Phase 4
N=699
Efficacy and Safety Study of Rimegepant in Episodic Migraine Prevention With Multiple Dosing Regimens
Migraine
Bottom Line
View on ClinicalTrials.gov: NCT05217927 ↗Enrolled (actual)
699
Serious AEs
1.0%
Results posted
Dec 2025
Primary outcome: Primary: Mean Change From Observation Phase (OP) in the Number of Migraine Days Per Month Over Entire DBT Phase (Weeks 1 to 12) — -2.9; -4.0; -2.2 Days per month — p==0.0220
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Rimegepant 75mg daily dosing (Drug); Rimegepant 75mg every other day dosing (Drug); Placebo comparator dosing (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Oct 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Observation Phase (OP) in the Number of Migraine Days Per Month Over Entire DBT Phase (Weeks 1 to 12) |
-2.9; -4.0; -2.2 | =0.0220 sig |
| SECONDARY Percentage of Participants With Greater Than Equal to (>=) 50 Percent (%) Reduction From OP in Number of Moderate to Severe Migraine Days Per Month Over the Entire DBT Phase (Weeks 1 to 12) |
40.5; 58.1; 33.3 | =0.0966 |
| SECONDARY Mean Change From OP in the Number of Migraine Days Per Month in the Last 4 Weeks (Weeks 9 to 12) of DBT Phase |
-3.0; -4.2; -2.8 | =0.5314 |
| SECONDARY Mean Change From OP in the Number of Migraine Days Per Month in the First 4 Weeks (Weeks 1 to 4) of DBT Phase |
-2.7; -3.6; -1.5 | =0.0002 sig |
| SECONDARY Mean Number of Acute Migraine-Specific Medication Days Per Month Over the Entire DBT Phase (Weeks 1 to 12) |
2.3; 1.5; 2.8 | =0.1440 |
| SECONDARY Mean Change From Baseline in the Migraine-Specific Quality-of-Life Questionnaire (MSQoL) Version 2.1 Restrictive Role Function Domain Score at Week 12 of the DBT Phase |
21.3; 29.1; 18.9 | =0.2029 |
| SECONDARY Number of Participants With Mild, Moderate and Severe Adverse Events (AEs) in DBT Phase |
73; 86; 91; 42; 22; 43 | — |
| SECONDARY Number of Participants With Mild, Moderate and Severe AEs OLE Phase |
65; 57; 65; 30; 22; 25 | — |
| SECONDARY Number of Participants With Serious Adverse Events (SAEs) in DBT Phase |
3; 2; 1 | — |
| SECONDARY Number of Participants With SAEs in OLE Phase |
2; 2; 2 | — |
| SECONDARY Number of Participants With AEs Leading to Study Drug Discontinuation in DBT Phase |
6; 1; 4 | — |
| SECONDARY Number of Participants With AEs Leading to Study Drug Discontinuation in OLE Phase |
4; 1; 1 | — |
| SECONDARY Number of Participants With Grade 3 to 4 Laboratory Abnormalities in DBT Phase |
0; 0; 1; 0; 1; 1 | — |
| SECONDARY Number of Participants With Grade 3 to 4 Laboratory Abnormalities in OLE Phase |
1; 1; 1; 0; 1; 0 | — |
| SECONDARY Number of Participants With Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) Elevations > 3* Upper Limit of Normal (ULN) Concurrent With (Total Bilirubin) TBL >2*ULN in DBT Phase |
0; 0; 0 | — |
| SECONDARY Number of Participants With AST or ALT Elevations > 3* ULN Concurrent With TBL >2*ULN in OLE Phase |
0; 0; 0 | — |
| SECONDARY Number of Participants With Hepatic-Related AEs in the DBT Phase |
7; 8; 8 | — |
| SECONDARY Number of Participants With Hepatic-Related AEs in the OLE Phase |
11; 4; 6 | — |
| SECONDARY Number of Participants With Hepatic-Related AEs Leading to Study Drug Discontinuation in the DBT Phase |
4; 1; 2 | — |
| SECONDARY Number of Participants With Hepatic-Related AEs Leading to Study Drug Discontinuation in the OLE Phase |
1; 1; 1 | — |
Summary
The purpose of this study is to compare the efficacy and safety of daily and every other day dosing of rimegepant to placebo as a preventive treatment for episodic migraine.
Eligibility Criteria
Inclusion Criteria
- 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
- 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
- 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
Data sourced from ClinicalTrials.gov (NCT05217927). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.