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Study of Rimegepant for Prevention of Menstrual Migraine in Women Aged 18-45 Years

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on menstrual migraine, a specific type of headache that occurs in women during their menstrual cycle. The research evaluates a medication called rimegepant (VYDURA), which is taken as an oral dissolving tablet to prevent migraine attacks that happen around menstruation. The study compares the effectiveness of rimegepant with placebo in preventing these headaches.

The study examines whether taking rimegepant for 7 days during each menstrual cycle can reduce the number of migraine days that women experience during their periods. The medication is given as a 75 mg dissolving tablet that is taken by mouth. Women participating in the study will receive either rimegepant or placebo during multiple menstrual cycles.

The treatment aims to decrease both the frequency and severity of menstrual migraine attacks. During the study, participants will need to track their migraine days, headache intensity, and use of other migraine medications. The study will monitor how the treatment affects participants' daily activities and their ability to function during their menstrual periods.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial participation period

    You will enter an observation period to document your menstrual migraine patterns.

    During this time, you will need to track your migraine days using an electronic diary, particularly during the perimenstrual period (2 days before to 3 days after the start of menstruation).

  2. Step 2

    Treatment phase begins

    You will be randomly assigned to receive either VYDURA (75 mg oral dissolving tablet) or a placebo tablet.

    The treatment will be taken by mouth for 7 days during each menstrual cycle.

    Neither you nor your doctor will know which treatment you are receiving.

  3. Step 3

    Monthly monitoring

    You will continue to track your migraines using the electronic diary throughout each menstrual cycle.

    The diary will record information about your headache days, migraine severity, and use of any additional migraine medications.

    You will complete a MiCOAS (Migraine Clinical Outcome Assessment System) questionnaire to evaluate cognitive effects one day after each 7-day treatment period.

  4. Step 4

    Ongoing treatment cycles

    The treatment pattern will continue for multiple menstrual cycles until the study end date.

    If you are taking other allowed migraine prevention medication, the dose must remain stable throughout the study.

    Any oral contraceptives being used must maintain the same dosage throughout the study period.

Who can join the trial?

7 criteria

  • You must be a female between 18 and 45 years old
  • You must have regular menstrual cycles lasting between 24 and 34 days and be able to predict your period start date within 3 days
  • You must have at least a 1-year history of migraine (with or without warning signs called "aura") diagnosed by a doctor
  • You must have experienced menstrual migraines for at least 3 months, with at least one migraine occurring during your period or 2 days before it in at least 2 out of 3 menstrual cycles before screening
  • If you are taking any preventive migraine medication (except medications targeting CGRP, a protein involved in migraine), the dose must have remained unchanged for at least 3 months before screening and must stay the same during the study
  • If you use birth control pills, you must have been on the same dose for at least 2 months before screening and plan to stay on the same dose during the study
  • If you use an IUD (Intrauterine Device) for birth control, it must have been in place for at least 3 months before the study

Who cannot join the trial?

15 criteria

  • Age under 18 or over 50 years old
  • Male patients (study is for females only)
  • History of chronic migraine (15 or more headache days per month)
  • Current pregnancy or breastfeeding
  • Use of hormonal contraception or hormone replacement therapy
  • Irregular menstrual cycles (cycles shorter than 21 days or longer than 35 days)
  • History of significant medical conditions that could interfere with the study results
  • Current use of other migraine preventive medications
  • Known allergies or sensitivity to rimegepant or similar medications
  • Participation in another clinical trial within the past 30 days
  • History of substance abuse in the past 12 months
  • Uncontrolled psychiatric conditions
  • Inability to distinguish migraine headaches from other types of headaches
  • History of hemiplegic migraine (migraine with temporary paralysis)
  • Severe liver or kidney disease
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Investigated drugs

Rimegepant is a medication used to prevent and treat migraine headaches that occur around menstrual periods. It belongs to a class of drugs called CGRP receptor antagonists. This medication works by blocking specific proteins in the brain that are involved in causing migraine pain. It comes as an orally disintegrating tablet that dissolves in the mouth. The medication is taken before and during the menstrual period to help prevent migraine attacks from occurring. Placebo is also used in this trial as a comparison to test the effectiveness of Rimegepant.

What is already known about the treatment

Rimegepant - An orally disintegrating tablet (ODT) medication that belongs to the class of gepants, specifically designed for the prevention and treatment of migraine headaches. This medication works by blocking calcitonin gene-related peptide (CGRP) receptors in the brain, which play a crucial role in the development of migraine attacks. Currently approved by medical authorities, Rimegepant is particularly studied for its effectiveness in preventing menstrual migraine attacks when taken intermittently during the menstrual cycle. The medication represents a newer generation of migraine treatments that offers a targeted approach to migraine management without the cardiovascular side effects associated with older medications.

Investigated diseases

Menstrual Migraine - A specific type of migraine headache that occurs in connection with menstrual periods, typically starting before or during menstruation. These headaches usually appear during a five-day window around the start of menstruation, known as the perimenstrual period. The condition is characterized by throbbing head pain, often occurring on one side of the head, and may be accompanied by nausea, sensitivity to light and sound. Menstrual migraines tend to be more severe, longer-lasting, and more resistant to relief than non-menstrual migraines. These headaches are linked to hormonal changes, particularly the natural drop in estrogen levels that occurs before menstruation.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-517121-10-00Protocol codeC4951063Estimated enrolment470 patientsSponsorPfizer Inc.

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