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Efficacy and Tolerability of Rimegepant for the Prevention of Migraine in Adults With History of Inadequate Response to Oral Preventive Medications | Clinical Trials | Clareo Health

COMPLETEDPHASE4

Efficacy and Tolerability of Rimegepant for the Prevention of Migraine in Adults With History of Inadequate Response to Oral Preventive Medications

A Phase 4, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Tolerability of Rimegepant for the Prevention of Migraine in Adults With a History of Inadequate Response to Oral Preventive Medications

NCT05518123•Pfizer

View on ClinicalTrials.gov

Summary

This study is being conducted to evaluate the efficacy and tolerability of rimegepant for migraine prophylaxis in adults with a history of inadequate response to oral preventive medications

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Migraine attacks present for more than 1 year with the age of onset prior to 50 years of age.
•2. Migraine attacks, on average, lasting about 4 - 72 hours, if untreated.
•3. 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).
•4. Less than15 headache days (migraine or non-migraine) per month in each of the 3-months prior to the Screening Visit and throughout the Screening Phase.
•5. Subjects must be able to distinguish migraine attacks from tension/cluster headaches. Prior inadequate response, within 10 years of the Screening Visit, to agents across 2-4 categories of recognized, orally-administered, migraine-preventive medications where at least one example of prior inadequate response is due to lack of efficacy or prior intolerance (not contraindication).

Exclusion Criteria

•1. History of cluster headaches, basilar migraine (migraine with brainstem aura), or hemiplegic migraine.
•2. Current medication overuse headaches.
•3. 15 or more headache days (migraine or non-migraine) per month in any of the 3-months prior to the Screening Visit or during the first 28- days of the Observation Phase.
•4. Inadequate response (due to lack of efficacy, prior intolerance, or contraindication) to agents across \> 4 categories of recognized, orally administered, migraine-preventive medications.
•5. Active chronic pain syndrome (such as fibromyalgia, chronic pelvic pain, complex regional pain syndrome \[CRPS\]).
•6. 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.

Locations (111)

Clinical Research Institute

Los Angeles, California, United States

California Neuroscience Research, LLC

Sherman Oaks, California, United States

Ki Health Partners LLC, dba New England Institute for Clinical Research

Stamford, Connecticut, United States

Sandhill Research, LLC d/b/a Accel Research Sites Network-Edgewater Clinical Research Unit

Edgewater, Florida, United States

Wr-Msra,Llc

Lake City, Florida, United States

AppleMed Research Group, LLC

Miami, 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

Boston Clinical Trials

Boston, Massachusetts, United States

Community Clinical Research Network, Inc.

Marlborough, Massachusetts, United States

Key Dates

Start Date

November 7, 2022

Primary Completion Date

March 31, 2025

Completion Date

July 8, 2025

Last Updated

July 18, 2025

Enrollment

658

ACTUAL participants

Conditions

Migraine

Interventions

Rimegepant

DRUG

Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 18, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Efficacy and Tolerability of Rimegepant for the Prevention of Migraine in Adults With History of Inadequate Response to Oral Preventive Medications

Inclusion Criteria

Exclusion Criteria

A Study to Learn About the Study Medicine Called Rimegepant in Women When Used for Intermittent Prevention of Menstrual Migraine

A Clinical Trial to Evaluate Efficacy and Safety of Xeomin® Injections for Preventing Chronic Migraine

Mind Body Balance for Pediatric Migraine

Light Exposure, Migraine Outcomes, and Sleep Quality

A Study to Learn About the Study Medicine Called Rimegepant in Adolescents With Frequent Migraine

Prophylactic Treatment With Atorvastatin for Episodic Migraine.