A Study of Oral Atogepant Tablets to Assess Adverse Events and Change in Disease Activity To Prevent Migraine in Participants Aged 12 to 17 Years

Официальное название

A Phase 3, Multicenter, 12-Week, Double Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Atogepant for the Preventive Treatment of Chronic Migraine in Pediatric Subjects 12 to 17 Years of Age

Обзор

Migraine is a disease that most often causes moderate to severe headache on one side of the head. A migraine attack is a headache that may be accompanied by throbbing, nausea, vomiting, sensitivity to light and sound, or other symptoms. The goals of the study are to evaluate adverse events and how well treatment of atogepant works compared to placebo (looks like the study treatment but contains no medicine) in preventing chronic migraine in participants between 12 and 17 years of age. Atogepant is a medicine currently approved in the United States and Europe for the preventive treatment of migraine in adult patients with migraine and is being studied for the preventative treatment of chronic migraine in participants between the ages of 12 and 17 years. Participants will be randomly assigned to one of the 2 groups to be treated with either atogepant or placebo. This study is double-blinded, which means that neither the patients nor the study doctors know who is given which study treatment. Approximately 420 participants 12 to 17 years of age with chronic migraine will be enrolled at approximately 70 sites across the world. Participants will receive oral tablets of atogepant or placebo once daily for 12 weeks and will be followed for 4 weeks. Participants will attend regular visits during the study at a hospital or clinic and the effects of treatment will be checked by completion of a daily diary, medical assessments, blood tests, checking for side effects, and completing questionnaires.

Вмешательства

• Препарат Atogepant
  Oral tablet
• Препарат Placebo for Atogepant
  Oral tablet

Первичные конечные точки

• Number of Participants Experiencing Adverse Events (AEs) [Срок оценки: Up to approximately 16 weeks]
• Change From Baseline in Mean Monthly Migraine Days [Срок оценки: Baseline (Week 0) through Week 12]

Вторичные конечные точки (5)

• Change From Baseline in Mean Monthly Headache Days [Срок оценки: Baseline (Week 0) through Week 12]
• Change From Baseline in Mean Monthly Acute Medication Use Days [Срок оценки: Baseline (Week 0) through Week 12]
• Percentage of Participants who Achieve at Least a 50% Reduction in 3-month Average of Monthly Migraine Days [Срок оценки: Baseline (Week 0) through Week 12]
• Change from Baseline in the Pediatric Quality of Life Inventory (PedsQL) Total Score [Срок оценки: Baseline (Week 0) through Week 12]
• Change From Baseline in the Pediatric Migraine Disability Assessment (PedMIDAS) Total Score [Срок оценки: Baseline (Week 0) through Week 12]

Критерии участия

Критерии включения

• History of chronic migraine with or without aura consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd Edition (ICHD-3) (2018) for at least 6 months as of Visit 1.
• During the last 28 days of the screening/baseline period, and as per eDiary:

• Participant must have completed the eDiary for a minimum of 20 out of 28 days.
• Participant has >= 15 headache days.
• Participant has >= 8 migraine days.

Критерии исключения

• Clinically significant hypertension per investigator's judgment.
• History of any clinically significant hematologic, endocrine, pulmonary, renal, hepatic, gastrointestinal, cardiovascular or neurologic disease.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

США · 31 центр

• Rehabilitation and Neurological Services /ID# 270782 — Huntsville
• Preferred Research Partners - Fayetteville /ID# 270419 — Fayetteville
• Preferred Research Partners /ID# 270389 — Little Rock
• Advanced Research Center /ID# 270257 — Anaheim
• Neuro Pain Research Center /ID# 271048 — Fresno
• Accellacare - Long Beach /ID# 270398 — Long Beach
• Excell Research /ID# 270258 — Oceanside
• Lumos Clinical Research Center /ID# 270582 — San Jose
• … и ещё 23 центра

Япония · 8 центров

• Konan Medical Center /ID# 270486 — Kobe
• Umenotsuji Clinic /ID# 270484 — Kochi
• Tominaga Clinic - Osaka /ID# 270483 — Osaka
• Tokyo Headache Clinic /ID# 271610 — Shibuya-ku
• Tokyo Medical University Hospital /ID# 270487 — Shinjuku-ku
• Tendo Brain Clinic /ID# 271410 — Tendo-shi
• Nagaseki Headache Clinic /ID# 271699 — Kai
• Tanaka Neurosurgery & Headache Clinic /ID# 271346 — Kagoshima

Польша · 5 центров

• Clinical Research Center Medic-R /ID# 270235 — Poznan
• Athleticomed Sp. z o.o /ID# 270243 — Bydgoszcz
• Specjalistyczne Gabinety Sp. z o.o /ID# 270238 — Krakow
• MIGRE Polskie Centrum Leczenia Migreny /ID# 270239 — Wroclaw
• Oha-Med Sp. Z O.O /ID# 270242 — Warsaw

Португалия · 5 центров

• Hospital da Luz /ID# 277991 — Lisbon
• Unidade Local de Saude de Almada-Seixal, EPE /ID# 278092 — Almada
• Unidade Local de Saude de Coimbra /ID# 277993 — Coimbra
• Unidade Local de Saude de Santa Maria /ID# 277997 — Lisbon
• Unidade Local de Saude de Santo Antonio /ID# 278090 — Porto

Великобритания · 4 центра

• Great Ormond Street Children's Hospital /ID# 271550 — London
• Medway Maritime Hospital /ID# 271885 — Gillingham
• Royal Aberdeen Children's Hospital /ID# 271664 — Aberdeen
• Stepping Hill Hospital-Stockport NHS foundation trust /ID# 271883 — Stockport

Канада · 2 центра

• London Health Sciences Centre - Victoria Hospital & Children's Hospital /ID# 270659 — London
• McGill University Health Centre - Glen Site /ID# 270662 — Montreal

Дания · 2 центра

• Herlev Hospital /ID# 270482 — Herlev
• Regionshospitalet Godstrup /ID# 270481 — Herning

Венгрия · 2 центра

• Semmelweis Egyetem /ID# 271219 — Budapest
• Rozsavolgyi Rendelo-Ceba Bt. /ID# 271500 — Budapest

Италия · 2 центра

• Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 270756 — Milan
• Ospedale Pediatrico Bambino Gesù /ID# 270759 — Rome

Нидерланды · 2 центра

• Canisius-Wilhelmina Ziekenhuis /ID# 270374 — Nijmegen
• HagaZiekenhuis /ID# 270379 — The Hague

Пуэрто-Рико · 1 центр

• Caribbean Medical Research Center Headlands /ID# 271300 — San Juan

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: NCT06810505 · M23-712 · 2024-513836-28 · 2024-513836-28-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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