ISRCTN42223114已完成不适用

MUltiple Sclerosis and Extract of Cannabis (MUSEC): a randomised, double-blind, placebo-controlled phase III trial to determine the efficacy and safety of a standardised oral extract of Cannabis sativa for the symptomatic relief of muscle stiffness and pain in Multiple Sclerosis (MS)

Institute for Clinical Research (Institut fur klinische Forschung) (Germany)0 个研究点目标入组 400 人开始时间: 2007年10月17日最近更新: 2015年1月13日

适应症

试验速览

暂无简介。

•1. Diagnosis of MS according to McDonald criteria
•2. Current muscle stiffness greater than or equal to 4 on a 11-point categorical rating scale
•3. On-going troublesome muscle stiffness for at least 3 months before enrolling in the trial
•4. Stable disease for the previous 6 months in the opinion of the treating physician
•5. Antispasticity medication and physiotherapy stabilised for the last 30 days
•6. Patients may be ambulatory or not
•7. Age 18 - 64 years

•1. Immunosuppressants which may affect spasticity (including corticosteroids and interferon but excluding azathioprine) taken currently or in previous 30 days
•2. Open/infected pressure sores or other source of chronic infection
•3. Significant fixed tendon contractures
•4. Cannabinoids taken currently or in previous 30 days
•5. Positive qualitative urinary test on cannabinoids at screening visit
•6. Laboratory parameters outside the following limits:
•6.1. Creatinine greater than 3 x upper limit of normal
•6.2. Bilirubin greater than 3 x upper limit of normal
•6.3. Transaminases greater than 5 x upper limit of normal

发起方

Institute for Clinical Research (Institut fur klinische Forschung) (Germany)