The medicine being studied in this clinical trial is an orally disintegrating tablet (dissolves in your mouth) developed by Pfizer called rimegepant. It has not previously been studied for the treatment or prevention of menstrual migraines.
If menstrual migraines are interrupting your life every month, learn more about a Pfizer clinical trial for a potential preventive medicine.
Menstrual migraines are a type of headache caused by hormone fluctuations that occur right before or during your menstrual period. They are often more severe than other types of headaches and can have a significant impact on your daily life and well-being.
This clinical trial will help us learn if taking an oral medicine for 7 days each month can help prevent menstrual migraines in women who are 18 to 45 years of age.
Who may participate
Joining a clinical trial is an important and personal decision. Thank you for considering participation.
This clinical trial may be an option if you:
- Are 18 to 45 years of age
- Have regular and predictable menstrual cycles that are 24 to 34 days in length
- Have had migraines for at least 1 year and have had a menstrual migraine (occurring just before or during your menstrual period) in at least 2 of your last 3 menstrual cycles
- Do not have more than 14 migraine days per month
- Do not have more than 6 migraine days per month when you are not on your menstrual period
There are other requirements for taking part in this clinical trial. The team will explain these to you if you’d like to learn more. To see if you may qualify, click “Get Started.”
Condition
Menstrual migraine
Age
18-45 years
Sex
Female
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.
Get started — See if you may be eligible
Answer a 2-minute questionnaire.
A first step as you consider this study is to answer a 2-minute online questionnaire about your health and medical history. You will also be asked to provide your zip code, which may be used by Pfizer, and our partners working on this study to help improve the study recruitment process. If your answers show the study might be a good fit for you, you may choose to have your contact information shared with a Pfizer Clinical Trial Contact Center Navigator.
Speak with a study representative.
If you’re interested, a Pfizer Clinical Trial Contact Center Navigator will call you and do a more detailed review of the study and your medical history to see if you may be able to participate and be referred to a study clinic that you select.
Confirm your eligibility.
Your answers to these questions will only be linked to you if your responses indicate that you may be eligible to participate in this study and you choose to share your contact information with the study team. Pfizer study team members and our partners will have access to reports containing aggregated data that will not be directly linked back to you. Only the study staff can determine if you meet the study’s eligibility criteria and are able to enroll in the study.
What to expect
If this clinical trial is a good fit for you and you decide to take part, you will be randomly assigned (like flipping a coin) to receive the study medicine or placebo. The placebo looks just like the study medicine but does not contain any active ingredients. You will not know what you have been assigned to receive.
You will take the study medicine or placebo by mouth once daily for 7 days each month beginning 3 days before you expect to start your menstrual period.
After 5 menstrual cycles, you may have the option to continue in an open-label treatment phase. During this phase, all participants will receive the study medicine.
Length of study treatment
Up to 8 months (7 days each month)
Number of study visits
About 10 visits
Long-term follow up
About 28 days
About the study medicine
About the study medicine
Participation matters
Participation matters
It’s important that all women who experience menstrual migraines have treatment options that work for them. Ensuring diversity within clinical trials enables us to see how potential treatments work in different people. We’ll be looking at factors like age and ethnicity to see if the study medicine is effective for everyone.
Frequently asked questions
Is there a cost to participate?
There is no cost to participate. You will also be compensated for completing clinical trial activities.
What if I change my mind?
Participating in a clinical trial is your choice. You can choose to leave the clinical trial at any time, for any reason, and your regular medical care will not be affected.
Will I receive the study medicine?
Initially, you will have a 50/50 chance (like flipping a coin) of receiving the study medicine or placebo. After about 5 months, you will have the option to receive the study medicine for 3 menstrual cycles in an open-label extension period (no chance of placebo).
What if I get a migraine during the clinical trial?
You may take permitted medications as needed to treat any migraines that occur during your time in the clinical trial. The team will discuss treatment options with you in more detail.
