CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 897 enrolled
Drug / intervention
Rimegepant 25 MG +2 moredrug
Likely dose
Rimegepant 25 mg or 75 mg orally disintegrating tablet (single dose)AI-extracted
Key inclusion· 6
  • ✓At least 1 year history of migraines (with or without aura) with age of onset prior to 50 years
  • ✓At least 2 migraine headache attacks of moderate or severe intensity in each of the 3 months prior to Screening Visit
  • ✓Less than 15 days with headache (migraine or non-migraine) per month in each of the 3 months prior to Screening and during Screening Period
  • ✓Not more than 8 attacks of moderate to severe intensity per month within the last 3 months
Key exclusion· 8
  • ✕History of migraine with brainstem aura (basilar migraine), hemiplegic migraine, or retinal migraine
  • ✕Analgesic overuse: ≥15 days per month of NSAIDs or acetaminophen during the 3 months prior to Screening
  • ✕History of uncontrolled, unstable, or recently diagnosed cardiovascular disease (ischemic heart disease, coronary artery vasospasm, cerebral ischemia)
  • ✕MI, ACS, PCI, cardiac surgery, stroke, or TIA during the 6 months prior to screening

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05399459
NCT05399459Phase 3Completed
CompareCT.gov

Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of Rimegepant for the Acute Treatment of Migraine in Japanese Subjects

Pfizer·interventional·Posted Jun 1, 2022·Updated Mar 7, 2025

In Brief

A Phase 3 clinical trial evaluating Rimegepant 25 MG, Rimegepant 75 MG, and 1 other intervention for Migraine. Completed, enrolled 897 participants across 50 sites.

Detailed Summary

This study is being conducted to determine the appropriate dose of rimegepant in Japanese subjects, as well as to evaluate the efficacy, safety, and tolerability of rimegepant in Japanese subjects for the acute treatment of migraine.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMigraine
CountriesJapan
Collaborators--

Timeline

Phase 3CompletedFinished
2023202420252026
First PostedJun 1, 2022
Enrollment StartAug 9, 2022
Primary CompletionJan 19, 2024
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 4.1 years ago

Interventions

Rimegepant 25 MGdrug

Single dose of 25 mg orally disintegrating tablet of rimegepant

Rimegepant 75 MGdrug

Single dose of 75 mg orally disintegrating tablet of rimegepant

Placebodrug

Matching placebo tablet