A Study to Learn About the Study Medicine Called Rimegepant in Women When Used for Intermittent Prevention of Menstrual Migraine
Key facts
- Where
- Bologna, Florence, L'aquila, Milan, Pavia, and Rome, ItalySee the 7 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 45 years old?
Source: NCT06641466, who can take part
Where in Italy
- Azienda Unita Sanitaria Locale Di BolognaBologna, ItalyNo longer taking part
- Azienda Ospedaliero-Universitaria CareggiFlorence, ItalyNo longer taking part
- Azienda Sanitaria Locale Avezzano Sulmona L'AquilaL'aquila, ItalyNo longer taking part
- Ospedale San Raffaele S.r.l.Milan, ItalyNo longer taking part
- Fondazione Istituto Neurologico Nazionale Casimiro MondinoPavia, ItalyNo longer taking part
- Fondazione Policlinico Universitario Campus Bio-medico In Forma A Bbreviata FonRome, ItalyNo longer taking part
- Irccs San Raffaele Roma S.r.l.Rome, ItalyNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Pfizer
- Trial code
- NCT06641466EU 2024-517121-10-00
- Record updated
- 9 July 2026
- Original description
The purpose of this study is to evaluate the efficacy and safety of rimegepant when administered during the peri-menstrual period (PMP) for intermittent prevention of migraine in women who experience menstrual migraine attacks.Read full original descriptionShow less
AN INTERVENTIONAL EFFICACY AND SAFETY, PHASE 3, DOUBLE-BLIND, PARALLEL GROUP STUDY TO INVESTIGATE INTERMITTENT PREVENTION OF MENSTRUAL MIGRAINE WITH RIMEGEPANT COMPARED WITH PLACEBO IN WOMEN PARTICIPANTS 18 TO 45 YEARS OF AGE
The purpose of this study is to evaluate the efficacy and safety of rimegepant when administered during the peri-menstrual period (PMP) for intermittent prevention of migraine in women who experience menstrual migraine attacks.
Inclusion: Participant has regular menstrual cycles ≥24 days and ≤34 days; A minimum 1-year history of migraine (with or without aura) consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd Edition; A history of menstrual migraine attacks of at least 3 months; Participant reported history of experiencing at least 1 migraine attack during the perimenstrual period in at least 2 out of 3 menstrual cycles immediately prior to screening; If the participant is receiving a permitted background continuous prophylactic migraine medication, the medication dose must be stable for at least 3 months prior to the Screening visit and, the dose is not expected to change during the course of the study.
Exclusion: Greater than 6 migraine days per month that are outside of the perimenstrual period in the 3 months prior to Screening; A diagnosis of chronic migraine or a history of more than 14 headache days per month on average, in the 3 months prior to Screening; History of retinal migraine, basilar migraine or hemiplegic migraine; Current diagnosis of schizophrenia, bipolar, or borderline personality disorder; Other pain syndromes (eg, fibromyalgia, complex regional pain syndrome), or significant neurological disorders (other than migraine), or other medical conditions (including endocrine and gynecological eg, severe dysmenorrhea.