RightFit
RecruitingPhase 3

A Study to Learn About the Study Medicine Called Rimegepant in Adults When Used for the Prevention of Chronic Migraine

AN INTERVENTIONAL EFFICACY AND SAFETY, PHASE 3, DOUBLE-BLIND, RANDOMIZED, 2-ARM STUDY TO INVESTIGATE THE PREVENTION OF CHRONIC MIGRAINE WITH RIMEGEPANT COMPARED WITH PLACEBO IN PARTICIPANTS 18 YEARS OF AGE OR OLDER

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Heart tracing (ECG)

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Safety evaluations will include monitoring of adverse events, clinical laboratory assessments, vital signs, electrocardiograms, and other protocol-defined safety measures."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether taking rimegepant once a day prevents more migraine days than a placebo, a pill with no active medicine. It is for adults with chronic migraine, meaning frequent headaches and migraines, and a migraine history of at least 1 year. The study lasts about 32 weeks.

Rimegepant is a calcitonin gene-related peptide (CGRP) receptor antagonist approved for the acute treatment of migraine attacks in adults and for the preventive treatment of episodic migraine in adults when administered every other day. This study evaluates once daily rimegepant for the preventive treatment of chronic migraine. After a 28-day observation period without study intervention, eligible participants will be randomized in a 1:1 ratio to receive either rimegepant 75 mg orally disintegrating tablet (ODT) or matching placebo once daily for 12 weeks under double-blind conditions. Participants who remain eligible at the end of the double-blind treatment phase will enter a 12-week open-label treatment period, during which all participants will receive open-label rimegepant 75 mg once daily. During this period, participants may also take an additional rimegepant tablet for the acute treatment of breakthrough migraine attacks, up to 10 doses per month. A 28-day follow-up period completes the approximately 32-week study. The primary objective of the study is to determine whether once-daily rimegepant is more effective than placebo in reducing monthly migraine days relative to the observation period in adults with chronic migraine. Secondary objectives include evaluating differences between rimegepant and placebo in migraine responder rates, headache severity, acute migraine medication use, quality of life, work productivity, cognitive functioning, and safety and tolerability. Approximately 400 adults aged 18 years or older with a diagnosis of chronic migraine for at least 1 year will be enrolled at multiple study sites.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 18 or older.
  • You have chronic migraine diagnosed using standard medical rules, with or without aura (warning signs such as changes in vision).
  • You have had migraines for at least 1 year.
  • Your migraines started before age 50, and your chronic migraine started before age 65.
  • Your migraine attacks last 4 to 72 hours without treatment or when treatment does not work.
  • Over the past 3 months, you averaged at least 15 headache days per month, including at least 8 migraine days, and at least 1 headache-free day.
  • You complete the 28-day observation period and meet all study rules before being assigned a treatment.
  • You are willing and able to follow study steps, including filling out an electronic diary.

Who can't join

  • You have used rimegepant to prevent migraines.
  • These migraine treatments did not work for you: 2 gepants, 2 CGRP-targeting biologics, or 1 gepant and at least 1 CGRP-targeting biologic. These are types of medicines that block a signal involved in migraine.
  • More than 4 migraine prevention medicines did not work for you, including at least 2 that work in different ways.
  • You have a medical or mental health condition, or an important abnormal lab result, that the study doctor thinks could raise your risk or affect the study. Examples include uncontrolled high blood pressure or a history of Raynaud's, which reduces blood flow to fingers or toes.
  • You are pregnant, breastfeeding, or planning to become pregnant or start breastfeeding during the study.
  • You test positive for amphetamines, unless this is from a prescribed stimulant with treatment stable for at least 3 months before the first visit and expected to stay stable during the study.
  • You used an experimental treatment or joined another clinical study within the time limits set by this study.
  • The study doctor or sponsor believes another condition would make participation unsafe or interfere with the study.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (19)

AZ

CA

FL

IN

KS

MA

MI

MO

NE

NY

OK

TN

TX

UT