EUCTR2021-001959-13-IT进行中（未招募）1 期
Adjunctive cannabidiol therapy in patients with CDKL5 deficiency disorder. Interventional drug study on efficacy and safety with focus on seizure effects - EPICDKL5
FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE0 个研究点目标入组 15 人开始时间: 2021年7月27日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Male and female patients aged =1 year and = 30 years
- •Patients with a confirmed diagnosis of CDKL5 deficiency disorder
- •Patients with = 4 motor seizures/month in the last 6 months at baseline
- •Patients with 12-week baseline seizure frequency data available either from seizure diaries or medical records
- •Based on the physician's clinical judgment, seizures not adequately controlled with the current treatment
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 3
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients on an investigational drug or device within 30 days prior to the initiation of the present study
- •Patients on an artisanal cannabis derivative treatment
- •Patients with severe hepatic impairment
- •Patients contraindicated for cannabidiol use (according to SmPC), including suspected sesame seed allergy or history of hypersensitivity to cannabidiol or any ingredients in the product
- •Pregnant or lactating females
研究者
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