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Идёт набор NCT07233239

A Study to Evaluate the Efficacy and Safety of Cannabidiol Oral Solution (CBD-OS [GWP42003-P, JZP926]) for the Treatment of Focal-Onset Seizures

Фаза I С лечением Focal Seizures

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: CBD-OS.
Кому может быть актуально
Состояния в реестре: Focal Seizures. Базовые параметры: 12 лет — 75 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
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A Phase 1b, Multicenter, Open-Label, Single-arm Study to Evaluate the Efficacy and Safety of Cannabidiol Oral Solution (CBD-OS [GWP42003-P, JZP926]) in Participants Aged 12 to 75 Years for the Treatment of Focal-Onset Seizures

Обзор

Cannabidiol oral solution (CBD-OS) is approved in the US for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome (DS), or Tuberous sclerosis complex (TSC) in patients 1 year of age and older. This study will assess the efficacy and safety of CBD-OS in participants aged 12 to 75 years for the treatment of focal-onset seizures (FOS).

Подробное описание

This study will assess the efficacy of CBD-OS as an adjunctive treatment in reducing the frequency of focal seizures compared to baseline as well as the effect of CBD-OS on health outcome endpoints in early line and refractory participants with FOS. This study will also examine pharmacokinetics (PK), safety, and potential predictors or mediators of treatment response, including functional magnetic resonance imaging (fMRI) and neuropsychological testing in a substudy.

Вмешательства

  • Препарат CBD-OS
    Starting dose of CBD-OS will be administered as per the approved local product label

Первичные конечные точки

  • Percent change in countable focal seizure frequency compared to baseline [Срок оценки: Baseline up to 16 weeks]

Критерии участия

Participants are eligible to be included in the main study only if all of the following criteria apply:

  • Participant has a documented diagnosis of focal epilepsy according to the ILAE Classification of Epilepsy, 2017, characterized by focal seizure types with typical interictal/ictal EEG findings (eg, history of an EEG with focal sharp waves or slowing). Participants with a documented diagnosis of focal epilepsy and a normal EEG are eligible for inclusion.
  • Participant is currently treated with at least 1, but no more than 4, antiseizure medications on a stable regimen.
  • Participant is aged 12 to 75 years old, inclusive, at Screening.

Participants are excluded from the study if any of the following criteria apply:

  • Has a concurrent, confirmed diagnosis of non-epileptic seizures or events that can confound the assessment of the efficacy measures, in the opinion of the investigator.
  • Has clinically significant unstable medical condition(s), other than epilepsy.
  • History of suicidal behavior, current suicidal risk as determined from history, or presence of active suicidal ideation as indicated by a positive response to Item 4 or Item 5 on the C-SSRS or is considered at risk of suicide or self-harm based on the clinical judgement of the investigator following interview with the participant and/or caregiver.
  • Has known or suspected hypersensitivity to cannabinoids or any of the excipients of the study intervention, such as sesame oil.
  • Is currently treated with Epidiolex or received treatment with Epidiolex within 28 days prior to Screening (Visit 1).
  • Is currently using or has used recreational or medicinal cannabis, cannabinoid/CBD based medications, products, or supplements (botanical or synthetic) within 28 days prior to Screening (Visit 1) and/or is unwilling to abstain for the duration of the study.
  • Presence of only nonmotor focal aware seizures or primary generalized epilepsies.

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 · 24 центра
  • Banner University Medical Center-Phoenix — Phoenix
  • UC San Diego — La Jolla
  • Yale University — New Haven
  • University of South Florida — Tampa
  • Emory University — Atlanta
  • Savannah Neurology Specialists — Savannah
  • Northwestern University — Chicago
  • Mid-Atlantic Epilepsy and Sleep Center — Bethesda
  • … и ещё 16 центров

Идентификаторы

NCT: NCT07233239 · JZP926-105

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗