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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

Full criteria on ClinicalTrials.gov

Sites (104)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Stollery Children'S Hospital
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EdmontonCanadaUnknown status
University of Alberta Hospital
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EdmontonCanadaUnknown status
London Health Sciences Centre - Verspeeten Family Cancer Centre
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LondonCanadaUnknown status
CaRe Clinic
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Red DeerCanadaUnknown status
Peking University People's Hospital
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BeijingChinaUnknown status
The Third Xiangya Hospital of Central South University
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ChangshaChinaUnknown status
The Second Xiangya Hospital of Central South University
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ChangshaChinaUnknown status
The First Affiliated Hospital of Chongqing Medical University
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ChongqingChinaUnknown status
Guangzhou First People's Hospital
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GuangzhouChinaUnknown status
Anhui Provincial Hospital
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HefeiChinaUnknown status
Jingzhou First People's Hospital
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JingzhouChinaUnknown status
Shanghai Children's Hospital
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ShanghaiChinaUnknown status
The Second Affiliated Hospital of Hebei Medical University
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ShijiazhuangChinaUnknown status
The First Affiliated Hospital of Soochow University
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SuzhouChinaUnknown status
Wuhan Children's Hospital
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WuhanChinaUnknown status
Wuxi Children's Hospital
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WuxiChinaUnknown status
General Hospital of Ningxia Medical University
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YinchuanChinaUnknown status
Affiliated Hospital of Jiangsu University
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ZhenjiangChinaUnknown status
Fakultni Nemocnice Brno
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Brno-SeverCzechiaActive, not recruiting
Fakultni Nemocnice Hradec Kralove
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Novy Hradec KraloveCzechiaActive, not recruiting
Fakultni nemocnice Ostrava
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OstravaCzechiaActive, not recruiting
Fakultni nemocnice v Motole
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PragueCzechiaActive, not recruiting
Fakultni Thomayerova nemocnice
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Prague 4CzechiaActive, not recruiting
Hospital Universitari Vall d'Hebron
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BarcelonaSpainActive, not recruiting
Hospital Universitario HM Puerta del Sur
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MóstolesSpainActive, not recruiting
Clínica Universidad de navarra
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PamplonaSpainActive, not recruiting
University Hospital Virgen Del Rocio S.L.
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SevillaSpainActive, not recruiting
Hospital Universitario Y Politecnico La Fe
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ValenciaSpainActive, not recruiting
Hospital Clínico Universitario de Valladolid
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ValladolidSpainActive, not recruiting
Hospital Alvaro Cunqueiro
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VigoSpainActive, not recruiting
HUS-Yhtymae
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HelsinkiFinlandActive, not recruiting
Kuopio University Hospital
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KuopioFinlandActive, not recruiting
Suomen Terveystalo Oy
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OuluFinlandActive, not recruiting
Suomen Terveystalo Oy
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TampereFinlandActive, not recruiting
Tampere University Hospital
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TampereFinlandActive, not recruiting
Suomen Terveystalo Oy
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TurkuFinlandActive, not recruiting
Turku University Hospital
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TurkuFinlandActive, not recruiting
Balassagyarmati Dr. Kenessey Albert Korhaz Rendelointezet
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BalassagyarmatHungaryActive, not recruiting
Semmelweis University
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BudapestHungaryActive, not recruiting
Obudai Egeszseguegyi Centrum Kft.
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Budapest IIIHungaryActive, not recruiting
University of Debrecen
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DebrecenHungaryActive, not recruiting
Kanizsai Dorottya Korhaz
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NagykanizsaHungaryActive, not recruiting
Artemis Hospital
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GurugramIndiaUnknown status
Mallikatta Neuro Centre
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MangaloreIndiaUnknown status
Chopda Medicare & Research Centre Pvt. Ltd - Magnum Heart Institute
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NashikIndiaUnknown status
All India Institute of Medical Sciences
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New DelhiIndiaUnknown status
Sir Ganga Ram Hospital
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New DelhiIndiaUnknown status
Azienda Sanitaria Locale Della Provincia Di Bari
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BariItalyActive, not recruiting
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
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BresciaItalyActive, not recruiting
Azienda Sanitaria Locale Avezzano Sulmona L'Aquila
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L'aquilaItalyActive, not recruiting
Casa Di Cura Accreditata Istituto Chirurgico Ortopedico Traumatologico Marco Pasquali
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LatinaItalyActive, not recruiting
IRCCS Foundation Istituto Neurologico Carlo Besta
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MilanItalyActive, not recruiting
Fondazione Istituto Neurologico Nazionale Casimiro Mondino
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PaviaItalyActive, not recruiting
Irccs San Raffaele Roma S.r.l.
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RomeItalyActive, not recruiting
Azienda Ospedaliero-Universitaria Policlinico Umberto I
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RomeItalyActive, not recruiting
Tanaka Neurosurgery & Headache Clinic
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KagoshimaJapanUnknown status
Nagaseki Headache Clinic
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KaiJapanUnknown status
Konan Medical Center
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KobeJapanUnknown status
Yamaguchi Clinic
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NishinomiyaJapanUnknown status
Tominaga Clinic
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OsakaJapanUnknown status
Tennoji Department of Neurosurgery
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OsakaJapanUnknown status
Tokyo Headache Clinic
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Shibuya-kuJapanUnknown status
Athleticomed Sp. z o.o.
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BydgoszczPolandActive, not recruiting
Specjalistyczne Gabinety Sp. z o.o.
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CracowPolandActive, not recruiting
Centrum Medyczne Hope Clinic Sebastian Szklener
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LublinPolandActive, not recruiting
Niepubliczny Zaklad Opieki Zdrowotnej Neuromed M. I M. Nastaj. sp.p.
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LublinPolandActive, not recruiting
OHA-Med Sp. z o.o.
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WarsawPolandActive, not recruiting
Neurosphera SP. Z O.O
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WarsawPolandActive, not recruiting
WIP Warsaw IBD Point Profesor Kierkuś
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WarszawaPolandActive, not recruiting
MedicArt Sp. z o. o.
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WroclawPolandActive, not recruiting
Centrum Leczenia MIGRE
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WrocławPolandActive, not recruiting
Detska fakultna nemocnica s poliklinikou Banska Bystrica
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Banská BystricaSlovakiaActive, not recruiting
IN MEDIC, s.r.o.
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BardejovSlovakiaActive, not recruiting
Narodny ustav detskych chorob
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BratislavaSlovakiaActive, not recruiting
KONZILIUM s.r.o
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Dubnica nad VáhomSlovakiaActive, not recruiting
Detsky neurolog s.r.o.
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LamacSlovakiaActive, not recruiting
Univerzitna nemocnica Martin
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MartinSlovakiaActive, not recruiting
Michigan Headache & Neurological Institute
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Ann ArborUnited StatesUnknown status
Children's Hospital Colorado
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AuroraUnited StatesUnknown status
Dell Children's Medical Center
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AustinUnited StatesUnknown status
OnSite Clinical Solutions
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CharlotteUnited StatesUnknown status
Ann & Robert H. Lurie Children's Hospital of Chicago
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ChicagoUnited StatesUnknown status
Chicago Headache Center and Research Institute
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ChicagoUnited StatesUnknown status
Cincinnati Children's Hospital Medical Center
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CincinnatiUnited StatesUnknown status
Cleveland Clinic
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ClevelandUnited StatesUnknown status
Duke Health Center Creekstone
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DurhamUnited StatesUnknown status
Duke Lenox Baker Children's
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DurhamUnited StatesUnknown status
Duke Children's Health Center
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DurhamUnited StatesUnknown status
Headlands-EI Paso
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El PasoUnited StatesUnknown status
The University of Texas Health Science Center at Houston
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HoustonUnited StatesUnknown status
Adult & Child Neurology Medical Associates
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Long BeachUnited StatesUnknown status
Chicago Headache Center and Research Institute
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NapervilleUnited StatesUnknown status
Rutgers University
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New BrunswickUnited StatesUnknown status
Xenoscience Inc.
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PhoenixUnited StatesUnknown status
UPMC Children's Hospital of Pittsburgh
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PittsburghUnited StatesUnknown status
Granger Medical Holladay - Holladay Clinic
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Salt Lake CityUnited StatesUnknown status
Wasatch Clinical Research, LLC
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Salt Lake CityUnited StatesUnknown status
Seattle Children's Hospital
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SeattleUnited StatesUnknown status
Avera Medical Group Pediatrics - Dawley Farm
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Sioux FallsUnited StatesUnknown status
Avera Research Institute - Sioux Falls
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Sioux FallsUnited StatesUnknown status
Avera Medical Group Pediatric Specialists
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Sioux FallsUnited StatesUnknown status
Clinvest Headlands LLC
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SpringfieldUnited StatesUnknown status
Wake Forest University Baptist Medical Center ( WFUBMC )
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Winston-SalemUnited StatesUnknown status
New England Regional Headache Center
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WorcesterUnited StatesUnknown status

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