Preventive Treatment of Migraine study: Rimegepant
Official title A Study to Learn About the Study Medicine Called Rimegepant in Adults When Used for the Prevention of Chronic Migraine
ClinicalTrials.gov ID: NCT07729462
What this study is testing
What is Rimegepant?
an investigational daily oral tablet being studied for the preventive treatment of chronic migraine is designed to block the calcitonin gene‑related peptide (CGRP) receptor, which is involved in migraine pathways
Also referred to as Nurtec ODT.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether taking rimegepant every day works better than a pretend pill. It looks at how well it reduces the number of days you have migraines.
- Who it's for
- You may be able to join if you are an adult with chronic migraine that has lasted at least one year.
- What's involved
- You would take a pill by mouth once a day for 12 weeks. You might get the real medicine or a pretend one, and neither you nor the team knows which.
- Time commitment
- The study lasts about 32 weeks and includes a 28-day start period and later check-ins.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
You likely can't join if
- Prior use of rimegepant for migraine prevention.
- 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...
See the full eligibility 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.
- ≥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.
- Prior use of rimegepant for migraine prevention.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Scottsdale, Arizona, United States
- Canoga Park, California, United States
- Fresno, California, United States
- Los Angeles, California, United States
- Boca Raton, Florida, United States
- Winter Park, Florida, United States
- Indianapolis, Indiana, United States
- Overland Park, Kansas, United States
- Ann Arbor, Michigan, United States
- City of Saint Peters, Missouri, United States
- Papillion, Nebraska, United States
- Oklahoma City, Oklahoma, United States
- Memphis, Tennessee, United States
- Austin, Texas, United States
- Dallas, Texas, United States
- Jerusalem, Jerusalem, Israel
- Tel Aviv, Israel
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Scottsdale, Arizona, United States; Canoga Park, California, United States; Fresno, California, United States; Los Angeles, California, United States; Boca Raton, Florida, United States; Winter Park, Florida, United States and 11 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.