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

• Sponsor: Biohaven Pharmaceuticals, Inc. (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05509400
• Collaborator: (none)
• Enrollment: 600
• Arms: 2
• Anticipated Duration (Months): 22

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Migraine	Drug: Rimegepant; Drug: Placebo; Drug: Rimegepant	Phase 4

Detailed Description

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 600 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: 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
• Anticipated Study Start Date: Oct 1, 2022
• Anticipated Primary Completion Date: Apr 1, 2024
• Anticipated Study Completion Date: Aug 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Rimegepant 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; DB Phase: Rimegepant 75 mg Orally Disintegrating Tablet (ODT); Drug: Rimegepant; OLE Phase: Rimegepant 75 mg ODT in association with each of the first 5 qualifying migraines
Placebo Comparator: Placebo 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; DB Phase: matching placebo; Drug: Rimegepant; OLE Phase: Rimegepant 75 mg ODT in association with each of the first 5 qualifying migraines

Outcome Measures

Primary Outcome Measures

1. 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. [2 hours post-dose]

   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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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:

1. History of cluster headache, basilar migraine, or hemiplegic migraine

2. Current medication overuse headaches

3. Headaches occurring 15 or more days per month (migraine or non-migraine) in any of the 3 months prior to the Screening Visit

4. Active chronic pain syndrome (such as fibromyalgia, chronic pelvic pain, complex regional pain syndrome [CRPS])

5. 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Biohaven Pharmaceuticals, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Biohaven Pharmaceuticals, Inc.
• ClinicalTrials.gov Identifier: NCT05509400
• Other Study ID Numbers: BHV3000-406; 2022-001175-14
• First Posted: Aug 22, 2022
• Last Update Posted: Aug 22, 2022
• Last Verified: Aug 1, 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Biohaven Pharmaceuticals, Inc.: Migraine; Acute Migraine; Headache; Acute treatment of Migraine in adults unsuitable for triptans
• Additional relevant MeSH terms: Migraine Disorders

Study Results

No Results Posted as of Aug 22, 2022