NCT06616194Active, not recruitingPhase 3
A Study to Learn About the Study Medicine Called Rimegepant in Adolescents With Frequent Migraine
AN INTERVENTIONAL, EFFICACY, AND SAFETY, PHASE 3 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY WITH AN OPEN-LABEL EXTENSION TO INVESTIGATE RIMEGEPANT IN MIGRAINE PREVENTION IN ADOLESCENTS 12 TO LESS THAN 18 YEARS OF AGE WITH CHRONIC MIGRAINE
Source: ClinicalTrials.gov · Last updated 23 Oct 2026
Brief summary (registry, in English)
The purpose of this study is to learn about the effect of a study medicine called rimegepant in adolescents who have frequent migraine attacks. Rimegepant is a tablet that disintegrates when you put it on or under your tongue. The study will enroll participants who have headache for 15 days (or more) every month, of which 8 days (or more) of migraine every month, and each untreated attack lasts for an average of 4-72 hours In the 1st part of the study approximately half of the participants will receive a rimegepant tablet every other day, and approximately half of the participants will receive an inactive oral tablet (that looks the same as the rimegepant tablet) every other day. Participant experiences when they are taking the study medicine will be compared to when they are taking the inactive tablet. This will help to determine if the study medicine is safe and effective. The 1st phase of the study will last 3 months. In the 2nd part of the study all the participants who stay on study will receive rimegepant tablet every other day. This 2nd phase of the study will last 1 year. This will help determine if the study medicine is safe when taken for a long period. Those who will participate in both phases will have up to 19 visits at the study clinic, about one every 4 weeks (this may vary from 2 to 8 weeks interval during the study). Home health visits may occur as well. A health check and blood sample will be conducted at the study clinic visits. Participants will have to complete a daily diary to record the migraine attacks.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 636 (estimated)
- First submitted
- 24 Sept 2024
- Start date
- 15 Nov 2024
- Primary completion date
- 26 Feb 2030
- Lead sponsor
- Pfizer
- Diseases
- Migraine
- NCT number
- NCT06616194
- EU CT number
- 2023-505601-16-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 636
- From 15 Nov 2024 to the primary completion date, 26 Feb 2030
- 104 sites in 12 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of more than one medication for migraine prevention/prophylaxis
Other illness
- Current psychiatric condition uncontrolled or untreated
- History of suicidal behavior or the subject is at risk of self-harm
- History of alcohol abuse and/or illicit drug use
- History of severe drug allergy
Other
- Unrelenting headache
- Participation in another clinical trial at the same time
Who the study is looking for
- At least a 6 month history of migraine (with or without aura)
- 15 or more headache days/month
- 8 or more migraine days/month
- Migraine lasting 4-72 hours if untreated
Age in the registry: 12 years to 17 years · Sex: All · Does not accept healthy volunteers
Sites (104)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Stollery Children'S Hospital Coordinator of this site? Confirm its status | Edmonton | Canada | Unknown status |
| University of Alberta Hospital Coordinator of this site? Confirm its status | Edmonton | Canada | Unknown status |
| London Health Sciences Centre - Verspeeten Family Cancer Centre Coordinator of this site? Confirm its status | London | Canada | Unknown status |
| CaRe Clinic Coordinator of this site? Confirm its status | Red Deer | Canada | Unknown status |
| Peking University People's Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| The Third Xiangya Hospital of Central South University Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
| The Second Xiangya Hospital of Central South University Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
| The First Affiliated Hospital of Chongqing Medical University Coordinator of this site? Confirm its status | Chongqing | China | Unknown status |
| Guangzhou First People's Hospital Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Anhui Provincial Hospital Coordinator of this site? Confirm its status | Hefei | China | Unknown status |
| Jingzhou First People's Hospital Coordinator of this site? Confirm its status | Jingzhou | China | Unknown status |
| Shanghai Children's Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| The Second Affiliated Hospital of Hebei Medical University Coordinator of this site? Confirm its status | Shijiazhuang | China | Unknown status |
| The First Affiliated Hospital of Soochow University Coordinator of this site? Confirm its status | Suzhou | China | Unknown status |
| Wuhan Children's Hospital Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
| Wuxi Children's Hospital Coordinator of this site? Confirm its status | Wuxi | China | Unknown status |
| General Hospital of Ningxia Medical University Coordinator of this site? Confirm its status | Yinchuan | China | Unknown status |
| Affiliated Hospital of Jiangsu University Coordinator of this site? Confirm its status | Zhenjiang | China | Unknown status |
| Fakultni Nemocnice Brno Coordinator of this site? Confirm its status | Brno-Sever | Czechia | Active, not recruiting |
| Fakultni Nemocnice Hradec Kralove Coordinator of this site? Confirm its status | Novy Hradec Kralove | Czechia | Active, not recruiting |
| Fakultni nemocnice Ostrava Coordinator of this site? Confirm its status | Ostrava | Czechia | Active, not recruiting |
| Fakultni nemocnice v Motole Coordinator of this site? Confirm its status | Prague | Czechia | Active, not recruiting |
| Fakultni Thomayerova nemocnice Coordinator of this site? Confirm its status | Prague 4 | Czechia | Active, not recruiting |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| Hospital Universitario HM Puerta del Sur Coordinator of this site? Confirm its status | Móstoles | Spain | Active, not recruiting |
| Clínica Universidad de navarra Coordinator of this site? Confirm its status | Pamplona | Spain | Active, not recruiting |
| University Hospital Virgen Del Rocio S.L. Coordinator of this site? Confirm its status | Sevilla | Spain | Active, not recruiting |
| Hospital Universitario Y Politecnico La Fe Coordinator of this site? Confirm its status | Valencia | Spain | Active, not recruiting |
| Hospital Clínico Universitario de Valladolid Coordinator of this site? Confirm its status | Valladolid | Spain | Active, not recruiting |
| Hospital Alvaro Cunqueiro Coordinator of this site? Confirm its status | Vigo | Spain | Active, not recruiting |
| HUS-Yhtymae Coordinator of this site? Confirm its status | Helsinki | Finland | Active, not recruiting |
| Kuopio University Hospital Coordinator of this site? Confirm its status | Kuopio | Finland | Active, not recruiting |
| Suomen Terveystalo Oy Coordinator of this site? Confirm its status | Oulu | Finland | Active, not recruiting |
| Suomen Terveystalo Oy Coordinator of this site? Confirm its status | Tampere | Finland | Active, not recruiting |
| Tampere University Hospital Coordinator of this site? Confirm its status | Tampere | Finland | Active, not recruiting |
| Suomen Terveystalo Oy Coordinator of this site? Confirm its status | Turku | Finland | Active, not recruiting |
| Turku University Hospital Coordinator of this site? Confirm its status | Turku | Finland | Active, not recruiting |
| Balassagyarmati Dr. Kenessey Albert Korhaz Rendelointezet Coordinator of this site? Confirm its status | Balassagyarmat | Hungary | Active, not recruiting |
| Semmelweis University Coordinator of this site? Confirm its status | Budapest | Hungary | Active, not recruiting |
| Obudai Egeszseguegyi Centrum Kft. Coordinator of this site? Confirm its status | Budapest III | Hungary | Active, not recruiting |
| University of Debrecen Coordinator of this site? Confirm its status | Debrecen | Hungary | Active, not recruiting |
| Kanizsai Dorottya Korhaz Coordinator of this site? Confirm its status | Nagykanizsa | Hungary | Active, not recruiting |
| Artemis Hospital Coordinator of this site? Confirm its status | Gurugram | India | Unknown status |
| Mallikatta Neuro Centre Coordinator of this site? Confirm its status | Mangalore | India | Unknown status |
| Chopda Medicare & Research Centre Pvt. Ltd - Magnum Heart Institute Coordinator of this site? Confirm its status | Nashik | India | Unknown status |
| All India Institute of Medical Sciences Coordinator of this site? Confirm its status | New Delhi | India | Unknown status |
| Sir Ganga Ram Hospital Coordinator of this site? Confirm its status | New Delhi | India | Unknown status |
| Azienda Sanitaria Locale Della Provincia Di Bari Coordinator of this site? Confirm its status | Bari | Italy | Active, not recruiting |
| Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia Coordinator of this site? Confirm its status | Brescia | Italy | Active, not recruiting |
| Azienda Sanitaria Locale Avezzano Sulmona L'Aquila Coordinator of this site? Confirm its status | L'aquila | Italy | Active, not recruiting |
| Casa Di Cura Accreditata Istituto Chirurgico Ortopedico Traumatologico Marco Pasquali Coordinator of this site? Confirm its status | Latina | Italy | Active, not recruiting |
| IRCCS Foundation Istituto Neurologico Carlo Besta Coordinator of this site? Confirm its status | Milan | Italy | Active, not recruiting |
| Fondazione Istituto Neurologico Nazionale Casimiro Mondino Coordinator of this site? Confirm its status | Pavia | Italy | Active, not recruiting |
| Irccs San Raffaele Roma S.r.l. Coordinator of this site? Confirm its status | Rome | Italy | Active, not recruiting |
| Azienda Ospedaliero-Universitaria Policlinico Umberto I Coordinator of this site? Confirm its status | Rome | Italy | Active, not recruiting |
| Tanaka Neurosurgery & Headache Clinic Coordinator of this site? Confirm its status | Kagoshima | Japan | Unknown status |
| Nagaseki Headache Clinic Coordinator of this site? Confirm its status | Kai | Japan | Unknown status |
| Konan Medical Center Coordinator of this site? Confirm its status | Kobe | Japan | Unknown status |
| Yamaguchi Clinic Coordinator of this site? Confirm its status | Nishinomiya | Japan | Unknown status |
| Tominaga Clinic Coordinator of this site? Confirm its status | Osaka | Japan | Unknown status |
| Tennoji Department of Neurosurgery Coordinator of this site? Confirm its status | Osaka | Japan | Unknown status |
| Tokyo Headache Clinic Coordinator of this site? Confirm its status | Shibuya-ku | Japan | Unknown status |
| Athleticomed Sp. z o.o. Coordinator of this site? Confirm its status | Bydgoszcz | Poland | Active, not recruiting |
| Specjalistyczne Gabinety Sp. z o.o. Coordinator of this site? Confirm its status | Cracow | Poland | Active, not recruiting |
| Centrum Medyczne Hope Clinic Sebastian Szklener Coordinator of this site? Confirm its status | Lublin | Poland | Active, not recruiting |
| Niepubliczny Zaklad Opieki Zdrowotnej Neuromed M. I M. Nastaj. sp.p. Coordinator of this site? Confirm its status | Lublin | Poland | Active, not recruiting |
| OHA-Med Sp. z o.o. Coordinator of this site? Confirm its status | Warsaw | Poland | Active, not recruiting |
| Neurosphera SP. Z O.O Coordinator of this site? Confirm its status | Warsaw | Poland | Active, not recruiting |
| WIP Warsaw IBD Point Profesor Kierkuś Coordinator of this site? Confirm its status | Warszawa | Poland | Active, not recruiting |
| MedicArt Sp. z o. o. Coordinator of this site? Confirm its status | Wroclaw | Poland | Active, not recruiting |
| Centrum Leczenia MIGRE Coordinator of this site? Confirm its status | Wrocław | Poland | Active, not recruiting |
| Detska fakultna nemocnica s poliklinikou Banska Bystrica Coordinator of this site? Confirm its status | Banská Bystrica | Slovakia | Active, not recruiting |
| IN MEDIC, s.r.o. Coordinator of this site? Confirm its status | Bardejov | Slovakia | Active, not recruiting |
| Narodny ustav detskych chorob Coordinator of this site? Confirm its status | Bratislava | Slovakia | Active, not recruiting |
| KONZILIUM s.r.o Coordinator of this site? Confirm its status | Dubnica nad Váhom | Slovakia | Active, not recruiting |
| Detsky neurolog s.r.o. Coordinator of this site? Confirm its status | Lamac | Slovakia | Active, not recruiting |
| Univerzitna nemocnica Martin Coordinator of this site? Confirm its status | Martin | Slovakia | Active, not recruiting |
| Michigan Headache & Neurological Institute Coordinator of this site? Confirm its status | Ann Arbor | United States | Unknown status |
| Children's Hospital Colorado Coordinator of this site? Confirm its status | Aurora | United States | Unknown status |
| Dell Children's Medical Center Coordinator of this site? Confirm its status | Austin | United States | Unknown status |
| OnSite Clinical Solutions Coordinator of this site? Confirm its status | Charlotte | United States | Unknown status |
| Ann & Robert H. Lurie Children's Hospital of Chicago Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Chicago Headache Center and Research Institute Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Cincinnati Children's Hospital Medical Center Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
| Cleveland Clinic Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| Duke Health Center Creekstone Coordinator of this site? Confirm its status | Durham | United States | Unknown status |
| Duke Lenox Baker Children's Coordinator of this site? Confirm its status | Durham | United States | Unknown status |
| Duke Children's Health Center Coordinator of this site? Confirm its status | Durham | United States | Unknown status |
| Headlands-EI Paso Coordinator of this site? Confirm its status | El Paso | United States | Unknown status |
| The University of Texas Health Science Center at Houston Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Adult & Child Neurology Medical Associates Coordinator of this site? Confirm its status | Long Beach | United States | Unknown status |
| Chicago Headache Center and Research Institute Coordinator of this site? Confirm its status | Naperville | United States | Unknown status |
| Rutgers University Coordinator of this site? Confirm its status | New Brunswick | United States | Unknown status |
| Xenoscience Inc. Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
| UPMC Children's Hospital of Pittsburgh Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
| Granger Medical Holladay - Holladay Clinic Coordinator of this site? Confirm its status | Salt Lake City | United States | Unknown status |
| Wasatch Clinical Research, LLC Coordinator of this site? Confirm its status | Salt Lake City | United States | Unknown status |
| Seattle Children's Hospital Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
| Avera Medical Group Pediatrics - Dawley Farm Coordinator of this site? Confirm its status | Sioux Falls | United States | Unknown status |
| Avera Research Institute - Sioux Falls Coordinator of this site? Confirm its status | Sioux Falls | United States | Unknown status |
| Avera Medical Group Pediatric Specialists Coordinator of this site? Confirm its status | Sioux Falls | United States | Unknown status |
| Clinvest Headlands LLC Coordinator of this site? Confirm its status | Springfield | United States | Unknown status |
| Wake Forest University Baptist Medical Center ( WFUBMC ) Coordinator of this site? Confirm its status | Winston-Salem | United States | Unknown status |
| New England Regional Headache Center Coordinator of this site? Confirm its status | Worcester | United States | Unknown status |
Related publications
- Gepants for headache prevention in children and adolescents: A multicenter chart review study.Headache · 2026 · PMID 41235617
This page is information, not medical advice. Discuss any trial with your doctor.