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Daily pill could keep migraines at bay

NCT ID NCT05207865

Disease control Sponsor: Pfizer Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study tested the safety of taking rimegepant every day to prevent episodic migraines. 441 adults with a history of migraines took a daily 75mg tablet for up to 52 weeks. Researchers tracked side effects and lab changes to see if long-term daily use is safe and tolerable.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
rimegepant (a daily pill for migraine prevention)
What this could lead to
If successful, this could confirm that taking rimegepant daily is a safe option to prevent migraines, reducing attack frequency.
What could go wrong
This is a completed Phase 4 safety study, not designed to prove how well it works. Side effects or lack of long-term benefit may limit use.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

441 people

The number who actually took part.

Started

Mar 2022

Finished

Jul 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: * 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) * Subjects ≥ 18 years Key Exclusion Criteria: * Subject history with current evidence of uncontrolled, unstable or recently diagnosed cardiovascular disease, such as ischemic heart disease, coronary artery vasospasm, and cerebral ischemia. Subjects with myocardial infarction (MI), acute coronary syndrome (ACS), percutaneous coronary intervention (PCI), cardiac surgery, stroke or transient ischemic attack (TIA) during the 6 months (24 weeks) prior to the Screening Visit. * Uncontrolled hypertension (high blood pressure) or uncontrolled diabetes. * The subject has a history or current evidence of any unstable medical conditions (e.g., history of congenital heart disease or arrhythmia, known or suspected infection, hepatitis B or C, or cancer) that, in the investigator's opinion, would expose them to undue risk of a significant adverse event (AE) or interfere with assessments of safety or efficacy during the course of the study * History of use of opioid- or barbiturate- (e.g. butalbital) containing medication for 4 or more days per month during the 3 months (12 weeks) prior to the Screening Visit * WOCBP who are unwilling or unable to use an acceptable contraceptive method or abstinence to avoid pregnancy for the entire study and for 28 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

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Conditions

The condition(s) this trial relates to.

hyperacusis migraine disorder Photophobia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Episodic migraine Migraine Phonophobia Photophobia

Contacts and locations

Locations

  • Advanced Investigative Medicine, Inc.

    Hawthorne, California, 90250, United States

  • Boston Clinical Trials

    Boston, Massachusetts, 02131, United States

  • CVS HealthHUB - Runnemede

    Runnemede, New Jersey, 08078, United States

  • CVS HealthHub - East Brunswick

    East Brunswick, New Jersey, 08816, United States

  • CVS HealthHub - Lawrenceville

    Lawrenceville, New Jersey, 08648, United States

  • Chase Medical Research, LLC

    Waterbury, Connecticut, 06708, United States

  • Clinical Research Philadelphia, LLC

    Philadelphia, Pennsylvania, 19114, United States

  • Elite Clinical Studies, LLC

    Phoenix, Arizona, 85018, United States

  • Michigan Head Pain & Neurological Institute

    Ann Arbor, Michigan, 48104, United States

  • OK Clinical Research, LLC

    Edmond, Oklahoma, 73034, United States

  • Phoenix Medical Research, LLC

    Miami, Florida, 33165, United States

  • SPRI Clinical Trials, LLC

    Brooklyn, New York, 11235, United States

  • The Headache Clinic

    Alexandria, Louisiana, 71301, United States

  • Tidewater Integrated Medical Research

    Virginia Beach, Virginia, 23454, United States

  • VIP Trails

    San Antonio, Texas, 78230, United States

  • VIP Trials

    San Antonio, Texas, 78230, United States

  • Velocity Clinical Research

    Cincinnati, Ohio, 45242, United States

  • Velocity Clinical Research - North Hollywood

    North Hollywood, California, 91606, United States

  • WR-ClinSearch, LLC

    Chattanooga, Tennessee, 37421, United States

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