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

Completed · Phase 4 · Has a placebo group

Conditions studied: Migraine

In brief

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).

Key facts

Study ID

NCT05509400

Run by

Pfizer

People needed

813

Starts

2022-10-18

Expected to finish

2025-06-10

Last updated by the study team

2026-04-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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
• Community Clinical Research Network Inc — Marlborough, Massachusetts, United States
• Michigan Headache & Neurological Institute — Ann Arbor, Michigan, United States
• Rochester Medical Group — Rochester Hills, Michigan, United States
• DM Clinical Research - Detroit — Southfield, Michigan, United States
• Clinvest Research, LLC — Springfield, Missouri, United States
• St Charles Clinical Research — Weldon Spring, Missouri, United States
• DM Clinical Research - NY, NY — Brooklyn, New York, United States
• New York Neurology Associates — New York, New York, United States
• Montefiore Medical Center — The Bronx, New York, United States
• Headache Wellness Center, PC — Greensboro, North Carolina, United States
• Synexus Clinical Research US, Inc. - Anderson — Anderson, South Carolina, United States
• Red Star Research, LLC — Lake Jackson, Texas, United States
• DM Clinical Research — Tomball, Texas, United States
• Northwest Clinical Research Center — Bellevue, Washington, United States
• USC Clinical Trials Centre — Sippy Downs, Queensland, Australia
• Alfred Hospital — Melbourne, Victoria, Australia
• Clinical Research Institute — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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