Long-term Safety Study of Rimegepant in Pediatric Subjects for the Acute Treatment of Migraine

Официальное название

Phase 3, Multicenter, Open-label Study to Assess the Long-term Safety and Tolerability of Rimegepant for the Acute 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 long-term safety of rimegepant in the acute treatment of migraine in children and adolescents (≥ 6 to \< 18 years of age).

Вмешательства

• Препарат Rimegepant (PF-07899801)
  Rimegepant 75 mg, 50 mg or 35 mg ODT

Первичные конечные точки

• The frequency and severity of on-treatment and treatment-emergent adverse events, serious adverse events, adverse events leading to discontinuation, clinically significant lab abnormalities [Срок оценки: 58 weeks]

Вторичные конечные точки (1)

• The frequency and severity of hepatic-related adverse events and frequency of hepatic-related adverse events leading to treatment discontinuation [Срок оценки: 58 weeks]

Критерии участия

Критерии включения

• History of migraine (with or without aura) for ≥ 6 months before Screening.
• History of 1 to 8 moderate or severe attacks per month during the 2 months prior to screening.
• 1 or more migraine days requiring treatment during the Observation Phase.
• Prophylactic migraine medication is permitted if the dose has been stable for at least 12 weeks prior to the Screening Visit.
• Ability to distinguish between migraine and other types of headaches.
• Weight > 15 kg. For EU countries only: Participants 12 to < 18 years of age must have a body weight of >25kg.
• Adequate venous access for blood sampling.
• Male and female participants 6 to < 18 years of age (participants must not reach their 18th birthday on or before the Baseline visit).

Критерии исключения

• History of cluster headache or hemiplegic migraine headache.
• Confounding and clinically significant pain syndrome.
• Current uncontrolled and/or untreated psychiatric condition for a minimum of 6 months prior to the Screening Visit (lifetime history of psychosis and/or mania are excluded).
• History of suicidal behavior or at risk of self-harm/harm to others.
• History of major psychiatric disorder.
• Current diagnosis or history of substance abuse
• Reported current use of or tested positive at Screening for drugs of abuse.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 115 центров

• Perseverance Research Center, LLC — Scottsdale
• Physicians Research Group — Tempe
• Advanced Research Center, Inc. — Anaheim
• ProScience Research Group — Culver City
• Neuro-Pain Research Center — Fresno
• Altman Clinical and Translational Research Institute, University of California San Diego — La Jolla
• Adult & Child Neurology Medical Associates — Long Beach
• Memorialcare Miller Children's & Women's Hospital Long Beach — Long Beach
• … и ещё 107 центров

Польша · 6 центров

Список центров уточняется — проверьте первичный протокол.

Испания · 3 центра

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT04743141 · BHV3000-312 · C4951003 · 2024-512744-32-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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