Effect of Sativex on neuropathic pain and spasticity following spinal cord injury

Spinal Cord Injury Centre of Western Denmark0 个研究点开始时间: 2013年4月16日最近更新: 2014年8月5日

试验速览

暂无简介。

•Neuropathic pain and / or spasticity after spinal cord injury / disease duration of at least 3 months, spinal cord injury must be at least 6 months prior to enrollment. The average intensity of the pain, respectively. spasticity measured on a numerical rating scale (NRS) (0-10) must be at least 4 in the baseline period (1 week). Age 18 years. Given informed consent.
•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 50
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 10

•History of stroke or cerebral contusion or other cerebral injury with significant sequelae.
•Patients who can’t cooperate or unable to complete the project due to lack of understanding of Danish
•Pregnant or lactating women. Woman and men (or their partners) must use contraceptives during and three months after the trial has ended.
•Known allergy to cannabinoids (THC / CBD) or excipients.
•Previous or current schizophrenia, psychosis or other serious psychiatric disorder other than depression in the patient or immediate family.
•Concomitant severe pain that can’t be distinguished from the neuropathic pain associated with spinal cord injury
•Terminal illness or patients inappropriate for placebo.
•Planned surgery, anesthesia or travel abroad during the trial.
•History of severe cardiovascular disease, treatment with digoxin, poorly controlled hypertension, epilepsy or history of seizures
•Significant impairment of liver or kidney.
•There should not be use of cannabinoids 3 months before the study or during the study.
•Abuse of cannabinoids, alcohol or medication. Patients who are in Antabus treatment should be excluded from the study due to interaction risk because Sativex contains alcohol.

发起方

Spinal Cord Injury Centre of Western Denmark