Consistency of Response With Rimegepant in Acute Treatment of Migraine
NCT ID: NCT06898047
Last Updated: 2025-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
250 participants
OBSERVATIONAL
2025-11-15
2026-07-31
Brief Summary
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Detailed Description
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The study will be conducted in the United Kingdom (UK). Potential participants will be identified and selected from UK healthcare institutions. Both patients diagnosed with episodic and chronic migraine will be included, with a split of approximately 50% of each group. Participants will be enrolled into the study over a period of approximately 6 months. The total data collection period will be approximately 9 months. Potentially eligible patients will receive briefing materials during a routine in-person consultation, or via email. Interested patients will use a link and a unique ID and PIN to complete a study eligibility screener within the study web application. The screener will consist of a series of demographic and clinical history questions. Participants who successfully complete the eligibility will then be able to proceed to the consent stage. Informed consent will also be provided within the study web application.
Consented participants will be required to complete a series of baseline demographic and clinical questions within a window of 72h from registration. A completion reminder will be sent every 24h until the completion window closes. Each participant will be followed up for 12 weeks. During this period, participants will receive an SMS with a link to the study website at the same time every day. A single click on the phone will take participants to the daily migraine survey. Two custom questions asking about migraine symptom occurrence and rimegepant use in the previous 24h will be presented to every participant daily from Day 1 to Day 84. A series of custom follow-up questions, asking further information about any migraine symptoms and related treatment, will be presented based on participant responses to questions 1 and 2 . A completion window of four days (96h) will be allowed for the daily questions. In case participants are still experiencing some migraine symptoms when prompted, they will be able to save their responses and return at a later time within the completion window. On Days 0, 28, 56 and 84 of follow-up, a menstruation question will be presented to all participants. At the end of the 12-week follow-up, the mTOQ-6 Likert version and the TSQM-II questionnaire will be presented to all participants.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Rimegepant users
Participants with current prescription of rimegepant for acute treatment of migraine
Rimegepant for acute migraine treatment
Rimegepant for acute migraine treatment
Interventions
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Rimegepant for acute migraine treatment
Rimegepant for acute migraine treatment
Eligibility Criteria
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Inclusion Criteria
2. At least 18 years of age.
3. Migraine diagnosis confirmed by healthcare professional.
4. Current prescription of rimegepant for acute treatment of migraine.
5. Experienced at least 4 migraine attacks per month prior to study enrolment.
6. 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.
7. 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.
Exclusion Criteria
2. 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.
3. Current prescription of any of the following medications:
* Strong inhibitors of CYP3A4
* Strong or moderate inducers of CYP3A4
4. Patients participating in a migraine-related clinical trial.
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer
London, , United Kingdom
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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CORRELATE-UK
Identifier Type: OTHER
Identifier Source: secondary_id
C4951071
Identifier Type: -
Identifier Source: org_study_id