Efficacy and Safety Trial of Rimegepant for Migraine Prevention in Adults
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|ClinicalTrials.gov Identifier: NCT03732638|
Recruitment Status : Recruiting
First Posted : November 6, 2018
Last Update Posted : April 17, 2019
|Condition or disease||Intervention/treatment||Phase|
|Migraine||Drug: Rimegepant Drug: Placebo||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||A Phase 2/3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Rimegepant in Migraine Prevention|
|Actual Study Start Date :||November 14, 2018|
|Estimated Primary Completion Date :||September 30, 2019|
|Estimated Study Completion Date :||November 30, 2020|
|Active Comparator: BHV-3000 (Rimegepant)||
BHV-3000 (rimegepant) 75 mg tablet
|Placebo Comparator: Placebo Comparator||
75mg matching placebo
- Change from baseline in mean number of migraine days per month [ Time Frame: Mean number of migraine days per month as assessed over 3 months (12 weeks) ]Change from baseline in mean number of migraine days per month as measured over the 12-week double-blind phase of the study.
- Achievement of at least a 50% reduction from baseline in mean monthly migraine days. [ Time Frame: baseline to end of Week 12 ]Achievement of at least a 50% reduction from baseline in mean monthly migraine days over course of the double-blind treatment phase.
- The mean number of rescue medication days per month. [ Time Frame: baseline to end of week 12 as measure per month ]The mean number of rescue medication days per month over the course of the double-blind, treatment phase. Rescue medications include the rescue medications defined in this protocol.
- Adverse events. [ Time Frame: baseline to end of Week 12 ]Adverse events that occur in at least 5% of treated subjects; the frequency of unique subjects with serious adverse events, adverse events leading to discontinuation and clinically significant laboratory abnormalities, as reported on case report forms.
- The frequency of AST or ALT elevations. [ Time Frame: baseline to end of Week 12 ]The frequency of AST or ALT elevations > 3x ULN, concurrently with bilirubin elevations > 2x ULN, will be assessed by tabulating the number of unique subjects with this pairing of events.
- The frequency of hepatic-related adverse events and hepatic-related treatment. [ Time Frame: baseline to end of Week 12 ]The frequency of hepatic-related adverse events and hepatic-related treatment discontinuations will be tabulated from case report forms and will be based on unique subjects reporting such events.
- The mean change from baseline in the MSQ role function [ Time Frame: baseline to end of Week 12 ]The mean change from baseline in the MSQ role function - restrictive domain score at Week 12 of the double-blind treatment phase.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03732638
|Contact: Robert Bermanemail@example.com|
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