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Daily pill aims to stop chronic migraine before it starts

NCT ID NCT07729462

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 27, 2026 · Last updated Sep 21, 2026 · Updated 4 times

Summary

This phase 3 trial tests whether taking rimegepant once daily can prevent migraine attacks in people with chronic migraine (15 or more headache days per month). About 400 adults will receive either rimegepant or a placebo for 12 weeks, then all participants may receive rimegepant for another 12 weeks. The study measures changes in monthly migraine days, medication use, and quality of life.

What this could mean

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

Active substance
a daily tablet of rimegepant, a CGRP receptor antagonist
What this could lead to
If successful, this could offer a new once-daily option to prevent chronic migraine attacks, reducing headache days and improving quality of life.
What could go wrong
This is a phase 3 trial, so earlier results may not hold up. Rimegepant is already approved for episodic migraine, but its effectiveness and safety for chronic migraine are still being tested.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 400 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2026

Expected to finish

Jan 2029

An estimate. End dates often move.

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.

Inclusion Criteria: * Male or female participants ≥18 years of age. * Diagnosis of chronic migraine, with or without aura, according to International Classification of Headache Disorders, 3rd edition (ICHD-3) criteria. * History of migraine for at least 1 year before screening. * Migraine onset before 50 years of age and chronic migraine onset before 65 years of age. * Migraine attacks lasting 4 to 72 hours when untreated or unsuccessfully treated. * During the 3 months prior to screening, an average of: * ≥15 monthly headache days (MHDs), * including ≥8 monthly migraine days (MMDs), * and ≥1 non-headache day per month. * Completion of the Observation Phase and fulfillment of all protocol-defined eligibility requirements prior to randomization. * Willing and able to comply with study procedures, including completion of the electronic diary. Exclusion Criteria: * Prior use of rimegepant for migraine prevention. * History of treatment failure of: * 2 gepants, or * 2 CGRP-targeting biologics, or * 1 gepant and ≥1 CGRP-targeting biologic. * Failure of \>4 migraine preventive medications, including at least 2 with different mechanisms of action. * Any medical or psychiatric condition, or clinically significant laboratory abnormality, that in the investigator's judgment may increase risk to the participant or interfere with study participation or interpretation of results. This includes, but is not limited to, uncontrolled hypertension or a history of Raynaud's phenomenon. * Pregnant, breastfeeding, planning to become pregnant, or planning to initiate breastfeeding during the study. * Positive amphetamine screening result unless attributable to prescribed stimulant therapy that has been stable for at least 3 months prior to Visit 1 and is expected to remain stable throughout study participation. * Use of investigational products or participation in another clinical study within protocol-defined exclusion windows. * Any other condition that, in the opinion of the investigator or sponsor, would make study participation unsafe or compromise study conduct.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    4 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Austin Clinical Trial Partners

    NOT_YET_RECRUITING

    Austin, Texas, 78737, United States

  • Hope Clinical Research

    RECRUITING

    Canoga Park, California, 91303, United States

  • Neurology Offices of South Florida PLLC

    RECRUITING

    Boca Raton, Florida, 33428, United States

  • Papillion Research Center / Avacare

    NOT_YET_RECRUITING

    Papillion, Nebraska, 68046, United States