Status:
COMPLETED
Randomized Double Blind Cross Over Study for Nabilone in Spasticity in Spinal Cord Injury Persons
Lead Sponsor:
University of Manitoba
Collaborating Sponsors:
Valeant Canada Limited
Conditions:
Spasticity in Spinal Cord Injured Persons
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Objectives: To determine whether nabilone, a synthetic cannabinoid, alleviates spasticity in people with spinal cord injury (SCI). Methods: Twelve subjects were enrolled in this double-blind, placebo...
Eligibility Criteria
Inclusion
- Patients with spinal cord injury were eligible for the study if they are 18-65 years old, have C5 (ASIA A-D) and below and the injury occurred greater than 1 year previously. They had to have stable neurological level of injury with moderate spasticity (Ashworth \>/= 3) and no cognitive impairments. The spasticity medications needed to be unchanged for at least 30 days before inclusion, and no botulinum toxin injections for \> 4 months.
Exclusion
- They were excluded if they had:
- Heart disease as cannabinoids can reduce heart rate and blood pressure
- History of psychotic disorders, schizophrenia or any active psychological disorder
- Previously documented sensitivity to marijuana or other cannabinoid agents
- Severe liver dysfunction
- Cognitive impairment
- Major illness in another body area
- If they were pregnant or nursing mother
- Had history of drug dependency
- Used smoked cannabis \< 30 days before the onset of the study or were unwilling not to smoke during the study; OR
- If they fixed tendon contractures
Key Trial Info
Start Date :
July 1 2007
Trial Type :
INTERVENTIONAL
End Date :
December 1 2007
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00623376
Start Date
July 1 2007
End Date
December 1 2007
Last Update
February 26 2008
Active Locations (1)
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1
Rehabilitation hospital ,800 sherbrook St.
Winnipeg, Manitoba, Canada, R3A 1M4