Efficacy and Safety Study of Rimegepant in Episodic Migraine Prevention With Multiple Dosing Regimens
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ClinicalTrials.gov Identifier: NCT05217927 |
Recruitment Status :
Active, not recruiting
First Posted : February 1, 2022
Last Update Posted : May 10, 2024
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Migraine | Drug: Rimegepant 75mg daily dosing Drug: Rimegepant 75mg every other day dosing Drug: Placebo comparator dosing | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 452 participants |
Allocation: | Randomized |
Intervention Model: | Sequential Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Phase 4 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Rimegepant in Episodic Migraine Prevention With Multiple Dosing Regimens |
Actual Study Start Date : | March 4, 2022 |
Estimated Primary Completion Date : | October 14, 2024 |
Estimated Study Completion Date : | December 8, 2024 |
Arm | Intervention/treatment |
---|---|
Experimental: Rimegepant 75mg Orally Disitegrating Tablet (ODT)daily dosing
Double-blind Treatment Phase: Rimegepant 75 mg ODT dosed daily Open-Label Extension Phase: Rimegepant 75 mg ODT dosed daily |
Drug: Rimegepant 75mg daily dosing
Daily |
Experimental: Rimegepant 75mg Orally Disintegrating Tablet (ODT)every other day dosing
Double-blind Treatment Phase: Rimegepant 75 mg ODT every other day dosing alternating with matching placebo
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Drug: Rimegepant 75mg every other day dosing
Every other day |
Placebo Comparator: Placebo comparator dosing
Double-blind Treatment Phase: matching placebo dosed daily
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Drug: Placebo comparator dosing
Placebo comparator |
- Mean change from the Observation Phase in the number of migraine days per month over the entire Double-blind Treatment Phase (Weeks 1-12) [ Time Frame: 3 months (12 weeks) ]Change from baseline in mean number of migraine days per month
- Proportion of subjects with > 50% reduction from the Observation Phase (Weeks 1 to 12). [ Time Frame: 3 months (12 weeks) ]Number of moderate to severe migraine days per month over the entire Double-blind Treatment Phase
- Mean change from the Observation Phase. [ Time Frame: Weeks 9 to 12 ]Number of migraine days per month in the last 4 weeks of the Double-blind Treatment Phase.
- Mean change from the Observation Phase [ Time Frame: Weeks 1 to 4 ]number of migraine days per month in the first 4 weeks of the Double-blind Treatment Phase.
- Mean number of acute migraine-specific medication days per month. [ Time Frame: Weeks 1 to 12 ]Over the entire Double-blind Treatment Phase. Acute migraine-specific medications are triptans and ergotamine.
- Mean change from baseline in the Migraine-Specific Quality-of-Life Questionnaire (MSQ) restrictive role function. [ Time Frame: At Week 12 ]Domain score of the Double-blind Treatment Phase.
- Number and percentage of subjects with AEs by intensity. [ Time Frame: 24 Weeks ]Serious adverse events (SAEs), AEs leading to study drug discontinuation, and grade 3 to 4 laboratory test abnormalities during the Double-blind Treatment and Open-label Extension Phases.
- Number and percentage of subjects treated with rimegepant with AST or ALT elevations. [ Time Frame: 24 Weeks ]>3x ULN concurrent (i.e., on the same laboratory collection date) with total bilirubin > 2x ULN during the Double-blind Treatment and Open-label Extension Phases.
- Number and percentage of subjects treated with rimegepant with hepatic-related AEs [ Time Frame: 24 Weeks ]By intensity and hepatic-related AEs leading to study drug discontinuation during the Double-blind Treatment and Open-label Extension Phases.
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
1) Target Population: Subject has at least 1 year history of episodic migraine (with or without aura) consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd Edition, including the following:
- Age of onset of migraines prior to 50 years of age
- Migraine attacks, on average, lasting 4-72 hours if untreated
- Per subject report, 4-14 migraine attacks per month within the last 3 months prior to the Screening Visit (month is defined as 4 weeks for the purpose of this protocol
Exclusion Criteria:
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Sex and Reproductive Status:
- WOCBP who are unwilling or unable to use an acceptable contraceptive method or abstinence to avoid pregnancy for the entire study and for 60 days after the last dose of study drug
- Women who are pregnant or breastfeeding
- Women with a positive pregnancy test at screening or prior to study drug administration
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Prohibited Medications:
- Use of prophylactic migraine medication within 30 days prior to the Screening Visit.
- History of use of analgesics (e.g., non-steroidal anti-inflammatory drugs [NSAIDs] or acetaminophen) on ≥ 15 days per month during the 3 months (12 weeks) prior to the Screening Visit.
- Use of medication accepted for treatment of acute migraine for a nonmigraine indication on ≥ 15 days per month during the 3 months (12 weeks) prior to the Screening Visit.
- Subjects who previously discontinued biologic migraine medication must have done so at least 6 months (24 weeks) prior to the Screening Visit.
- Subjects taking a prohibited medication as defined per protocol
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05217927
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Pfizer |
ClinicalTrials.gov Identifier: | NCT05217927 |
Other Study ID Numbers: |
BHV3000-404 C4951010 ( Other Identifier: Alias Study Number ) 2021-005239-22 ( EudraCT Number: CTIS (EU) ) 2021-005239-22 ( Registry Identifier: CTIS (EU) ) |
First Posted: | February 1, 2022 Key Record Dates |
Last Update Posted: | May 10, 2024 |
Last Verified: | May 2024 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan 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. |
URL: | https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
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