraine treatment optmization

  12 weeks follow up

• Acute migraine treatment optmization

  12 weeks follow up

Study Arms (2)

Rimegepant users

Participants with current prescription of rimegepant for acute treatment of migraine

Drug: Rimegepant for acute migraine treatment

Rimegepant-treated attacks

Migraine attacks treated with rimegepant

Drug: Rimegepant for acute migraine treatment

Interventions

Rimegepant for acute migraine treatment DRUG

Rimegepant for acute migraine treatment

Rimegepant users; Rimegepant-treated attacks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult participants living in the United Kingdom, with a migraine diagnosis confirmed by a healthcare professional, experiencing at least 4 migraine attacks per month, with a current prescription of rimegepant for acute treatment of migraine, and, if receving preventive migraine treatment, must be stable before enrollment. Participants will be excluded if they are currently using rimegepant as preventive migraine treatment, if present other specific neurological conditions, if currently prescribed with drugs that may indude or inhibits CYP3A4, or if they are participating in a migraine-related clinical trial. All participants enrolled must acknowledge their participation in the study informed consent.

You may qualify if:

• UK resident.
• At least 18 years of age.
• Migraine diagnosis confirmed by healthcare professional.
• Current prescription of rimegepant for acute treatment of migraine.
• Experienced at least 4 migraine attacks per month prior to study enrolment.
• In the case of participants receiving preventive migraine treatment:
• For oral preventives, the treatment must be "stable" i.e., final dosing regimen has been found.
• For migraine preventives administered monthly, the participant must have had their most recent treatment within the 3 weeks prior to study enrolment.
• For migraine preventives administered quarterly, the participant must have had their most recent treatment within the 2 months prior to study enrolment.
• If the last treatment is not within the stipulated period, participants will be asked to provide the date of the next scheduled treatment, after which the participant may be invited back to enrol into the study.
• Evidence of a personally signed (or acknowledged if obtained electronically or online) and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study.

You may not qualify if:

• Current use of rimegepant as a preventive migraine medication.
• Current diagnosis of any of the following conditions:
• new daily persistent headache
• chronic daily headache
• cluster headache
• post-traumatic headache
• hemicrania continua
• major depression
• pain syndromes other than migraine (e.g. fibromyalgia)
• psychiatric conditions (e.g., schizophrenia)
• dementia
• significant neurological disorders other than migraine.
• Current prescription of any of the following medications:
• Strong inhibitors of CYP3A4
• Strong or moderate inducers of CYP3A4

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer

London, United Kingdom

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Migraine Disorders

Interventions

rimegepant sulfate

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2025
• First Posted: March 27, 2025
• Study Start: November 15, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: May 7, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)