A Phase 2, Double-blind, Randomized, Placebo-controlled Pharmacokinetic Trial in 2 Parallel Groups to Investigate Possible Drug-drug Interactions Between Stiripentol or Valproate and GWP42003-P in Patients With Epilepsy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 5
- 主要终点
- Number of participants who experienced an adverse event.
研究概览
简要总结
This trial consists of 2 parts: a double-blinded phase and an open-label extension phase. The open-label extension phase only will be described in this record. All participants will receive the same dose of GWP42003-P. However, investigators may subsequently decrease or increase the participant's dose until the optimal dose is found.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 55 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant must have a documented magnetic resonance imaging/computerized tomography of the brain that ruled out a progressive neurologic condition.
排除标准
- •Participant has clinically significant unstable medical conditions other than epilepsy.
- •Participant has a history of symptoms related to a drop in blood pressure due to postural changes (e.g., dizziness, light-headedness, blurred vision, palpitations, weakness, syncope).
- •Participant has any history of suicidal behavior or any suicidal ideation of type 4 or 5 on the C-SSRS in the last month.
- •Participant is currently using felbamate and has been taking it for less than 12 months prior to screening visit of the blinded phase of the trial.
- •Participant is currently using or has in the past used recreational or medicinal cannabis, or synthetic cannabinoid-based medications (including Sativex®) within the 3 months prior to trial entry.
- •Participant has any known or suspected history of any drug abuse or addiction.
- •Participant is unwilling to abstain from recreational or medicinal cannabis, or synthetic cannabinoid-based medications (including Sativex) for the duration for the trial.
- •Participant has any known or suspected hypersensitivity to cannabinoids or any of the excipients of the Investigational Medicinal Product (IMP), e.g., sesame oil.
研究组 & 干预措施
GWP42003-P
Administered orally, twice daily (morning and evening), commencing with titration of 100 mg/mL GWP42003-P to 20 mg/kg/day over 10 days in a blinded manner (i.e., only participants taking placebo in the blinded phase will up-titrate; doses will remain unchanged for those taking GWP42003-P in the blinded phase).
Participants remain on the maintenance dose for the remainder of the 48-week treatment period, until early withdrawal or at an early study conclusion date defined by the sponsor. However, investigators may subsequently decrease or increase the participant's dose (to a maximum of 30 mg/kg/day) until the optimum dose is found.
Dosing is tapered (10% each day) for participants who do not immediately continue to use GWP42003-P once market authorization is granted, or for those who withdraw early.
干预措施: GWP42003-P (Drug)
结局指标
主要结局
Number of participants who experienced an adverse event.
时间窗: Up to 48 weeks.
The number of participants who experienced an adverse event during the trial is presented.
次要结局
- Number of participants with a clinically significant change in physical examination.(Up to 48 weeks.)
- Number of participants with a clinically significant change in 12-lead electrocardiogram (ECG).(Up to 48 weeks.)
- Number of participants with a clinically significant change in serum biochemistry.(Up to 48 weeks.)
- Number of participants with a clinically significant change in hematology.(Up to 48 weeks.)
- Number of participants with a treatment-emergent suicidality flag.(Up to 48 weeks.)
- Number of participants with a clinically significant change in urinalysis.(Up to 48 weeks.)
- Number of participants with a clinically significant change in vital signs.(Up to 48 weeks.)
- Seizure frequency by subtype.(Up to 48 weeks.)
- Number of participants with a treatment-emergent finding indicative of drug abuse liability.(Up to 48 weeks.)