Clinical trial NCT01222468: Effect of Cannabinoids on Spasticity and Neuropathic Pain in Spinal Cord Injured Persons
Official title: A Randomized Double-Blinded Crossover Trial Assessing the Effect of Cannabinoids on Spasticity and Neuropathic Pain in Spinal Cord Injured Persons
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Muscle Spasticity as a Result of Spinal Cord Injury
Keywords: Spasticity, Spinal Cord Injury
Lead sponsor: University of Manitoba
Sponsor class: OTHER
Collaborators: name: The Manitoba Spinal Cord Injury Research Fund
name: Canadian Paraplegic Association
name: Health Sciences Centre Foundation, Manitoba
First posted: 2010-10-18
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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 crossover study. Each eligible subject will participate for 26 weeks.Subjects will be randomized to receive either nabilone or placebo during phase 1 of the study. Study drug will be titrated up from 0.5mg daily to a maximum of 3.0 mg daily over the first 11-week phase. Following a 4-week washout period, subjects will be crossed-over to the opposite arm for another 11 week treatment period (phase 2).


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Ashworth Scale
timeFrame: 26 weeks
measure: VAS (visual analog scale)pain intensity scale
timeFrame: 26 weeks
Secondary outcomes:
measure: Sum of the Ashworth Scale in the eight muscle groups of each side of the body.
timeFrame: 26 weeks
measure: Penn Spasm Frequency Scale
timeFrame: 26 weeks
measure: Visual Analog Scale
timeFrame: 26 weeks
measure: Pittsburgh Sleep Quality Index
timeFrame: 26 weeks
measure: Subject's Global Impression of Change
timeFrame: 26 weeks
measure: Clinician's Global Impression of Change
timeFrame: 26 weeks
measure: VAS Pain Impact Scale
timeFrame: 26 weeks
measure: The Short Form McGill Pain Questionnaire (SF-MPQ)
timeFrame: 26 weeks
measure: Neuropathic Pain Questionnaire
timeFrame: 26 weeks
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Health Sciences Centre Rehabilitation Hospital
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Karen D. Ethans, MD
role: PRINCIPAL_INVESTIGATOR
References: