The effect of medical cannabis on neuropathic pain and spasticity in patients with Multiple Sclerosis and in patients with spinal cord injury. A multicenter national placebo-controlled trial - The effect of medical cannabis on neuropathic pain and spasticity in patients with MS and SCI

Aarhus Universitetshospital0 个研究点目标入组 448 人开始时间: 2018年7月9日最近更新: 2020年11月23日

适应症

试验速览

暂无简介。

•1)Probable or definite neuropathic pain in more than three months with a mean baseline pain intensity NRS >3 and < 9 and/or spasticity severity NRS > 3.
•2)Stable disease (MS and SCI)
•3)Age = 18 years
•4)Written Informed consent
•5)Reliable contraception for fertile women
•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 368
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 80

•1) Other pain conditions (e.g. diabetic neuropathy), which cannot be distinguished from central pain in MS and/or SCI
•2) Current treatment with opioids
•3) Severe Psychiatric disorder in patient or biological family (except well-treated depression)
•4) History of suicidal
•5) Pregnant or lactating women
•6) Significant impairment of liver or kidney.
•7) History of severe cardiovascular disease
•8) History of seizures or epilepsy
•9) Active Cancer disease
•10) Abuse of cannabinoids, alcohol or medication.
•11) There should not be use of cannabinoids 3 months before the study or during the study.

发起方

Aarhus Universitetshospital