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. - MUSEC study

Gesellschaft fuer klinische Forschung e.V. (Society for Clinical Research)0 个研究点目标入组 300 人开始时间: 2005年12月9日最近更新: 2019年11月25日

适应症

试验速览

暂无简介。

•-Signed informed consent.
•-Diagnosis of MS according to McDonald criteria.
•-Current muscle stiffness =4 on a 11-point categorical rating scale.
•-On-going troublesome muscle stiffness for at least 3 months before enrolling in the trial.
•-Stable disease for the previous 6 months in the opinion of the treating physician.
•-Antispasticity medication and physiotherapy stabilised for the last 30 days.
•-Patients may be ambulatory or not.
•-Age 18-64.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years)
•F.1.3.1 Number of subjects for this age range

•-Immunosuppressants which may affect spasticity (including corticosteroids and interferon but excluding azathioprine) taken currently or in previous 30 days
•-Past or present history of psychotic illness.
•-Open / infected pressure sores or other source of chronic infection.
•-Significant fixed tendon contractures.
•-Severe cognitive impairment such that the patient is unable to provide informed consent.
•-History of clinically important renal, cardiovascular or neurol. diseases (apart from MS).
•-Malignancy within the past 2 years.
•-Cannabinoids taken currently or in previous 30 days.
•-Positive qualitative urinary test on cannabinoids at screening visit. (In this case a patient will be allowed to repeat the test at a second screening visit later.)
•-Known hypersensitivity to cannabinoids.
•-Current drug abuse, including alcohol abuse.
•-Laboratory parameters outside the following limits:
•Creatinine> 3x upper limit of normal
•Bilirubine> 3x upper limit of normal
•Transaminases> 5 x upper limit of normal
•-Anticipated immunisations within the 12 weeks of trial participation.
•-Other problems likely to make participation difficult at the discretion of the neurologist.
•-Women who are pregnant, lactating or not using adequate contraception.
•-Participation in other treatment studies currently or within the previous month.

发起方

Gesellschaft fuer klinische Forschung e.V. (Society for Clinical Research)