EUCTR2015-002939-18-ES进行中（未招募）1 期
A phase 2, double-blind, randomized, placebo-controlled pharmacokinetic trial in two parallel groups to investigate possible drug- drug interactions between stiripentol or valproate and GWP42003-P in patients with epilepsy.
GW Research Ltd.0 个研究点目标入组 40 人开始时间: 2016年1月13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
- 40
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
入选标准
- •For inclusion in the trial patients must fulfil ALL of the following criteria:
- •6.1.1Male or female patients aged 16 to 55 years inclusive.
- •6.1.2Patient must be taking STP (for the STP arm) or VPA (for the VPA arm) and no more than two other AEDs during the blinded period of the trial.
- •-In the VPA arm only, the patient must not be receiving STP (VPA allowed in STP arm).
- •6.1.3AED doses, including STP or VPA, must be stable for four weeks prior to screening and regimen must remain stable throughout the duration of the blinded period of the trial.
- •6.1.4Patient must have a documented magnetic resonance imaging/computerized tomography of the brain that ruled out a progressive neurologic condition.
- •6.1.5Patient must have experienced at least one countable uncontrolled seizures of any type (i.e., tonic-clonic, tonic, clonic, atonic, partial onset or focal: focal seizures with retained consciousness and a motor component, focal seizures with impaired consciousness, focal seizures evolving to bilateral secondary generalization) within two months prior to randomization.
- •6.1.6Intervention with vagus nerve stimulation (VNS) and/or ketogenic diet must be stable for four weeks prior to baseline and the patient must be willing to maintain a stable regimen during the blinded period of the trial.
- •6.1.7Patients must abstain from alcohol during the blinded period of the trial.
- •6.1.8Patient and legal representative (if required) is available to attend all PK visits within the required visit window.
- •6.1.9Patient and legal representative (if required) must be willing and able to give informed consent/assent for participation in the trial.
- •6.1.10Patient must be willing and able (in the investigator?s opinion) to comply with all trial requirements.
- •6.1.11Patient is willing for his or her name to be notified to the responsible authorities for participation in this trial, as applicable.
- •6.1.12Patient is willing to allow his or her primary care practitioner and consultant, if appropriate, to be notified of participation in the trial.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 35
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 25
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •The patient may not enter the trial if ANY of the following apply:
- •6.2.1Patient has clinically significant unstable medical conditions other than epilepsy.
- •6.2.2Patient has a history of symptoms (e.g., dizziness, light-headedness, blurred vision, palpitations, weakness, syncope) related to a drop in blood pressure due to postural changes (orthostatic blood pressure changes).
- •6.2.3Any history of suicidal behavior or any suicidal ideation of type four or five on the C-SSRS in the last month or at screening.
- •6.2.4Patient has had clinically relevant symptoms or a clinically significant illness in the four weeks prior to screening or enrollment, other than epilepsy.
- •6.2.5Patient is currently using Felbamate and has been taking it for less than 12 months prior to screening.
- •6.2.6Patient has consumed alcohol during the seven days prior to enrollment and is unwilling to abstain during the blinded period of the trial.
- •6.2.7Patient is currently using or has in the past used recreational or medicinal cannabis, or synthetic cannabinoid based medications (including Sativex®) within the three months prior to trial entry or is unwilling to abstain for the duration of the trial.
- •6.2.8Patient has any known or suspected history of any drug abuse or addiction.
- •6.2.9Patient has consumed grapefruit or grapefruit juice seven days prior to enrollment and is unwilling to abstain from drinking or eating grapefruit within seven days of PK visits.
- •6.2.10Patient has any known or suspected hypersensitivity to cannabinoids or any of the excipients of the IMP, e.g., sesame oil.
- •6.2.11Female patient of child bearing potential, or male patient?s partner is of child bearing potential, unless willing to ensure that they or their partner use a highly effective method of birth control (e.g., hormonal contraceptives, intrauterine devices/hormone-releasing systems, bilateral tubal occlusion, vasectomized partner, sexual abstinence) during the trial and for three months thereafter.
- •6.2.12Female patient who is pregnant (positive pregnancy test), lactating or planning pregnancy during the course of the trial and for three months thereafter.
- •6.2.13Patient who has received an IMP within the 12 weeks prior to the screening visit.
- •6.2.14Any other significant disease or disorder which, in the opinion of the investigator, may either put the patient at risk because of participation in the trial, may influence the result of the trial, or the patient?s ability to participate in the trial.
- •6.2.15Following a physical examination, the patient has any abnormalities that, in the opinion of the investigator, would prevent the patient from safe participation in the trial.
- •6.2.16Patient has significantly impaired hepatic function, as determined at screening (Visit 1) or enrollment (Visit 2) defined as any of the following:
- •-Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST)
- •>5 × upper limit of normal (ULN).
- •-ALT or AST >3 x ULN and (total bilirubin [TBL] >2 × ULN or
- •international normalized ratio [INR] >1.5).
- •-ALT or AST >3 x ULN with the presence of fatigue, nausea, vomiting, right upper quadrant pain or tendern
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