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

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 for migraine prophylaxis in adults with a history of inadequate response to oral preventive medications

Key facts

Study ID

NCT05518123

Run by

Pfizer

People needed

962

Starts

2022-11-07

Expected to finish

2025-07-08

Last updated by the study team

2026-05-22

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 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.
• 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).

You may not qualify if…

• History of cluster headaches, basilar migraine (migraine with brainstem aura), or hemiplegic migraine.
• Current medication overuse headaches.
• 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.
• Inadequate response (due to lack of efficacy, prior intolerance, or contraindication) to agents across > 4 categories of recognized, orally administered, migraine-preventive medications.
• 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

• 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
• Michigan Headache & Neurological Institute — Ann Arbor, Michigan, United States
• Rochester Medical Group — Rochester Hills, Michigan, United States
• Clinvest Research, LLC — Springfield, Missouri, United States
• St Charles Clinical Research — Weldon Spring, Missouri, United States
• Wr-Crcn, Llc — Las Vegas, Nevada, United States
• Albuquerque Clinical Trials. Inc. — Albuquerque, New Mexico, United States
• DiGiovanna Institute for Medical Education And Research — North Massapequa, New York, United States
• Headache Wellness Center, PC — Greensboro, North Carolina, United States
• Synexus Clinical Research US, Inc. - Anderson — Anderson, South Carolina, United States
• Alliance for Multispecialty Reseach, LLC — Knoxville, Tennessee, 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 Sunshine Coast — Sippy Downs, Queensland, Australia
• Clinstile, SA de CV — Mexico City, Mexico

Full record on ClinicalTrials.gov

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