A Double Blind, Randomized, Placebo-controlled, Two-part Study to Investigate the Pharmacokinetics, Followed by Efficacy and Safety of GWP42006 as add-on Therapy in Patients With Inadequately Controlled Focal Seizures.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 162
- 主要终点
- Percentage change from baseline to the end of treatment in focal seizure frequency in subjects taking GWP42006 compared to placebo.
研究概览
简要总结
To investigate the potential antiepileptic effects of GWP42006 as add-on therapy in subjects with inadequately controlled focal seizures.
详细描述
This is a double blind, randomized, placebo controlled, two-part study. Part B only will be described in this record.
Subjects who satisfy all inclusion and none of the exclusion criteria will enter a four-week baseline period, followed by a two-week dose escalation period (400 mg twice daily for one week, then 600 mg twice daily for one week), a six-week stable treatment period (800 mg twice daily) and a 12-day taper period. Subjects will be required to attend eight study visits. A follow-up phone call will take place four weeks after last dose.
Subjects will be randomized to receive in a 1:1 ratio, GWP42006 or placebo. Subjects will be required to record a daily diary with information about their seizures, investigational medicinal product (IMP) and concomitant antiepileptic drug (AED) administration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
GWP42006
GWP42006
干预措施: GWP42006 (Drug)
Placebo control
Placebo
干预措施: Placebo Control (Drug)
结局指标
主要结局
Percentage change from baseline to the end of treatment in focal seizure frequency in subjects taking GWP42006 compared to placebo.
时间窗: Day -28 to Day 57
次要结局
- Number of subjects considered treatment responders.(Day -28 to Day 57)
- Change from baseline in seizure subtypes frequency.(Day -28 to Day 57)
- Change from baseline in composite seizure score.(Day -28 to Day 57)
- Change from baseline in the number of focal seizure free days.(Day -28 to Day 57)
- Change from baseline in the usage of rescue medication.(Day -28 to Day 57)
- Subject Global Impression of Change (SGIC).(Day 57)
- Physician Global Impression of Change (PGIC) at the end of treatment.(Day 57)
- The incidence of adverse events as a measure of subject safety.(Day -28 to Day 96)