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Efficacy and Safety Study of Rimegepant for the Preventative Treatment of Migraine in Pediatric Subjects

NCT ID: NCT05156398
Registry status: Recruiting
Study type: Interventional
Phase: Phase 3
Sponsor: Pfizer
Conditions: Migraine

Overview

ClinicalTrials.gov lists this study as Recruiting.

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

Enrollment: 640 participants (Estimated).

What is being studied

Drug: Placebo
Drug: Rimegepant
Intervention: rimegepant sulfate

Who may be eligible

Ages: 6 Years to 17 Years
Sex: All
Healthy volunteers accepted: No

ClinicalTrials.gov lists the following eligibility criteria.

Inclusion Criteria: 1. Subject has at least a 6 month history of migraine (with or without aura) and including the following: 1. 14 or less headache days per month during the 3 month period prior to the Screening Visit 2. 6 or more migraine days during the Observation Period 3. 14 or less headache days during the Observation Period 4. 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 5. Ability to verbally distinguish migraine attacks from tension/cluster or other types of headaches 6. Migraine attacks, on average, lasting 4 - 72 hours if untreated 7. 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. Exclusion Criteria: 1. Subjects with a history of basilar migraine, cluster headaches, or hemiplegic migraine 2. The subject has a continuous migraine (defined as an unrelenting headache) within 1 month prior to Screening Visit. 3. The subject has a history or diagnosis of complications of migraine 4. The subject has a confounding and clinically significant pain syndrome that may interfere with the subject's ability to participate in this study. 5. 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. 6. History of suicidal behavior or the subject is at risk of self-harm or harm to others. 7. History of major psychiatric disorder. 8. The subject has a current diagnosis or history of substance abuse 9. 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.

Study locations

93 study locations are listed.

Recruiting site status is explicitly provided for 93 locations; 61 are listed as Recruiting.

Countries: Canada, France, Italy, Japan, Poland, Spain, United States

British Columbia, Canada: 1
BARI / Puglia, Italy: 1
BRESCIA, Italy: 1
Latina/lazio, Italy: 1
Lazio, Italy: 1
Lombardy, Italy: 1
Rome/lazio, Italy: 1
Fukuoka, Japan: 1
Gunma, Japan: 1
Hyōgo, Japan: 2
Ibaraki, Japan: 1
Kagoshima-ken, Japan: 1
Kochi, Japan: 1
Miyagi, Japan: 1
Osaka, Japan: 2
Saitama, Japan: 1
Tokyo, Japan: 2
Greater Poland Voivodeship, Poland: 1
Lesser Poland Voivodeship, Poland: 1
Lower Silesian Voivodeship, Poland: 1
Lublin Voivodeship, Poland: 1
Masovian Voivodeship, Poland: 1
Silesian Voivodeship, Poland: 2
WOJ. Mazowieckie, Poland: 1
BARCELONA, Spain: 1
Castille and León, Spain: 1
Galicia, Spain: 1
Valencia, Spain: 1
Arkansas, United States: 1
California, United States: 2

Sample of listed locations

Centre Hospitalier Intercommunal de Creteil — Créteil, 94000, France — Recruiting
Hopital des Enfants — Toulouse, 31059, France — Recruiting
UOSVD Centro Epilessia ed EEG dellEta Evolutiva — Bari, BARI / Puglia, 70132, Italy — Recruiting
ASST Spedali Civili di Brescia — Brescia, BRESCIA, 25069, Italy — Recruiting
Sapienza Universita di Roma Polo Pontino - ICOT, Headache clinic — Latina, Latina/lazio, 04100, Italy — Recruiting
IRCCS San Raffaele — Rome, Lazio, 00166, Italy — Recruiting
Istituto Neurologico "Carlo Besta" Fondazione IRCCS — Milan, Lombardy, 20133, Italy — Recruiting
Divisione di Neurologia, Ospedale Pediatrico Bambino Gesu — Rome, Rome/lazio, 00165, Italy — Recruiting
Jinnouchi Neurosurgical Clinic — Kasuga-shi, Fukuoka, 816-0802, Japan — Recruiting
Hikita Pediatric Clinic — Kiryu-shi, Gunma, 376-0035, Japan — Recruiting
Konan Medical Center — Higashinada-ku Kobe-shi, Hyōgo, 658-0064, Japan — Recruiting
Yamaguchi Clinic — Nishinomiya-shi, Hyōgo, 663-8204, Japan — Recruiting
Tanaka Neurosurgery & Headache Clinic — Kagoshima, Kagoshima-ken, 890-0052, Japan — Recruiting
Atago Hospital — Kochi, Kochi, 780-0051, Japan — Recruiting
Sendai Headache and Neurology Clinic — Taihaku-ku Sendai-shi, Miyagi, 982-0014, Japan — Recruiting
Tennouji Dai Brain Clinic — Abeno-ku Osaka-shi, Osaka, 545-0053, Japan — Recruiting
Tominaga Clinic — Naniwa-ku, Osaka, 556-0015, Japan — Recruiting
Saitama Neuropsychiatric Institute — Chuo-ku Saitama-shi, Saitama, 338-8577, Japan — Recruiting
Tokyo Headache Clinic — Shibuya-ku, Tokyo, 151-0051, Japan — Recruiting
Tokyo Medical University Hospital — Shinjuku-ku, Tokyo, 160-0023, Japan — Recruiting
Clinical Research Center Sp. z o.o. MEDIC-R Sp. k. — Poznan, Greater Poland Voivodeship, 61-731, Poland — Recruiting
Wojewodzki Specjalistyczny Szpital Dzieciecy — Krakow, Lesser Poland Voivodeship, 31-503, Poland — Recruiting
MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak — Wroclaw, Lower Silesian Voivodeship, 52-210, Poland — Recruiting
NZOZ Neuromed M. i M. Nastaj Sp. P. — Lublin, Lublin Voivodeship, 20-064, Poland — Recruiting
Neurologia Slaska Centrum Medyczne — Katowice, Silesian Voivodeship, 40-689, Poland — Recruiting

Study details

Start date: February 28, 2022
Primary completion date: March 27, 2029
Completion date: October 30, 2032
First posted: December 14, 2021

Source and update information

Source: ClinicalTrials.gov
NCT ID: NCT05156398
Registry last updated: September 28, 2026
QualifiedStudies registry data refreshed: October 5, 2026
QualifiedStudies record fetched: October 5, 2026

View NCT05156398 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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