A new clinical trial researching a potential daily treatment for chronic migraine
Who may participate
You might be able to take part in this trial if you:
- Are 18 years of age or older
- Have experienced migraine attacks for at least 1 year
- Have migraines that last about 4 to 72 hours if untreated or unsuccessfully treated
- Have had at least 15 headache days each month for the last 3 months on average
There are other requirements that the study team will discuss with you.
Each clinical study has its own guidelines for who can participate, called eligibility criteria. However, only the research study staff can determine if you qualify to enroll in the study.
What to expect
This study is exploring whether taking rimegepant every day is safe and can help reduce the number of migraine days compared to taking a placebo (which looks like rimegepant but has no medicine in it).
Rimegepant is part of a group of migraine medicines called CGRP receptor antagonists. It’s a quick-dissolving tablet and is currently approved for people to take a maximum of 1 dose every other day to help prevent migraine attacks.
This clinical trial consists of a 4-week Observational Phase, a 12-week Double-blind Phase, a 12-week Open-label Phase, and a Follow-up Phase 4 weeks after the last dose of study treatment.
During the Observation, Double-blind, and Open-label Phase, you will be given an electronic diary (eDiary) that you will need to complete every day. This may include information about your migraines or other headaches you experience.
The study treatment and any trial-related procedures will be provided at no cost. You may be paid back (reimbursed) for expenses you have due to taking part in the trial, such as travel or meals. Participants do not need health insurance to take part.
Tomorrow's breakthroughs start today with you
Representation in trial participants is important in order to understand how potential medicines work in different people. Race, ethnicity, age, and sex can all impact how people respond to the same treatment.
When you participate in a clinical trial, you're helping to represent both your community and all people who are affected by migraine. Your participation could make a difference.
Frequently asked questions
During migraine attacks, a protein called CGRP is released. CGRP attaches to receptors in the nerve cells of the brain causing inflammation and increased pain signals. Rimegepant works by blocking CGRP from attaching to these receptors, reducing the release of pain signals.
While all clinical trials come with some risks, participant safety is always the top priority. Clinical trials are reviewed and approved by committees responsible for protecting the rights and safety of all participants. These committees continue to regularly review the trial’s progress to ensure there are no unnecessary or excessive risks to participants.
The known and unknown risks of participating will be explained to you during the informed consent process that happens before you decide whether to participate.
At the beginning and throughout this clinical trial, the study doctor will ask about your medical history, including any previous and current medications you are taking. You will have a physical exam, vital signs, ECG, and blood and urine tests done. The study team will give you more information about the tests and procedures during the review of the informed consent document (ICD).
Taking part in this clinical trial is your choice. You can choose to leave the clinical trial at any time, for any reason.
