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

Pfizer

Status and phase: Enrolling; Phase 4

Conditions: Migraine

Treatments: Drug: Rimegepant; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05509400

BHV3000-406

2022-001175-14 (EudraCT Number)

2024-513269-37-00 (Registry Identifier)

C4951004 (Other Identifier)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 600 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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600 participants in 2 patient groups, including a placebo group

Rimegepant

Experimental group

Description:

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)

Treatment:

Drug: Rimegepant

Drug: Rimegepant

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

Drug: Rimegepant

Drug: Rimegepant