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

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What is this study about?

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.

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 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 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 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 Study?

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 Study?

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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Azienda Ospedaliero Universitaria Careggi	Florence	Italy
Niepubliczny Zaklad Opieki Zdrowotnej Neuromed M. I M. Nastaj. sp.p.	Lublin	Poland
Futuremeds Sp. z o.o.	Wroclaw	Poland

Other Sites

Site Name	City	Country
Fondazione Istituto Neurologico Nazionale Casimiro Mondino	Pavia	Italy
Isala Klinieken Stichting	Zwolle	The Netherlands
Canisius Wilhelmina Ziekenhuis	Nijmegen	The Netherlands
Hospital Clinico Universitario Lozano Blesa	Zaragoza	Spain
Silmedic Sp. z o.o.	Katowice	Poland
Specjalistyczne Gabinety Sp. z o.o.	Cracow	Poland
Virgen del Rocío University Hospital	Sevilla	Spain
Ospedale San Raffaele S.r.l.	Milan	Italy
Azienda Unita Sanitaria Locale Di Bologna	Bologna	Italy
Universita’ Campus Bio-medico Di Roma	Rome	Italy
Hospital Clinic De Barcelona	Barcelona	Spain
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Irccs San Raffaele Roma S.r.l.	Rome	Italy
Centrum Leczenia MIGRE	Wroclaw	Poland
Klinische Forschung Schwerin GmbH	Schwerin	Germany
Indywidualna Praktyka Lekarska dr hab. med. Anna Szczepanska-Szerej	Lublin	Poland
Neurologie Berlin	Berlin	Germany
Lqcnl Uxrxmxhsavzc Mqdxoho Czdkkzl (gdzhh	Leiden	The Netherlands
Hcatgpre Umnxtwafpvgdv Dl Le Pxpnmvte	Madrid	Spain
Hitxwjvg Uacygaalfifwa Mppkqjd Da Vrtsfmeeoc	Santander	Spain
Afyupas Shvkkmsph Logpwr Alfgdsad Siqipuz Lfclnedxkvsnmc	L'aquila	Italy
Db Sldedkbh Lxpepxsl Bkke	Warsaw	Poland
Rguosq Mzdjsuvfmjp	Viborg	Denmark
Rdmmfvlortmbfc	Glostrup	Denmark
Fppgntoqn Pcjz Lg Ipqtpicojwwzb Bsubvgvxx Dng Hiauhexd Uibpxctuohyzk Lt Pdr	Madrid	Spain
Hriejxqj Vupt dlfnxyem	Barcelona	Spain
Ikomqroa Zvpwwro Dr Bzmvjiutxpuxkqtfs	Oświęcim	Poland
Fzrtjnalxr Geuw	Offenbach Am Main	Germany

Trial status

Country	Status	Recruitment Start
Denmark	Recruiting	05.09.2025
Germany	Recruiting	05.09.2025
Italy	Recruiting	05.09.2025
Poland	Recruiting	05.09.2025
Spain	Recruiting	05.09.2025
The Netherlands	Recruiting	05.09.2025

Trial locations

Investigated drugs:

Rimegepant

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.

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 ID:

2024-517121-10-00

Protocol code:

C4951063

NCT ID:

NCT06641466

Trial Phase:

Therapeutic confirmatory (Phase III)

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

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