MigrainePhase 3NCT05156398
Efficacy and Safety Study of Rimegepant for the Preventative Treatment of Migraine in Pediatric Subjects
A Phase 3 study testing Rimegepant in people with Migraine, run by Pfizer at 93 sites in 7 countries.
Trial summary
The purpose of this study is to compare the efficacy and safety of rimegepant to placebo as a preventative treatment for migraine in children and adolescents ≥ 6 to <18 years with episodic migraine. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Migraine
- What is being tested?
- Rimegepant
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 640 participants
- Where
- 93 sitesin 7 countries
- Study dates
- 28 Feb 2022to 30 Oct 2032
- 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 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Subject has at least a 6 month history of migraine (with or without aura) and including the following:
- 14 or less headache days per month during the 3 month period prior to the Screening Visit
- 6 or more migraine days during the Observation Period
- 14 or less headache days during the Observation Period
- Pediatric Migraine Disability Assessment Scale (PedMIDAS) Disability Score of >10 to ≤50, indicating mild (score of 11 to 30) or moderate (score of 31 to 50) disruption in daily activities, as assessed at the Baseline (Randomization) Visit
- Ability to verbally distinguish migraine attacks from tension/cluster or other types of headaches
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- Migraine attacks, on average, lasting 4 - 72 hours if untreated
- Subjects on prophylactic migraine medication are permitted to remain on therapy if the dose has been stable for at least 3 months (12 weeks) prior to the Screening Phase, and the dose is not expected to change during the course of the study. 2) Male and female subjects ≥ 6 to <18 years; subjects must be less than 18 at the time of signing assent / consent.
- 3)Subjects must have a weight of ≥40 kg (child cohort requirement ≥15 kg) at the Screening Visit.
Who cannot join
- Subjects with a history of basilar migraine, cluster headaches, or hemiplegic migraine
- The subject has a continuous migraine (defined as an unrelenting headache) within 1 month prior to Screening Visit.
- The subject has a history or diagnosis of complications of migraine
- The subject has a confounding and clinically significant pain syndrome that may interfere with the subject's ability to participate in this study.
- The subject has any current psychiatric condition that is uncontrolled and/or untreated for a minimum of 6 months prior to the Screening Visit. Subjects with a lifetime history of psychosis and/or mania are excluded.
- History of suicidal behavior or the subject is at risk of self-harm or harm to others.
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- History of major psychiatric disorder.
- The subject has a current diagnosis or history of substance abuse
- The subject has a history of moderate or severe head trauma or other neurological disorder (including seizure disorder) or systemic medical disease that is, in the investigator's opinion, likely to affect central nervous system functioning.
Trial locations and contacts
93 sites in 7 countries. Contact the study team or a site near you to ask about taking part.
93 sites in 7 countries
United States56 sites, 31 recruiting
- Active, not recruiting
Dent Neurosciences Research Center, Inc.
Amherst, New York, 14226
- Recruiting
Clinical Trial Office
Augusta, Georgia, 30904
- Recruiting
Augusta University
Augusta, Georgia, 30912
- Recruiting
Northwest Clinical Trials, Inc.
Boise, Idaho, 83704
- Active, not recruiting
Coastal Pediatric Research
Charleston, South Carolina, 29414
- Terminated
Diamond Headache Clinic
Chicago, Illinois, 60642
- Recruiting
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
- Active, not recruiting
Velocity Clinical Research
Cincinnati, Ohio, 45242
- Terminated
Safe Haven Clinical Research
Clinton, Mississippi, 39056
- Active, not recruiting
Colorado Springs Neurological Associates
Colorado Springs, Colorado, 80907
- Recruiting
Roy Blunt NextGen Precision Health Building
Columbia, Missouri, 65211
- Recruiting
University of Missouri Health Care - Investigation Pharmacy
Columbia, Missouri, 65212
- Recruiting
University of Missouri-Clinical and Translational Sciences Unit
Columbia, Missouri, 65212
- Recruiting
University of Missouri
Columbia, Missouri, 65212
- Recruiting
Alina Clinical Trials, LLC.
Dallas, Texas, 75209
- Not yet recruiting
NRST - Detroit
Detroit, Michigan, 48203
- Active, not recruiting
Accel Research Sites Network - Edgewater Clinical Research Unit
Edgewater, Florida, 32132
- Active, not recruiting
Carolina Institute for Clinical Research, LLC
Fayetteville, North Carolina, 28303
- Terminated
Advanced Neurosciences Research, LLC
Fort Collins, Colorado, 80528
- Active, not recruiting
The Belinga Clinic
Fort Smith, Arkansas, 72901
- Recruiting
North Texas Center for Clinical Research
Frisco, Texas, 75034
- Recruiting
Velocity Clinical Research, Grand Island
Grand Island, Nebraska, 68803
- Terminated
Tribe Clinical Research LLC
Greenville, South Carolina, 29607
- Recruiting
Advanced Investigative Medicine, Inc.
Hawthorne, California, 90250
- Recruiting
Direct Helpers Research Center
Hialeah, Florida, 33012
- Terminated
New Med Research, Inc
Hollywood, Florida, 33020
- Recruiting
DM Clinical Research - Cy Fair
Houston, Texas, 77065
- Recruiting
SCLA Management - Drop Box
Houston, Texas, 77077
- Recruiting
SCLA Management Office
Houston, Texas, 77077
- Recruiting
NeuroCare Plus
Houston, Texas, 77094
- Active, not recruiting
Velocity Clinical Research San Diego
La Mesa, California, 91942
- Active, not recruiting
Red Star Research, LLC
Lake Jackson, Texas, 77566
- Recruiting
DCT-McAllen Primary Care Research, LLC dba Discovery Clinical Trials
McAllen, Texas, 78503
- Not yet recruiting
Clinical Research Institute
Minneapolis, Minnesota, 55402
- Terminated
Monroe Carell Jr Children's Hospital at Vanderbilt
Nashville, Tennessee, 37232
- Recruiting
Nola Research Works, LLC
New Orleans, Louisiana, 70125
- Active, not recruiting
Lynn Health Science Institute
Oklahoma City, Oklahoma, 73112
- Active, not recruiting
Complete Health Research
Ormond Beach, Florida, 32174
- Recruiting
Papillion Research Center/CCT Research
Papillion, Nebraska, 68046
- Active, not recruiting
Meridian Clinical Research, LLC
Portsmouth, Virginia, 23703
- Active, not recruiting
Renown Regional Medical Center
Reno, Nevada, 89502
- Recruiting
DCT-Stone Oak, LLC dba Discovery Clinical Trials
San Antonio, Texas, 78258
- Active, not recruiting
WR-Mount Vernon Clinical Research, LLC
Sandy Springs, Georgia, 30328
- Active, not recruiting
Meridian Clinical Research, LLC
Savannah, Georgia, 31406
- Active, not recruiting
Texas Institute for Neurological Disorders
Sherman, Texas, 75092
- Recruiting
Avera McKennan Hospital & University Health Center
Sioux Falls, South Dakota, 57105
- Recruiting
Avera Research Institute
Sioux Falls, South Dakota, 57108
- Recruiting
Avera Medical Group Pediatrics - Dawley Farm
Sioux Falls, South Dakota, 57110
- Active, not recruiting
Extraordinary Family Healthcare
Snellville, Georgia, 30078
- Active, not recruiting
Renew Health Clinical Research LLC
Snellville, Georgia, 30078
- Recruiting
D&H Tamarac Research Center LLC
Tamarac, Florida, 33321
- Recruiting
Santos Research Center, CORP
Tampa, Florida, 33615
- Recruiting
Montefiore Medical Center
The Bronx, New York, 10461
- Recruiting
DM Clinical Research (Administrative Office Only)
Tomball, Texas, 77375
- Terminated
Victoria Clinical Research Group
Victoria, Texas, 77901
- Recruiting
Velocity Clinical Research, Washington DC
Washington D.C., District of Columbia, 20016
Japan13 sites, 13 recruiting
- Recruiting
Tennouji Dai Brain Clinic
Abeno-ku Osaka-shi, Osaka, 545-0053
- Recruiting
Saitama Neuropsychiatric Institute
Chuo-ku Saitama-shi, Saitama, 338-8577
- Recruiting
Konan Medical Center
Higashinada-ku Kobe-shi, Hyōgo, 658-0064
- Recruiting
Tanaka Neurosurgery & Headache Clinic
Kagoshima, Kagoshima-ken, 890-0052
- Recruiting
Jinnouchi Neurosurgical Clinic
Kasuga-shi, Fukuoka, 816-0802
- Recruiting
Hikita Pediatric Clinic
Kiryu-shi, Gunma, 376-0035
- Recruiting
Atago Hospital
Kochi, Kochi, 780-0051
- Not yet recruiting
Mito Kyodo General Hospital
Mito, Ibaraki, 310-0015
- Recruiting
Tominaga Clinic
Naniwa-ku, Osaka, 556-0015
- Recruiting
Yamaguchi Clinic
Nishinomiya-shi, Hyōgo, 663-8204
- Recruiting
Tokyo Headache Clinic
Shibuya-ku, Tokyo, 151-0051
- Recruiting
Tokyo Medical University Hospital
Shinjuku-ku, Tokyo, 160-0023
- Recruiting
Sendai Headache and Neurology Clinic
Taihaku-ku Sendai-shi, Miyagi, 982-0014
Poland8 sites, 6 recruiting
- Active, not recruiting
NZOZ Wielospecjalistyczna Poradnia Lekarska SYNAPSIS
Katowice, Silesian Voivodeship, 40-123
- Recruiting
Neurologia Slaska Centrum Medyczne
Katowice, Silesian Voivodeship, 40-689
- Recruiting
Wojewodzki Specjalistyczny Szpital Dzieciecy
Krakow, Lesser Poland Voivodeship, 31-503
- Recruiting
NZOZ Neuromed M. i M. Nastaj Sp. P.
Lublin, Lublin Voivodeship, 20-064
- Recruiting
Clinical Research Center Sp. z o.o. MEDIC-R Sp. k.
Poznan, Greater Poland Voivodeship, 61-731
- Active, not recruiting
MTZ Clinical Research Powered by Pratia
Warsaw, Masovian Voivodeship, 02-172
- Recruiting
Next Stage Sp. Z o.o.
Warsaw, WOJ. Mazowieckie, 02-121
- Recruiting
MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak
Wroclaw, Lower Silesian Voivodeship, 52-210
Italy6 sites, 6 recruiting
- Recruiting
UOSVD Centro Epilessia ed EEG dellEta Evolutiva
Bari, BARI / Puglia, 70132
- Recruiting
ASST Spedali Civili di Brescia
Brescia, 25069
- Recruiting
Sapienza Universita di Roma Polo Pontino - ICOT, Headache clinic
Latina, Latina/lazio, 04100
- Recruiting
Istituto Neurologico "Carlo Besta" Fondazione IRCCS
Milan, Lombardy, 20133
- Recruiting
IRCCS San Raffaele
Rome, Lazio, 00166
- Recruiting
Divisione di Neurologia, Ospedale Pediatrico Bambino Gesu
Rome, Rome/lazio, 00165
Spain6 sites, 6 recruiting
- Recruiting
Instituto de Investigaciones del Sueno
Madrid, 28036
- Recruiting
Hospital Universitari Parc Tauli
Sabadell, Barcelona, 08208
- Recruiting
Virgen del Rocio Hospital
Seville, 41013
- Recruiting
Hospital Universitario y Politecnico La Fe
Valencia, 46026
- Recruiting
Hospital Clinico Universitario de Valladolid (HCUV)
Valladolid, Castille and León, 47003
- Recruiting
Hospital Alvaro Cunqueiro
Vigo, Galicia, 36312
France3 sites, 2 recruiting
- Recruiting
Centre Hospitalier Intercommunal de Creteil
Créteil, 94000
- Active, not recruiting
Centre Hospitalier Universitaire de Montpellier
Montpellier, 34295
- Recruiting
Hopital des Enfants
Toulouse, 31059
Canada1 site
- Terminated
Children's and Women's Health Centre of British Columbia
Vancouver, British Columbia, V6H 3V4
About this study
Official title: A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Rimegepant in Migraine Prevention in Children and Adolescents ≥ 6 to <18 Years of Age
The purpose of this study is to compare the efficacy and safety of rimegepant to placebo as a preventative treatment for migraine in children and adolescents ≥ 6 to <18 years with episodic migraine.
- Conditions
- Migraine
- Being tested
- Rimegepant, Placebo
- Keywords
- Migraine, Migraine prevention, Phonophobia, Photophobia, Nausea, Pediatric migraine, Adolescent migraine
- Medical subject headings
- Migraine Disorders, Hyperacusis, Photophobia, Nausea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RimegepantDrug
Also called BHV3000
Rimegepant 75mg or 50mg (2 X 25mg) ODT
PlaceboDrug
Also called Matching Placebo
Matching placebo 75mg or 50mg (2 X 25mg) ODT
| Study group | Role | What they receive |
|---|---|---|
| Rimegepant / BHV3000 | Active comparator | Rimegepant 75mg or 50mg (2 X 25mg) ODT Receives: Drug: Rimegepant |
| Matching Placebo | Placebo comparator | Matching placebo 75mg or 50mg (2 X 25mg) ODT Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the mean number of migraine days per month as measured over the 12-week double-blind phase of the study in adolescents with episodic migraine
Reduction from baseline in mean number of migraine days per month
Measured: 3 months (12 weeks)
Secondary outcomes (8)
Achievement of at least a 50% reduction from baseline in mean monthly migraine days over the course of the double-blind phase in adolescents with episodic migraine
Measured: 3 months (12 weeks)
Change from baseline in the mean number of migraine days per month in the first 4 weeks (Weeks 1 through 4) of the double-blind treatment phase in adolescents with episodic migraine.
Measured: Weeks 1 through 4 of treatment
The mean change from baseline in the Pediatric Quality of Life (PedsQL™) total score at Week 12 of the double-blind treatment phase in adolescents with episodic migraine.
Measured: Total score at week 12
Change from baseline in the mean number of migraine days per month over the entire course of the double-blind treatment phase in children and children and adolescents combined with episodic migraine.
Measured: 3 months (12 weeks)
Change from baseline on the proportion of subjects that have at least a 50% reduction in the mean number of moderate to severe migraine days per month.
Measured over the entire course of the double-blind treatment phase in children and children and adolescents combined with episodic migraine.
Measured: 3 months (12 weeks)
Compare the use of acute migraine-specific medications (triptans) based on the change from baseline in monthly acute migraine specific medication days.
Measured in each month and over the course of the entire double-blind treatment phase in adolescents, children and adolescents and children combined.
Measured: 3 months (12 weeks)
Evaluate the safety and tolerability of rimegepant as a preventative treatment for migraine in children and adolescents.
This will be evaluated by the number of subjects with treatment related adverse events by severity.
Measured: 72 Weeks
Evaluate the frequency of hepatic-related adverse events in subjects treated with rimegepant.
Measured by discontinuations in treated subjects due to elevated liver function tests.
Measured: 72 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2021
- Study start28 Feb 2022
- Primary completion27 Mar 2029 (estimated)
- Study completion30 Oct 2032 (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
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 640 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
- NCT05156398
- Sponsor's protocol ID
- BHV3000-315
- Other IDs
- C4951009, 2021-005246-15, 2021-005246-15, 2024-512382-13-00
- Status last verified
- Oct 2026
- First submitted
- 19 Nov 2021
- Last updated
- 14 Oct 2026
- Results posted
- No
- 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