Effect of Sativex on pain and spasticity following spinal cord injury
- Conditions
- europathic pain and spasticity following spinal cord injuryMedDRA version: 14.1Level: LLTClassification code 10054095Term: Neuropathic painSystem Organ Class: 100000004852MedDRA version: 14.1Level: LLTClassification code 10041416Term: SpasticitySystem Organ Class: 100000004852MedDRA version: 14.1Level: PTClassification code 10041552Term: Spinal cord injurySystem Organ Class: 10022117 - Injury, poisoning and procedural complicationsTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2012-005328-14-DK
- Lead Sponsor
- Spinal Cord Injury Centre of Western Denmark
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Primary purpose is to study the effect of Sativex on neuropathic pain and spasticity following spinal cord injury.;Secondary Objective: Secondary objectives are to evaluate different pain and spasticity measures the effect on allodynia and hyperalgesia and impact on activities, mood, sleep and escape medication, after the use of Sativex.;Primary end point(s): The difference in mean value of patients daily rating of average pain intensity on NRS (0-10) in the last 7 days of each treatment period. Change from baseline to the last week of each treatment period.;Timepoint(s) of evaluation of this end point: baseline and 6 weeks treament
- Secondary Outcome Measures
Name Time Method Secondary end point(s): - Combined pain and spasticity score<br>- Pain relief (overall, at-level and below-level) and reduction of spasticity after each treatment period. For spasticity noted the overall and separately for spasms and stiffness<br>-Number of patients with 33% and 50% reduction of pain and/or spasticity.<br>- The effect on various pain symptoms assessed by a questionnaire on neuropathic pain (NPSI)<br>- Allodynia and hyperalgesia (mechanical, cold and warm)<br>- Sleep disturbance<br>- Use of escape medication<br>- Spasticity with use of Tardieu Scale, Clonus assessment, Spasms rated on NRS and the Penn Spasm Frequency Scale<br>- Global impression of change and preference period<br>- Number of responders, patients with 33% pain relief, in the group of patients with allodynia compared with the group without allodynia<br>- Pain and spasticity impact on activities, mood and sleep<br>- Adverse effects;Timepoint(s) of evaluation of this end point: baseline and 6 weeks treament