Status:
COMPLETED
Effect of Cannabinoids on Spasticity and Neuropathic Pain in Spinal Cord Injured Persons
Lead Sponsor:
University of Manitoba
Collaborating Sponsors:
The Manitoba Spinal Cord Injury Research Fund
Canadian Paraplegic Association
Conditions:
Muscle Spasticity as a Result of Spinal Cord Injury
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
This study is being conducted to study the effect of nabilone (a synthetic cannabinoid)on spasticity in spinal cord injured persons.The study will be a phase 2, randomized, placebo-controlled crossove...
Eligibility Criteria
Inclusion
- Spinal Cord Injury
- 12 months post -injury
- C2-T12, ASIA A-D, stable level of injury
- moderate to severe spasticity or moderate to severe neuropathic pain
- no cognitive impairment
- spasticity medications unchanged for at least 30 days or inadequate pain control at a stabilized dose of either gabapentin or pregabalin for at least 30 days
- no botulinum toxin injections x 6 months
Exclusion
- significant cardiovascular disease
- major illness in another body area
- history of psychological disorders or predisposition to psychosis
- sensitivity to cannabinoids
- severe liver disfunction
- history of drug dependancy
- fixed tendon contractures
- used cannabis in the past 30 days
- unwilling to refrain from smoking cannabis during the study
- pregnant or nursing mother
Key Trial Info
Start Date :
June 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2015
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01222468
Start Date
June 1 2012
End Date
February 1 2015
Last Update
February 25 2015
Active Locations (1)
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1
Health Sciences Centre Rehabilitation Hospital
Winnipeg, Manitoba, Canada, R3A 1M4