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 : January 9, 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 :||February 15, 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. Severity will be assessed as the worst severity observed while the subject is on treatment.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03732638
|Contact: Robert Bermanfirstname.lastname@example.org|
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