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

Phase 4

Completed

• Conditions: Migraine
• Interventions: Drug: Placebo; Drug: Rimegepant

• Registration Number: NCT05509400
• Lead Sponsor: Pfizer

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).

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 Timeline

• Study First Submitted: 2022-08-18
• Study First Submitted QC: 2022-08-18
• Study First Posted: 2022-08-22
• Study Start: 2022-10-18
• Primary Completion: 2025-03-10
• Study Completion: 2025-06-10
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-16
• Last Update Posted: 2025-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 632

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Placebo	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
Placebo	Rimegepant	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
Rimegepant	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)

Primary Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (93)

AOU Policlinico di Modena; 🇮🇹 Modena, Italy

Clinical Research Institute; 🇺🇸 Los Angeles, California, United States

Ki Health Partners LLC, dba New England Institute for Clinical Research; 🇺🇸 Stamford, Connecticut, United States

Wr-Msra, Llc; 🇺🇸 Lake City, Florida, United States

Sensible Healthcare LLC; 🇺🇸 Ocoee, Florida, United States

Sandhill Research, LLC d/b/a Accel Research Sites Network - Ormond Clinical Research Unit; 🇺🇸 Ormond Beach, Florida, United States

WR-Mount Vernon Clinical Research, LLC; 🇺🇸 Sandy Springs, Georgia, United States

Collective Medical Research; 🇺🇸 Overland Park, Kansas, United States

DelRicht Research; 🇺🇸 New Orleans, Louisiana, United States

Boston Clinical Trials; 🇺🇸 Boston, Massachusetts, United States

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