Идёт набор NCT04649242

Randomized Study in Children and Adolescents With Migraine: Acute Treatment

Фаза III С лечением Pediatric Migraine

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Rimegepant/BHV3000, Matching placebo.
Кому может быть актуально: Состояния в реестре: Pediatric Migraine. Базовые параметры: 6 лет — 17 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США, Канада, Китай, Япония, Мексика +4
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Phase 3, Multicenter, Randomized, Double-blind, Group Sequential, Placebo-controlled Study to Assess Efficacy and Safety of Rimegepant for the Treatment of Migraine (With or Without Aura) in Children and Adolescents ≥ 6 to < 18 Years of Age

Обзор

The purpose of this study is to test the safety and efficacy of BHV-3000 versus placebo in the acute treatment of moderate or severe migraine in children and adolescents.

Вмешательства

Препарат Rimegepant/BHV3000
BHV3000 (rimegepant) 75 mg or 50 mg ODT
Препарат Matching placebo
Matching 75 mg or 50 mg ODT placebo

Первичные конечные точки

To evaluate the efficacy of rimegepant compared with placebo in the acute treatment of migraine in adolescent population (≥ 12 to <18 years of age) as measured by pain freedom using the number of patients reporting no pain. [Срок оценки: 2 hours post-dose]

Вторичные конечные точки (12)

To compare rimegepant with placebo for pain freedom in children and adolescents combined. [Срок оценки: 2 hours post-dose]
To compare rimegepant with placebo on freedom from the most bothersome symptom (MBS) associated with migraine in adolescents. [Срок оценки: 2 hours post-dose]
To compare rimegepant with placebo on the probabilities of requiring rescue medication within in adolescents. [Срок оценки: Within 24 hours and 48 hours of initial treatment]
To compare rimegepant with placebo on sustained pain freedom in adolescents. [Срок оценки: 2 to 24 hours post-dose]
To compare rimegepant with placebo on sustained pain freedom in adolescents. [Срок оценки: 2 to 48 hours post-dose]
To compare rimegepant with placebo on the ability to function normally as reported on the Functional Disability scale in adolescents. [Срок оценки: 2 hours post-dose]
To compare rimegepant with placebo for pain freedom in children. [Срок оценки: 2 hours post-dose]
To compare rimegepant with placebo on freedom from the most bothersome symptom (MBS) associated with migraine in children and combined children and adolescents. [Срок оценки: 2 hours post-dose]
To compare rimegepant with placebo on the probabilities of requiring rescue medication in children and combined children and adolescents. [Срок оценки: Within 24 hours and 48 hours of initial treatment.]
To compare rimegepant with placebo on sustained pain freedom in children and combined children and adolescents. [Срок оценки: 2 to 24 hours post-dose]
To compare rimegepant with placebo on sustained pain freedom in children and combined children and adolescents. [Срок оценки: 2 to 48 hours post-dose]
To compare rimegepant with placebo on freedom from photophobia in adolescents, children and combined children and adolescents. [Срок оценки: 2 hours post-dose]

Критерии участия

Критерии включения

History of migraine (with or without aura) for > 6 months before Screening according to the IHS Classification ICHD-319 specifications for pediatric migraine. History may be verified using both medical records and recall by the participant and/or participant's parent(s)/legal representative(s).
History of 1 to 8 moderate or severe attacks per month during the 2 months prior to enrollment, with attacks lasting > 3 hours without treatment, and attacks occurring at intervals > 24 hours.
Prophylactic migraine medication are permitted if the dose has been stable for at least 12 weeks prior to the Baseline Visit, and the dose is not expected to change during the course of the study.

Participants may remain on one (1) medication with possible migraine prophylactic effects, excluding CGRP antagonists \[biologic or small molecule\], during the treatment phases.
Concomitant use of a CGRP antagonist, such as erenumab or fremanezumab, is prohibited.
Previously discontinued prophylactic migraine medication must have done so at least 90 days prior to the Screening Visit.
Verbally distinguish between migraine and other types of headaches.
Participants must have a weight > 40 kg at the Screening Visit.
Adequate venous access for blood sampling.
Male and female participants ≥ 6 to < 18 years of age (participants must not reach their 18th birthday during the study).

Критерии исключения

History of cluster headache or hemiplegic migraine headache.
Confounding and clinically significant pain syndrome that may interfere with the participant's ability to participate in this study.
Current psychiatric condition that is uncontrolled and/or untreated for a minimum of 6 months prior to the Screening Visit. Participants with a lifetime history of psychosis and/or mania.
History of suicidal behavior or major psychiatric disorder.
Current diagnosis or history of substance abuse; positive drug test at Screening.
History of moderate or severe head trauma or other neurological disorder (including seizure disorder) or systemic medical disease that is likely to affect central nervous system functioning.
Recent or planned surgery, requiring general anesthesia, <8 weeks prior to the Screening Visit.
Participant has had gastrointestinal surgery that interferes with physiological absorption and motility (i.e., gastric bypass, duodenectomy, or gastric banding).
Current diagnosis of viral hepatitis or a history of liver disease.
Conditions considered clinically relevant in the context of the study such as uncontrolled hypertension (high blood pressure), diabetes, a life-threatening allergy

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: Тройное слепое
Основная цель: Лечение