Qudexy XR for the Prevention of Migraine in Children 6 to 11 Years Old

Официальное название

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 4 Study to Evaluate the Efficacy and Safety of Qudexy(R) XR in the Prevention of Migraine in Children 6 to 11 Years of Age

Обзор

A Phase 4 study to evaluate Qudexy XR for the prevention of migraine in children 6 to 11 years of age.

Вмешательства

• Препарат Qudexy XR
  Extended-Release Capsule
• Препарат Placebo
  Qudexy XR Matching capsules

Первичные конечные точки

• Change from Baseline (last 28 days Run-In Period) in the monthly number of headache days during the 8-week Maintenance Period based on the diary. [Срок оценки: 16 Weeks]

Критерии участия

Критерии включения

• Subject is a female or male 6 to 11 years of age, inclusive, at Visit 1 (Screening)
• Subject weighs at least 17.0 kg and less than 50.0 kg at Visit 1 (Screening) based on 95 percentile weight for the age range.11
• Subject has at least a 6-month history of headaches consistent with a diagnosis of migraine with or without aura (International Classification of Headache Disorders, 3rd Edition \[ICHD 3\]).
• Subject had ≥8 self-reported headache days in the 28 days prior to Screening.
• Subject has a PedMIDAS score >10, indicating at least mild disruption in daily activities, and <140, indicating extreme disability that may require more comprehensive, multi component therapy.

Критерии исключения

• Subject has continuous migraines, defined as an unrelenting headache for a 28-day period.
• Subject is currently receiving treatment or has used Botulinum toxin (Botox®) within 3 months prior to Visit 1 (Screening).
• Subject is currently receiving migraine prevention medication and has initiated or changed the dose within 28 days of Screening or is unwilling to avoid making a change during the duration of the study.
• Subject has previously failed an adequate trial of topiramate (at least 3 months duration at a clinically appropriate dose) for prophylaxis of migraine headache due to lack of efficacy or AEs.
• Subject has previously failed an adequate trial of >3 migraine preventative medications.
• Subject has a known history of allergic reaction to topiramate or any excipient in Qudexy XR.
• Subject has a diagnosis or history of disease that may interfere with safety or evaluation of the study drug.
• Subject is currently using an investigational drug or device or has used such within 30 days prior to Visit 1.
• Subject has begun menses and any of the following:

• Subject has tested positive for pregnancy; OR
• Subject is pregnant, planning pregnancy, or lactating; OR
• Subject is taking an oral hormonal contraceptive (either combined \[estrogen and progestogen containing\] or progestogen-only) and is unable or unwilling to switch to an alternative highly effective contraceptive method.

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 · 15 центров

• Upsher-Smith Clinical Trial Site #5 — Birmingham
• Upsher-Smith Clinical Trial Site #15 — La Jolla
• Upsher-Smith Clinical Trials Site #3 — Aurora
• Upsher-Smith Clinical Trial Site #1 — Stamford
• Upsher-Smith Clinical Trial Site #12 — Loxahatchee Groves
• Upsher-Smith Clinical Trial Site #8 — Orlando
• Upsher-Smith Clinical Trial Site #14 — Tampa
• Upsher-Smith Clinical Trial Site #2 — Ann Arbor
• … и ещё 7 центров

Идентификаторы

NCT: NCT04748601 · P255-501

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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