RecruitingPHASE3INTERVENTIONAL

A Study to Learn About the Study Medicine Called Rimegepant in Women When Used for Intermittent Prevention of Menstrual Migraine

This research is investigating a new medicine called rimegepant. It's specifically for women who experience migraines that are linked to their menstrual cycle, often called menstrual migraines. The study aims to find out if taking rimegepant around the time of your period can help prevent these migraines from happening. Researchers also want to understand if the medicine is safe and well-tolerated. Some participants will receive rimegepant, others a dummy pill (placebo), or their usual treatment, allowing doctors to compare how effective and safe rimegepant is compared to these other options. The study is currently in its final stages, meaning it's being tested on a larger group of people.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Pfizer

Enrolment target

723

Start

11 Mar 2025

Estimated completion

30 Mar 2027

Menstrual Migraine

What is this study about?

This study is all about a new medicine called rimegepant. It's being tested to see if it can help women who suffer from a specific type of migraine known as 'menstrual migraines.' These are migraines that tend to occur around the time of a woman's period.

The main goal is to find out if taking rimegepant just before and during your period can prevent these migraines from striking. Researchers also want to make sure the medicine is safe and doesn't cause too many side effects. By comparing rimegepant to a dummy pill (placebo) and existing treatments, they can get a clear picture of how well it works and if it could be a helpful new option for managing menstrual migraines.

This kind of research is really important because menstrual migraines can be very disruptive to daily life. Finding new ways to prevent them could significantly improve the quality of life for many women. The study is in 'Phase 3,' which means it's a large study, often involving centers in different countries, and usually the last step before a medicine might be considered for wider use.

Key takeaways

Tests a new medicine (rimegepant) for menstrual migraines.
Aims to prevent migraines around your period.
Compares rimegepant to a dummy pill and usual care.
Open to women aged 18-45 with regular menstrual migraines.
Involves regular clinic visits and health checks.
You can leave the study at any time.

Who may be eligible?

This study is looking for women aged between 18 and 45 years old. To be considered, your menstrual cycles should be regular, lasting between 24 and 34 days. You should also have had migraines for at least a year, and specifically, have experienced menstrual migraines for at least three months. Importantly, you need to have had at least one migraine around your period in two out of the last three months.

There are also some reasons why you might not be able to join. For instance, if you experience more than six migraine days a month that are not related to your period, or if you've been diagnosed with chronic migraine (more than 14 headache days per month), this study might not be suitable for you. Certain types of migraines, like retinal, basilar, or hemiplegic migraines, would also mean you couldn't take part.

Finally, if you have certain other significant health conditions, such as some mental health diagnoses like schizophrenia or bipolar disorder, or other serious pain conditions, neurological disorders (apart from migraine itself), or severe gynaecological issues like very bad period pain, you wouldn't be able to participate. If you're on other migraine prevention medicine, your dose needs to have been stable for at least 3 months and not expected to change.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you a woman between 18 and 45 years old?
Do you have regular periods, every 24-34 days?
Have you had migraines for at least a year?
Do you get migraines consistently around your period (menstrual migraines)?
Have you had a migraine around your period in at least 2 of the last 3 months?
Do you have good overall health, without certain serious conditions?

Answer every question to see your result.

What does participation involve?

If you join this study, you could be asked to take one of three options: the study medicine (rimegepant), a dummy pill (placebo), or continue with your usual standard care. This is a "blinded" study, meaning neither you nor your study doctor will know which option you're receiving. This helps make sure the results are fair.

The study will involve several visits to the study clinic, where you'll have various health checks and assessments. You'll likely be asked to keep a record of your migraines and any symptoms you experience. The total duration of your involvement in the study will vary, but you'll be given a clear schedule. You'll also have follow-up appointments to monitor your health and how you're responding to the treatment.

Potential risks and benefits

Taking part in this study could potentially offer some benefits, such as helping to prevent your menstrual migraines or giving you access to a new treatment before it's widely available. You'll also receive careful monitoring of your health throughout the trial. However, there are potential risks, including side effects from the study medicine, which will be fully explained before you agree to participate. You might also receive a placebo, meaning you wouldn’t get active treatment for your migraines. It's very important to remember that participating is entirely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (122)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Mayo Clinic Hospital
Verified postcode
Phoenix, United States· Recruiting
Mayo Clinic Specialty Building
Verified postcode
Phoenix, United States· Recruiting
Mayo Clinic Arizona
Verified postcode
Scottsdale, United States· Recruiting
Hope Clinical Research, Inc.
Verified postcode
Canoga Park, United States· Recruiting
Axiom Research
Verified postcode
Colton, United States· Recruiting
Diablo Clinical Research, Inc.
Verified postcode
Walnut Creek, United States· Recruiting
VIN - Aventura
Verified postcode
Aventura, United States· Recruiting
Velocity Clinical Research, Hallandale Beach
Verified postcode
Hallandale, United States· Recruiting
Jacksonville Center for Clinical Research
Verified postcode
Jacksonville, United States· Recruiting
Urban Family Practice Associates
Verified postcode
Marietta, United States· Recruiting
Clinical Research Atlanta
Verified postcode
Stockbridge, United States· Recruiting
St Luke's Clinic - Neurology
Verified postcode
Meridian, United States· Recruiting

Common questions

What is rimegepant?

Rimegepant is a new medicine being studied to see if it can help prevent migraines, especially those that happen around your period.

What is a 'placebo'?

A placebo is a dummy pill that looks just like the study medicine but contains no active ingredients. It helps us compare the effects of the real medicine accurately.

Will I know if I'm getting the study medicine or the placebo?

No, in this study, neither you nor your doctor will know whether you are receiving rimegepant, the placebo, or your usual care. This is called a 'blinded' study.

What are 'menstrual migraines'?

Menstrual migraines are migraines that consistently occur just before, during, or just after your period.

Can I still take my regular migraine medication?

If you're already taking daily medication to prevent migraines, you might still be able to join, but your dose must have been stable for at least 3 months.

How to find out more

Pfizer CT.gov Call Center

clinicaltrials.gov_inquiries@pfizer.com 1-800-718-1021 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.