MigrainePhase 3NCT06616194
A Study to Learn About the Study Medicine Called Rimegepant in Adolescents With Frequent Migraine
A Phase 3 study testing Rimegepant in people with Migraine, run by Pfizer at 102 sites in 12 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Migraine
- What is being tested?
- Rimegepant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 636 participants
- Where
- 102 sitesin 12 countries
- Study dates
- 15 Nov 2024to 22 Apr 2031
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Unrelenting headache
- 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
- Use of more than one medication for migraine prevention/prophylaxis
- Participation in another clinical trial at the same time
Trial locations and contacts
102 sites in 12 countries.
102 sites in 12 countries
United States27 sites
Michigan Headache & Neurological Institute
Ann Arbor, Michigan, 48104
Children's Hospital Colorado
Aurora, Colorado, 80045
Dell Children's Medical Center
Austin, Texas, 78723
OnSite Clinical Solutions
Charlotte, North Carolina, 28211
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
Chicago Headache Center and Research Institute
Chicago, Illinois, 60657
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Cleveland Clinic
Cleveland, Ohio, 44195
Duke Health Center Creekstone
Durham, North Carolina, 27703
Duke Lenox Baker Children's
Durham, North Carolina, 27705
Duke Children's Health Center
Durham, North Carolina, 27710
Headlands-EI Paso
El Paso, Texas, 79902
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Adult & Child Neurology Medical Associates
Long Beach, California, 90806
Chicago Headache Center and Research Institute
Naperville, Illinois, 60563
Rutgers University
New Brunswick, New Jersey, 08901
Xenoscience Inc
Phoenix, Arizona, 85004
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224
Wasatch Clinical Research, LLC
Salt Lake City, Utah, 84107
Granger Medical Holladay - Holladay Clinic
Salt Lake City, Utah, 84117
Seattle Children's Hospital
Seattle, Washington, 98105
Avera Medical Group Pediatric Specialists
Sioux Falls, South Dakota, 57105
Avera Research Institute - Sioux Falls
Sioux Falls, South Dakota, 57108
Avera Medical Group Pediatrics - Dawley Farm
Sioux Falls, South Dakota, 57110
Clinvest Headlands Llc
Springfield, Missouri, 65807
Wake Forest University Baptist Medical Center ( WFUBMC )
Winston-Salem, North Carolina, 27157
New England Regional Headache Center
Worcester, Massachusetts, 01609
China14 sites
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011
The Third Xiangya Hospital of Central South University
Changsha, Hunan, 410013
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400016
Guangzhou First People's Hospital
Guangzhou, Guangdong, 510180
Anhui Provincial Hospital
Hefei, 230001
Jingzhou First People's Hospital
Jingzhou, Hubei, 434000
Shanghai Children's Hospital
Shanghai, 200062
The Second Affiliated Hospital of Hebei Medical University
Shijiazhuang
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006
Wuhan Children's Hospital
Wuhan, Hubei, 430010
Wuxi Children's Hospital
Wuxi, Jiangsu, 214023
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, 750004
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu, 212001
Poland9 sites
AthleticoMed
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-752
Specjalistyczne Gabinety Sp. z o.o.
Krakow, Lesser Poland Voivodeship, 30-539
Centrum Medyczne Hope Clinic Sebastian Szklener
Lublin, Lublin Voivodeship, 20-701
NZOZ Neuromed M. i M. Nastaj Sp. P.
Lublin, 20-064
Dr Sękowska Leczenie Bólu
Warsaw, Masovian Voivodeship, 01-018
Neurosphera
Warsaw, Masovian Voivodeship, 02-829
Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor Kierkuś
Warsaw, Masovian Voivodeship, 04-501
MIGRE Polskie Centrum Leczenia Migreny
Wroclaw, Lower Silesian Voivodeship, 52-210
MedicArt Sp. z o. o.
Wroclaw, Lower Silesian Voivodeship, 53-025
Finland8 sites
Clinical Research Institute Helsinki University Central Hospital Ltd
Helsinki, 00280
New Children's Hospital
Helsinki, 00290
Kuopion Yliopistollinen Sairaala
Kuopio, Northern Savonia, 70210
Terveystalo Oulu
Oulu, North Ostrobothnia, 90100
Tampereen yliopistollinen sairaala
Tampere, Pirkanmaa, 33520
Terveystalo Tampere
Tampere, 33100
Turku University Hospital
Turku, Southwest Finland, 20520
Terveystalo Pulssi
Turku, 20100
Italy8 sites
Ospedale San Paolo Bari
Bari, Apulia, 70132
Asst Spedali Civili Di Brescia
Brescia, 25123
ASL1 Avezzano-Sulmona-L'Aquila
L’Aquila, Abruzzo, 67100
I.C.O.T. Università La Sapienza
Latina, 04100
IRCCS Istituto Neurologico Carlo Besta
Milan, Lombardy, 20133
Fondazione Istituto Neurologico C. Mondino
Pavia, 27100
IRCCS San Raffaele Roma
Roma, 00166
IRCCS San Raffaele Roma
Rome, ROMA, 00163
Japan7 sites
Tanaka Neurosurgery&Headache Clinic
Kagoshima, 890-0052
Nagaseki Headache Clinic
Kai, Yamanashi, 400-0124
Konan Medical Center
Kobe, Hyōgo, 658-0064
Yamaguchi Clinic
Nishinomiya, Hyōgo, 663-8204
Tominaga Clinic
Osaka, Osaka, 556-0015
Tennoji Department of Neurosurgery
Osaka, 545-0053
Tokyo Headache Clinic
Shibuya-ku, Tokyo, 151-0051
Spain7 sites
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona [barcelona], 08035
Hospital Universitario HM Puerta del Sur
Madrid, Madrid, Comunidad de, 28938
Hospital Universitario HM Sanchinarro
Madrid, 28050
Hospital Universitario Virgen Del Rocio
Seville, 41013
Hospital Universitari i Politecnic La Fe
Valencia, 46026
Hospital Clínico Universitario de Valladolid
Valladolid, 47005
CHUVI- Hospital Alvaro Cunqueiro
Vigo, Pontevedra, 36213
Czechia5 sites
Detska nemocnice FN Brno
Brno, Brno-město, 613 00
Fakultni nemocnice Hradec Kralove
Hradec Králové, Hradec Králové, 500 05
Fakultni nemocnice Ostrava
Ostrava, Moravian-Silesian Region, 708 52
Fakultni Thomayerova nemocnice
Prague, Praha 4, 14059
Fakultni Nemocnice Motol a Homolka
Prague, 150 06
India5 sites
Artemis hospital
Gurugram, Haryana, 122001
Mallikatta Neuro Centre
Mangalore, Karnataka, 575002
Chopda Medicare & Research Centre Pvt. Ltd; Magnum Heart Institute
Nashik, Maharashtra, 422005
All India Institute of Medical Sciences
New Delhi, National Capital Territory of Delhi, 110029
Sir Ganga Ram Hospital
New Delhi, National Capital Territory of Delhi, 110060
Canada4 sites
University Of Alberta Hospital
Edmonton, Alberta, T6G 1W9
Stollery Children's Hospital
Edmonton, Alberta, T6G 2B7
London Health Sciences Centre - Verspeeten Family Cancer Centre
London, Ontario, N6A 5W9
CaRe Clinic
Red Deer, Alberta, T4P 1K4
Hungary4 sites
Dr. Kenessey Albert Kórház
Balassagyarmat, Nógrád megye, 2660
Semmelweis Egyetem
Budapest, 1083
Semmelweis Egyetem
Budapest, 1094
Nagykanizsai Kanizsai Dorottya Korhaz
Nagykanizsa, Zala County, 8800
Slovakia4 sites
Detska fakultna nemocnica s poliklinikou Banska Bystrica
Banská Bystrica, 97409
IN MEDIC s.r.o.
Bardejov
KONZILIUM s.r.o.
Dubnica nad Váhom
Univerzitna nemocnica Martin
Martin, 036 59
About this study
Official title: 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
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.
Read more
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.
- Conditions
- Migraine
- Being tested
- Rimegepant, Placebo
- Keywords
- Chronic migraine, adolescents, rimegepant,, cgrp
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RimegepantDrug
Rimegepant 75 mg orally disintegrating tablets
PlaceboDrug
Matching placebo oral disintegrating tablets
| Study group | Role | What they receive |
|---|---|---|
| Rimegepant | Experimental | Experimental medicine under study Receives: Drug: Rimegepant |
| Placebo | Placebo comparator | A placebo does not have any medicine in it but looks just like the medicine being studied. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of migraine days per month
Efficacy of rimegepant relative to placebo, measured as mean change from the baseline in the number of migraine days per month
Measured: 12 Weeks
Secondary outcomes (8)
Efficacy of rimegepant relative to placebo measured as the mean change from baseline in the number of acute migraine-specific medication days per month
Change in the use of acute migraine-specific medication days per month
Measured: 12 Weeks
Efficacy of rimegepant relative to placebo measured the mean change from baseline in the number of moderate or severe headache days per month
Change in headache days per month
Measured: 12 Weeks
Efficacy of rimegepant relative to placebo measured as the percentage of participants with at least 50% reduction from baseline in number of moderate or severe migraine days per month
Change in moderate or severe migraine days per month
Measured: 12 weeks
Efficacy of rimegepant relative to placebo measured as the mean change from baseline in the Pediatric Quality of Life (PedsQL™) total score
Change in the Quality of Life
Measured: 12 Weeks
Efficacy of rimegepant relative to placebo measure as the mean change from baseline in the number of acute headache medication days per month, and acute migraine-specific medication days per month
Change in headache and migraine rescue medication(s) used
Measured: 12 Weeks
Safety of rimegepant relative to placebo, and safety of rimegepant given for a long period of time measured as the number and percentage of participants with adverse event by severity and overall
Safety and tolerability of the study drug
Measured: Up to 15 months
Safety of rimegepant relative to placebo, and safety of rimegepant given for long period of time measured as the number and percentage of participants with liver-related adverse event and action taken
Safety monitoring of adverse events of special interest
Measured: Up to 15 Months
Efficacy of rimegepant relative to placebo measured as mean change from baseline in the PedMIDAS total score
Change in the Quality of Life
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2024
- Study start15 Nov 2024
- Primary completion26 Feb 2030 (estimated)
- Study completion22 Apr 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 636 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06616194
- Sponsor's protocol ID
- C4951013
- Other IDs
- BHV3000-320, 2023-505601-16-00, 2023
- Status last verified
- Oct 2026
- First submitted
- 24 Sep 2024
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Publications
Shin L, Mentz O, Gelfand AA, de Prado BM, Shapiro H, Oh A, Onifade OO, Saunders J, Raj N, Szperka CL. Gepants for headache prevention in children and adolescents: A multicenter chart review study. Headache. 2026 Jan;66(1):239-248. doi: 10.1111/head.15087. Epub 2025 Nov 14.
PubMed 41235617