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

Официальное название

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

Обзор

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.

Вмешательства

• Препарат Rimegepant
  Rimegepant 75mg or 50mg (2 X 25mg) ODT
• Препарат Placebo
  Matching placebo 75mg or 50mg (2 X 25mg) ODT

Первичные конечные точки

• 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 [Срок оценки: 3 months (12 weeks)]

Вторичные конечные точки (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 [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 3 months (12 weeks)]
• Evaluate the safety and tolerability of rimegepant as a preventative treatment for migraine in children and adolescents. [Срок оценки: 72 Weeks]
• Evaluate the frequency of hepatic-related adverse events in subjects treated with rimegepant. [Срок оценки: 72 Weeks]

Критерии участия

Критерии включения

• 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
• 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.

Критерии исключения

• 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.
• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Последовательный дизайн

Маскирование

Четверное слепое

Основная цель

Профилактика

Центры проведения

США · 53 центра

• The Belinga Clinic — Fort Smith
• Advanced Investigative Medicine, Inc. — Hawthorne
• Velocity Clinical Research San Diego — La Mesa
• Colorado Springs Neurological Associates — Colorado Springs
• Advanced Neurosciences Research, LLC — Fort Collins
• Velocity Clinical Research, Washington DC — Washington D.C.
• Accel Research Sites Network - Edgewater Clinical Research Unit — Edgewater
• Direct Helpers Research Center — Hialeah
• … и ещё 45 центров

Япония · 13 центров

• Jinnouchi Neurosurgical Clinic — Kasuga-shi
• Hikita Pediatric Clinic — Kiryu-shi
• Konan Medical Center — Higashinada-ku Kobe-shi
• Yamaguchi Clinic — Nishinomiya-shi
• Mito Kyodo General Hospital — Mito
• Tanaka Neurosurgery & Headache Clinic — Kagoshima
• Atago Hospital — Kochi
• Sendai Headache and Neurology Clinic — Taihaku-ku Sendai-shi
• … и ещё 5 центров

Польша · 8 центров

• Clinical Research Center Sp. z o.o. MEDIC-R Sp. k. — Poznan
• Wojewodzki Specjalistyczny Szpital Dzieciecy — Krakow
• MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak — Wroclaw
• NZOZ Neuromed M. i M. Nastaj Sp. P. — Lublin
• … и ещё 4 центра

Италия · 6 центров

• UOSVD Centro Epilessia ed EEG dellEta Evolutiva — Bari
• Sapienza Universita di Roma Polo Pontino - ICOT, Headache clinic — Latina
• IRCCS San Raffaele — Rome
• Istituto Neurologico "Carlo Besta" Fondazione IRCCS — Milan
• Divisione di Neurologia, Ospedale Pediatrico Bambino Gesu — Rome
• ASST Spedali Civili di Brescia — Brescia

Испания · 6 центров

Список центров уточняется — проверьте первичный протокол.

Франция · 3 центра

• Centre Hospitalier Intercommunal de Creteil — Créteil
• Centre Hospitalier Universitaire de Montpellier — Montpellier
• Hopital des Enfants — Toulouse

Канада · 1 центр

• Children's and Women's Health Centre of British Columbia — Vancouver

Публикации

• 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. PMID 41235617

Идентификаторы

NCT: NCT05156398 · BHV3000-315 · C4951009 · 2021-005246-15 · 2021-005246-15 · 2024-512382-13-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗