NCT05772429进行中（未招募）不适用
Long-term Follow-up of a Multicentre, Non-interventional, Prospective Cohort of Participants Prescribed Epidyolex in France in a Real-life Setting
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 158
- 试验地点
- 29
- 主要终点
- Retention Rate Percentage After Initiation of Treatment With Epidyolex
研究概览
简要总结
This is a multi-center, non-interventional and prospective study of patients receiving Epidyolex as part of standard clinical practice in France. The study will state an overview of patient characteristics and clinical history (including age, sex, diagnosis, duration of epilepsy, predominant seizure type, previous medications, current co-medications and Epidyolex dose), and an evaluation of retention rates, safety profile, seizure activity, changes in executive function and quality of life measured in a 2-year follow-up period.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals for whom treatment with Epidyolex has been initiated by a physician with experience in the treatment of epilepsy.
- •The participant and/or parent(s)/legal representative is willing and able to give informed consent/assent for participation in the study.
排除标准
- •Previously initiated with Epidyolex before the start of the study (especially during the French early access program (EAP)).
研究组 & 干预措施
Epidyolex
Participants will receive Epidyolex in accordance with their routine clinical practice as prescribed by their physician.
干预措施: Epidiolex (Drug)
结局指标
主要结局
Retention Rate Percentage After Initiation of Treatment With Epidyolex
时间窗: Up to 24 months post-dose.
Retention rate will be measured through assessing the frequency of seizures and the length of time on treatment before a seizure event.
次要结局
- Percent Change From Baseline in Seizure Frequency (Average Per 28 Days)(Up to 24 months post-dose.)
- Change From Baseline in Behavior Rating Inventory of Executive Function, Adult Version (BRIEF- A) Score in Participants Aged >18 Years(Baseline; Up to 24 months post-dose.)
- Maximum Dose of Epidyolex Administered to Participants(Up to 24 months post-dose.)
- Change From Baseline in Behavior Rating Inventory of Executive Function (BRIEF) Score in Participants Aged 6 to 18 Years(Baseline; Up to 24 months post-dose.)
- 100% Responder (Seizure Freedom) Rate(Up to 24 months post-dose.)
- Number of Seizure-Free Days (Average Per 28 Days)(Up to 24 months post-dose.)
- Longest Duration of Seizure-Free Days in the Last 28 Days(Up to 24 months post-dose.)
- Change From Baseline in Behavior Rating Inventory of Executive Function, Preschool Version (BRIEF-P) Score in Participants Aged ≤5 Years(Baseline; Up to 24 months post-dose.)
- 50% Responder Rate(Up to 24 months post-dose.)
- Modal Dose of Epidyolex Administered to Participants(Up to 24 months post-dose.)
- Change from Baseline in Average Daily Dosage of Concomitant Anti-Epileptic Drugs (AEDs) and Other Medicines(Up to 24 months post-dose.)
- Use of Rescue Medication Per Month(Up to 24 months post-dose.)
- Physician Global Clinical Impression of Change (PGIC) Score(Up to 24 months post-dose.)
- 75% Responder Rate(Up to 24 months post-dose.)
- Caregiver Global Impression of Change (CGIC) Score(Up to 24 months post-dose.)
- Change from Baseline in Health Utility Index Mark II (HUI-2) Score(Up to 24 months post-dose.)
研究者
研究点 (29)
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