ACTRN12618000545268已完成2 期
A Randomised, Double Blind, Placebo-Controlled, Crossover Trial of Tetrahydrocannabinol and Cannabidiol for the treatment of Tourette’s Syndrome
Wesley Medical Research Insititute0 个研究点目标入组 22 人开始时间: 2018年4月12日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 22
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 70 Years(—)
- 性别
- All
入选标准
- •Confirmed diagnosis of Tourette's syndrome with a tic severity score greater than 20 on the Yale Global Tic Severity Scale.
- •Must agree not to drive a motor vehicle during the trial.
- •Able to give written and informed consent.
排除标准
- •History of epilepsy.
- •History of multiple sclerosis.
- •History of an additional movement disorder such as Parkinson's disease.
- •History of dementia..
- •Pregnancy and breastfeeding.
- •Recreational cannabis smoker (participants must have a negative drug screen at study entry).
- •Current treatment with deep brain stimulation.
- •Current drug or alcohol abuse (excluding tobacco).
- •Any history of psychosis.
- •Diagnosis of bipolar disorder.
- •History of any previous high-lethality suicide attempt, history of any suicide attempt in the last 12-months or at high-risk of suicide in the opinion of the screening clinician.
- •Currently using antipsychotic or dopamine-depleting agents as treatment for Tourette's syndrome. Participants who have undergone a successful 4 week washout of current exclusionary therapies overseen by the Investigator will be eligible.
- •Allergy to tetrahydrocannabinol and cannabidiol or the tablet excipients.
- •Taken another study (experimental) drug within the past 30 days.
研究者
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