Daily pill aims to stop chronic migraine before it starts
NCT ID NCT07729462
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 Hide 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Preventive treatment of migraine are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
-
The places running it
4 sites. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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_RECRUITINGAustin, Texas, 78737, United States
-
Hope Clinical Research
RECRUITINGCanoga Park, California, 91303, United States
-
Neurology Offices of South Florida PLLC
RECRUITINGBoca Raton, Florida, 33428, United States
-
Papillion Research Center / Avacare
NOT_YET_RECRUITINGPapillion, Nebraska, 68046, United States