CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 241 enrolled
Drug / intervention
Rimegepant 75mg Orally Disintegrating Tablets (ODT)drug
Likely dose
Rimegepant 75 mg orally disintegrating tablet, up to 1 tablet per day at time of migraine attackAI-extracted
Key inclusion· 7
  • ✓Age ≥18 years
  • ✓At least 1 year history of migraines (with or without aura) per ICHD-3 criteria, with onset before age 50
  • ✓6-18 migraine attacks of moderate or severe intensity per month in last 3 months before screening
  • ✓Untreated migraine attacks last 4-72 hours on average
Key exclusion· 12
  • ✕Basilar migraine with brainstem aura or hemiplegic migraine
  • ✕Recent cardiovascular/cerebrovascular events: MI, ACS, PCI, cardiac surgery, stroke, or TIA in 6 months prior to screening
  • ✕Poorly controlled hypertension or diabetes; systolic BP >150 mmHg or diastolic >100 mmHg after 10 minutes rest is exclusionary
  • ✕Current major depression or major depressive episode within last 12 months

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

Search/NCT05371652
NCT05371652Phase 3Completed
CompareCT.gov

A Multicenter, Open Label, Long-term Safety Study of BHV3000 for the Acute Treatment of Migraine in Chinese Subjects

Pfizer·interventional·Posted May 12, 2022·Updated Feb 20, 2025

In Brief

A Phase 3 clinical trial evaluating Rimegepant 75mg Orally Disintegrating Tablets (ODT) for Acute Migraine. Completed, enrolled 241 participants across 26 sites.

Detailed Summary

This trial is to evaluate the long-term safety and tolerability of Rimegepant 75mg ODT in Chinese subjects with migraine

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Migraine
CountriesChina
Collaborators--

Timeline

Phase 3CompletedFinished
2023202420252026
First PostedMay 12, 2022
Enrollment StartMay 19, 2022
Primary CompletionFeb 6, 2024
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 4.1 years ago

Interventions

Rimegepant 75mg Orally Disintegrating Tablets (ODT)drug

One rimegepant (BHV3000) 75mg orally disintegrating tablet (up to 1 tablet per day) at the time of their migraine attack