Efficacy and Tolerability of Rimegepant for the Acute Treatment of Migraine in Adults Unsuitable for Triptan Use

Study Overview
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Brief Summary
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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).

Detailed Description
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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). Rimegepant will be further evaluated in this population with as needed use in a 12-week, open-label extension study.

Official Title
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A Phase 4, Randomized, Double-blind Placebo-Controlled, Efficacy and Tolerability Trial of Rimegepant for the Acute Treatment of Migraine in Adults Unsuitable for Triptan Use.

Conditions
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Migraine

Intervention / Treatment
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* Drug: Rimegepant
* Drug: Placebo
* Drug: Rimegepant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Migraine attacks present for more than 1 year with the age of onset prior to 50 years of age. Migraine attacks, on average, lasting about 4 - 72 hours if untreated. 4 to 14 migraine days per month on average across the 3 months prior to the Screening Visit (month is defined as 28 days for the purpose of this protocol). 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. Subjects on prophylactic migraine medication (excluding CGRP antagonists) are permitted to remain on therapy if they have been on a stable dose for at least 3 months (12 weeks) prior to the Screening Visit, and if the dose is not expected to change during the course of the study. Triptan unsuitable Exclusion Criteria: -Target Disease Exclusion: History of cluster headache, basilar migraine, or hemiplegic migraine Current medication overuse headaches Headaches occurring 15 or more days per month (migraine or non-migraine) in any of the 3 months prior to the Screening Visit Active chronic pain syndrome (such as fibromyalgia, chronic pelvic pain, complex regional pain syndrome [CRPS]) Other pain syndromes (including trigeminal neuralgia), dementia, or significant neurological disorders (other than migraine) that, in the Investigator's opinion, interfere with study assessments of safety or efficacy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rimegepant<br>Rimegepant - Double-blind (DB) Phase: One dose of rimegepant 75 mg Oral Disintegrating Tablet (ODT) Rimegepant/Rimegepant - Open-label Extension (OLE) Phase: participants receive one dose rimegepant 75 mg ODT as needed for a qualifying acute migraine. A qualifying migraine is an attack of moderate or severe headache pain intensity. Migraine headache pain intensity will be measured on a 4-point numeric rating scale (0=none, 1=mild, 2=moderate, 3=severe) | Drug: Rimegepant<br>* DB Phase: Rimegepant 75 mg Orally Disintegrating Tablet (ODT)<br>Drug: Rimegepant<br>* OLE Phase: Rimegepant 75 mg ODT in association with each of the first 5 qualifying migraines<br>|
| Placebo Comparator: Placebo<br>Placebo - Double-blind (DB) Phase: One dose of matching placebo Placebo/Rimegepant - Open-label Extension (OLE) Phase: participants receive one dose rimegepant 75 mg ODT for a qualifying migraine | Drug: Placebo<br>* DB Phase: matching placebo<br>Drug: Rimegepant<br>* OLE Phase: Rimegepant 75 mg ODT in association with each of the first 5 qualifying migraines<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Migraine headache pain relief will be assessed using the percentage of subjects with a headache pain intensity of none or mild. Migraine headache pain intensity will be measured on a 4-point numeric rating scale (0=none, 1=mild, 2=moderate, 3=severe). | 2 hours post-dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Migraine, Acute Migraine, Headache, Acute treatment of Migraine in adults unsuitable for triptans