Rimegepant for Migraine

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Migraine+1 More
Rimegepant - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This study is being conducted to evaluate the efficacy and tolerability of rimegepant in a population of adults that are unsuitable for triptan medications due to a previous intolerance, lack of efficacy, or contraindication (including a history of clinically-relevant cardiovascular disease).

Eligible Conditions
  • Migraine

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: 2 hours post-dose

2 hours post-dose
Compare the efficacy of rimegepant with placebo in the acute treatment of migraine, as measured by migraine headache pain relief at 2-hours post-dose during the Double-Blind Treatment (DBT) Phase.

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

Rimegepant
1 of 2
Placebo
1 of 2

Experimental Treatment

Non-Treatment Group

600 Total Participants · 2 Treatment Groups

Primary Treatment: Rimegepant · Has Placebo Group · Phase 4

Rimegepant
Drug
Experimental Group · 1 Intervention: Rimegepant · Intervention Types: Drug
PlaceboPlaceboComparator Group · 2 Interventions: Rimegepant, Placebo · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rimegepant
2011
Completed Phase 3
~12080

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 2 hours post-dose

Who is running the clinical trial?

Biohaven Pharmaceuticals, Inc.Lead Sponsor
46 Previous Clinical Trials
31,589 Total Patients Enrolled
13 Trials studying Migraine
14,208 Patients Enrolled for Migraine

Eligibility Criteria

Age 18+ · All Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Migraine attacks present for more than 1 year with the age of onset prior to 50 years of age.
You have at least 4 to 14 migraine days per month on average across the 3 months prior to the Screening Visit.
You have had less than 15 headache days (migraine or non-migraine) per month in each of the 3 months prior to the Screening Visit and throughout the Screening Phase.
Subjects must be able to distinguish migraine attacks from tension/cluster headaches.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 7th, 2021

Last Reviewed: November 13th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.