Recruiting NCT06641466
A Study to Learn About the Study Medicine Called Rimegepant in Women When Used for Intermittent Prevention of Menstrual Migraine
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Rimegepant, Placebo Comparator, Standard of Care, Rimegepant.
- Who it may be relevant to
- Registry conditions: Menstrual Migraine. Basic parameters: 18 years — 45 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Argentina, Canada, China, Denmark +10
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Interventions
- Drug Rimegepant
Rimegepant 75 mg ODT for 7 days - Drug Placebo Comparator
Matching placebo oral disintegrating tablets for 7 days - Drug Standard of Care
Standard of care for acute treatment as needed - Drug Rimegepant
Rimegepant 75 mg ODT for acute treatment as needed
Primary outcome measures
- Mean change from the Observation Period in number of migraine days per 5-day perimenstrual period across each cycle of the Double-Blind Treatment Phase [Time frame: 5 months (5 menstrual cycles)]
Secondary outcome measures (11)
- Mean change from the Observation Period in number of headache days per 5-day perimenstrual period across each cycle of the Double-Blind Treatment Phase [Time frame: 5 months (5 menstrual cycles)]
- Percentage of participants with ≥50% reduction from the Observation Period in number of migraine days per 5-day perimenstrual period across each cycle of the Double-Blind Treatment Phase (50% responder) [Time frame: 5 months (5 menstrual cycles)]
- Mean change from the Observation Period in number of acute migraine medication days per 5-day perimenstrual period across each cycle of the Double-Blind Treatment Phase [Time frame: 5 months (5 menstrual cycles)]
- Mean change from the Observation Period in number of acute migraine-specific medication days per 5-day perimenstrual period across each cycle of the Double-Blind Treatment Phase [Time frame: 5 months (5 menstrual cycles)]
- Mean change from the Observation Period in number of migraine days with moderate-severe functional disability per 5-day perimenstrual period across each cycle of the Double-Blind Treatment Phase [Time frame: 5 months (5 menstrual cycles)]
- Mean change from the Observation Period in number of moderate-severe headache days per 5-day perimenstrual period across each cycle of the Double-Blind Treatment Phase [Time frame: 5 months (5 menstrual cycles)]
- Mean change from the Observation Period in number of moderate-severe migraine days per 5-day perimenstrual period across each cycle of the Double-Blind Treatment Phase [Time frame: 5 months (5 menstrual cycles)]
- Mean change from baseline in the MiCOAS Cognition score at postdosing (ie, 1 day after the 7-day dosing period) across each cycle of the Double-Blind Treatment Phase [Time frame: 5 months (5 menstrual cycles)]
- Mean change from the Observation Period in monthly migraine days (per cycle, normalized to 28-days) across each cycle of the Double-Blind Treatment Phase [Time frame: 5 months (5 menstrual cycles)]
- Mean change from the Observation Period in monthly headache days (per cycle, normalized to 28-days) across each cycle of the Double-Blind Treatment Phase [Time frame: 5 months (5 menstrual cycles)]
- Mean change from the Observation Phase in monthly acute migraine-specific medication days (per cycle, normalized to 28-days) across each cycle of the Double-Blind Treatment Phase [Time frame: 5 months (5 menstrual cycles)]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Single group
- Masking
- Quadruple blind
- Primary purpose
- Prevention
Study locations
United States · 32 centers
- Mayo Clinic Hospital — Phoenix
- Mayo Clinic Specialty Building — Phoenix
- Mayo Clinic Arizona — Scottsdale
- Hope Clinical Research, Inc. — Canoga Park
- Axiom Research — Colton
- Diablo Clinical Research, Inc. — Walnut Creek
- VIN - Aventura — Aventura
- Velocity Clinical Research, Hallandale Beach — Hallandale
- … and 24 more centers
China · 10 centers
- Peking University People's Hospital — Beijing
- The First Affiliated Hospital of Chongqing Medical University — Chongqing
- Hebei General Hospital — Shijiazhuang
- The Second Affiliated Hospital of Nanjing Medical University — Nanjing
- The First Affiliated Hospital of Soochow University — Suzhou
- Shaanxi provincial people's hospital — Xi'an
- Xianyang Hospital of Yan'an University — Xianyang
- Huashan Hospital, Fudan University — Shanghai
- … and 2 more centers
Spain · 9 centers
Center list to be confirmed — check the primary protocol.
India · 8 centers
- Lalitha PVS Institute of Medical Sciences — Guntur
- Marengo CIMS Hospital, Ahmedabad — Ahmedabad
- Mallikatta Neuro Centre — Mangaluru
- Topiwala National Medical College & B. Y. L. Nair Charitable Hospital — Mumbai
- Getwell Hospital and Research Institute — Nagpur
- Chopda Medicare & Research Centre Pvt. Ltd: Magnum Heart Institute — Nashik
- Jawahar Lal Nehru Medical College — Ajmer
- Sanjay Gandhi Post Graduate Institute of Medical Sciences — Lucknow
Poland · 8 centers
Center list to be confirmed — check the primary protocol.
United Kingdom · 8 centers
Center list to be confirmed — check the primary protocol.
Canada · 7 centers
- CaRe Clinic — Red Deer
- OCT Research ULC — Kelowna
- Centre for Neurology Studies — Surrey
- Centricity Research Halifax Multispecialty — Halifax
- Aggarwal and Associates Limited — Brampton
- Bluewater Clinical Research Group Inc. — Sarnia
- Centre de Recherche Saint-Louis inc. — Lévis
Italy · 7 centers
- Ospedale Civile SS. Nicola e Filippo Avezzano Pronto Soccorso — Avezzano
- Fondazione Policlinico Universitario Campus Biomedico — Rome
- Ospedale Bellaria- Azienda USL di Bologna — Bologna
- Azienda Ospedaliera Universitaria Careggi — Florence
- Ospedale San Raffaele — Milan
- Fondazione Istituto Neurologico C. Mondino — Pavia
- IRCCS San Raffaele Roma — Roma
Japan · 7 centers
- Konan Medical Center — Kobe
- Tatsuoka Neurology Clinic — Kyoto-shi Shimogyo-ku
- Sendai Headache and Neurology Clinic — Sendai
- Tokyo Headache Clinic — Shibuya-ku
- … and 3 more centers
Mexico · 7 centers
Center list to be confirmed — check the primary protocol.
Argentina · 6 centers
- Fundación para la lucha contra las enfermedades neurológicas de la infancia — CABA
- IDIM - Instituto de Investigaciones Metabólicas — Buenos Aires
- Mautalen Salud e Investigación — Buenos Aires
- Hospital Cordoba — Cordoba Capital
- Sanatorio del Sur — San Miguel de Tucumán
- Clínica Privada Gallia — Córdoba
South Korea · 5 centers
Center list to be confirmed — check the primary protocol.
Germany · 4 centers
- Klinische Forschung Schwerin GmbH — Schwerin
- Charité Universitaetsmedizin Berlin - Campus Mitte — Berlin
- FutureMeds GmbH — Berlin
- Neurologie Berlin — Berlin
Netherlands · 3 centers
Center list to be confirmed — check the primary protocol.
Denmark · 2 centers
- Rigshospitalet, Glostrup — Glostrup Municipality
- Region Midtjylland, Regionshospitalet Viborg — Viborg
Identifiers
NCT: NCT06641466 · C4951063 · NCT06641466