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 210 人开始时间: 2017年1月17日最近更新: 2021年8月2日

适应症

试验速览

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•Patient is male or female aged between one and 65 years
•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 anesthetic 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 anesthesia 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 endpoint.
•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 less than 12 weeks prior to the screening visit.

发起方

GW Research Ltd.