A double-blind, randomized, placebo-controlled study to investigate the efficacy and safety of cannabidiol (GWP42003-P, CBD) as add-on therapy in patients with tuberous sclerosis complex who experience inadequately-controlled seizures

GW Research Ltd.0 个研究点目标入组 224 人开始时间: 2016年11月18日最近更新: 2022年1月24日

适应症

试验速览

暂无简介。

•Patient is male or female aged between one and 65 years inclusive
•Patient and/or parent(s)/legal representative is willing and able to give informed consent/assent for participation in the study.
•Well-documented clinical history of epilepsy which is not completely controlled by their current AEDs.
•Clinical diagnosis of TSC according to criteria agreed by the 2012 International Tuberous Sclerosis Complex Consensus Conference.
•Taking one or more AEDs at a dose which has been stable for at least four weeks prior to screening.
•All medications or interventions for epilepsy (including ketogenic diet and any neurostimulation devices for epilepsy) must have been stable for one month prior to screening and the patient is willing to maintain a stable regimen throughout the study.
•At the end of the baseline period patients must also meet the following criterion:
•Completed at least 90% of calls to IVRS during the first 28 days of the baseline period (a minimum of 25 completed calls).
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 94
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 116
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Patient has a history of pseudo-seizures.
•Patient has undergone general aesthetic in the four weeks prior to screening or randomization.
•Patient has undergone surgery for epilepsy in the six months prior to screening.
•Patient is being considered for epilepsy surgery or any procedure involving general anaesthesia during the blinded phase of the study.
•Patient has been taking felbamate for less than one year prior to screening.
•Patient is taking an oral mTOR inhibitor.
•Patient is currently using or has in the past used recreational or medicinal cannabis, or cannabinoid-based medications, within the three months prior to screening and is unwilling to abstain for the duration for the study.
•Patient has tumor growth which, in the opinion of the Investigator, could affect the primary
•Patient is female and of child bearing potential, or is male whose 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 study and for three months thereafter.
•Female patient who is pregnant (positive pregnancy test), lactating or planning pregnancy during the course of the study and for three months thereafter.
•Patient has received an IMP as part of a clinical trial less than 12 weeks prior to the screening visit.

发起方

GW Research Ltd.