Neuropathic pain and spasticity following spinal cord injury MedDRA version: 14.1 Level: LLT Classification code 10054095 Term: Neuropathic pain System Organ Class: 100000004852 MedDRA version: 14.1 Level: LLT Classification code 10041416 Term: Spasticity System Organ Class: 100000004852 MedDRA version: 14.1 Level: PT Classification code 10041552 Term: Spinal cord injury System Organ Class: 10022117 - Injury, poisoning and procedural complications
Conditions
Interventions
Trade Name: Sativex, Oromucosal Spray
Product Name: Sativex, Oromucosal Spray
Product Code: 47794
Pharmaceutical Form: Oromucosal spray, solution
Pharmaceutical form of the placebo: Oromucosal spray,
Sponsors
Spinal Cord Injury Centre of Western Denmark
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Combined pain and spasticity score - 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 -Number of patients with 33% and 50% reduction of pain and/or spasticity. - The effect on various pain symptoms assessed by a questionnaire on neuropathic pain (NPSI) - Allodynia and hyperalgesia (mechanical, cold and warm) - Sleep disturbance - Use of escape medication - Spasticity with use of Tardieu Scale, Clonus assessment, Spasms rated on NRS and the Penn Spasm Frequency Scale - "Global impression of change" and preference period - Number of "responders", patients with 33% pain relief, in the group of patients with allodynia compared with the group without allodynia - Pain and spasticity impact on activities, mood and sleep - Adverse effects;Timepoint(s) of evaluation of this end point: baseline and 6 weeks treament | — |
Countries
Denmark
Contacts
Public ContactForskningsenheden
Spinal Cord Injury Centre of Western Denmark
Outcome results
None listed