Phase 4
N=250
Safety and Tolerability Study of Daily Dosing Rimegepant in Episodic Migraine Prevention
Migraine · Episodic Migraine · Phonophobia · Photophobia
Bottom Line
View on ClinicalTrials.gov: NCT05207865 ↗Enrolled (actual)
250
Serious AEs
0.4%
Results posted
Sep 2025
Primary outcome: Primary: Number of Participants With On-Treatment Adverse Events (AEs) (Frequency >=5%) According to Intensity — 33; 17; 17 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Rimegepant (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Jul 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With On-Treatment Adverse Events (AEs) (Frequency >=5%) According to Intensity |
33; 17; 17 | — |
| PRIMARY Number of Participants With On-Treatment Serious Adverse Events (SAEs) |
— | — |
| PRIMARY Number of Participants With AEs Leading to Study Drug Discontinuation |
7 | — |
| PRIMARY Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Common Technical Criteria for Adverse Events- Division of Acquired Immune Deficiency Syndrome (CTCAE/DAIDS) Toxicity Grading Scale |
0; 0; 0; 0; 1; 0 | — |
| PRIMARY Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Food and Drug Administration (FDA) Toxicity Grading Scale |
0; 4; 0; 0; 1; 0 | — |
Summary
The purpose of this study is to further evaluate the long-term safety and tolerability of daily dosing of rimegepant for the prevention of episodic migraine.
Eligibility Criteria
Key Inclusion Criteria
- 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)
- Subjects ≥ 18 years
Key Exclusion Criteria
- Subject history with current evidence of uncontrolled, unstable or recently diagnosed cardiovascular disease, such as ischemic heart disease, coronary artery vasospasm, and cerebral ischemia. Subjects with myocardial infarction (MI), acute coronary syndrome (ACS), percutaneous coronary intervention (PCI), cardiac surgery, stroke or transient ischemic attack (TIA) during the 6 months (24 weeks) prior to the Screening Visit.
- Uncontrolled hypertension (high blood pressure) or uncontrolled diabetes.
- The subject has a history or current evidence of any unstable medical conditions (e.g., history of congenital heart disease or arrhythmia, known or suspected infection, hepatitis B or C, or cancer) that, in the investigator's opinion, would expose them to undue risk of a significant adverse event (AE) or interfere with assessments of safety or efficacy during the course of the study
- History of use of opioid- or barbiturate- (e.g. butalbital) containing medication for 4 or more days per month during the 3 months (12 weeks) prior to the Screening Visit
- WOCBP who are unwilling or unable to use an acceptable contraceptive method or abstinence to avoid pregnancy for the entire study and for 28 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
Data sourced from ClinicalTrials.gov (NCT05207865). 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.