Efficacy and Safety Study of Rimegepant in Episodic Migraine Prevention With Multiple Dosing Regimens

Completed · Phase 4 · Has a placebo group

Conditions studied: Migraine

In brief

The purpose of this study is to compare the efficacy and safety of daily and every other day dosing of rimegepant to placebo as a preventive treatment for episodic migraine.

Key facts

Study ID

NCT05217927

Run by

Pfizer

People needed

1415

Starts

2022-03-04

Expected to finish

2024-12-11

Last updated by the study team

2025-12-16

Who can join

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

You may qualify if…

• Target Population: Subject has at least 1 year history of episodic migraine (with or without aura) consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd Edition, including the following:
• Age of onset of migraines prior to 50 years of age
• Migraine attacks, on average, lasting 4-72 hours if untreated
• Per subject report, 4-14 migraine attacks per month within the last 3 months prior to the Screening Visit (month is defined as 4 weeks for the purpose of this protocol

You may not qualify if…

• Sex and Reproductive Status:
• WOCBP who are unwilling or unable to use an acceptable contraceptive method or abstinence to avoid pregnancy for the entire study and for 60 days after the last dose of study drug
• Women who are pregnant or breastfeeding
• Women with a positive pregnancy test at screening or prior to study drug administration
• Prohibited Medications:
• Use of prophylactic migraine medication within 30 days prior to the Screening Visit.
• History of use of analgesics (e.g., non-steroidal anti-inflammatory drugs [NSAIDs] or acetaminophen) on ≥ 15 days per month during the 3 months (12 weeks) prior to the Screening Visit.
• Use of medication accepted for treatment of acute migraine for a nonmigraine indication on ≥ 15 days per month during the 3 months (12 weeks) prior to the Screening Visit.
• Subjects who previously discontinued biologic migraine medication must have done so at least 6 months (24 weeks) prior to the Screening Visit.
• Subjects taking a prohibited medication as defined per protocol

Where it is running

• Dent Neurosciences Research Center, Inc. — Amherst, New York, United States
• Montefiore Medical Center — The Bronx, New York, United States
• Upstate Clinical Research Associates, LLC — Williamsville, New York, United States
• Wellnow Urgent Care and Research — Columbus, Ohio, United States
• Hometown Urgent Care and Research — Huber Heights, Ohio, United States
• Velocity Clinical Research, Medford — Medford, Oregon, United States
• Preferred Primary Care Physicians, Inc. — Pittsburgh, Pennsylvania, United States
• Velocity Clinical Research - Providence — East Greenwich, Rhode Island, United States
• Velocity Clinical Research - Columbia — Columbia, South Carolina, United States
• Velocity Clinical Research, Gaffney — Gaffney, South Carolina, United States
• Tribe Clinical Research LLC — Greenville, South Carolina, United States
• Clinical Research Associates, Inc. — Nashville, Tennessee, United States
• FutureSearch Trials of Neurology — Austin, Texas, United States
• FutureSearch Trials of Dallas, LP — Dallas, Texas, United States
• Texas Center for Drug Development, Inc. — Houston, Texas, United States
• APD Clinical Research — Magnolia, Texas, United States
• Wasatch Clinical Research , LLC(Administrative Location) — Salt Lake City, Utah, United States
• Seattle Clinical Research Center — Seattle, Washington, United States
• Medizinische Universitat Innsbruck — Innsbruck, Tyrol, Austria
• Christian-Doppler-Klinik — Salzburg, Austria
• Calgary Headache & Assessment Management Program (CHAMP) — Calgary, Alberta, Canada
• OCT Research ULC — Kelowna, British Columbia, Canada
• James K. Lai MD Inc. — Vancouver, British Columbia, Canada
• Centricity Research — Halifax, Nova Scotia, Canada
• Alliance for Multispecialty Research, LLC — Las Vegas, Nevada, United States

Full record on ClinicalTrials.gov

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