Effect of Cannabinoids on Spasticity and Neuropathic Pain in Spinal Cord Injured Persons

Study Overview
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Brief Summary
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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).

Official Title
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A Randomized Double-Blinded Crossover Trial Assessing the Effect of Cannabinoids on Spasticity and Neuropathic Pain in Spinal Cord Injured Persons

Conditions
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Muscle Spasticity as a Result of Spinal Cord Injury

Intervention / Treatment
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* Drug: nabilone 0.5 mg
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: nabilone<br>nabilone 0.5 mg tablets dose-titrated over an 11-week period to a maximum of 3mg po daily. Subjects are allowed to drop back to the previous dose following a dose increase once if required | Drug: nabilone 0.5 mg<br>* nabilone 0.5 mg tablets od titrated to a maximum daily dose of 3mg po over an 11-week phase<br>* Other names: Cesamet;|
| Placebo Comparator: placebo<br>look-alike 0.5 mg placebo tablets titrated to a maximum daily dose of 3.0 mg daily over an 11-week phase. Subjects are allowed to drop back to the previous dose following a dose increase once during the 11-week phase if required | Drug: placebo<br>* placebo 0.5 mg po daily, dose titrated to a maximum daily dose of 3.0mg po over an 11-week phase<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ashworth Scale | A scale that grades resistance to rapid passive movement across a relaxed joint on an ordinal scale of 0 to 4. | 26 weeks | 
| VAS (visual analog scale)pain intensity scale | Primary outcome measure for pain will be a change in the VAS pain intensity scale. Using a visual intensity scale, patients are asked to record their daily pain score over the previous 24 hours. | 26 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sum of the Ashworth Scale in the eight muscle groups of each side of the body. | As above | 26 weeks | 
| Penn Spasm Frequency Scale | Scale graded by study participants to measure frequency of muscle spasms throughout the period in question | 26 weeks | 
| Visual Analog Scale | Patients rate the intensity of their spasms on a 100 mm pencil and paper VAS scale | 26 weeks | 
| Pittsburgh Sleep Quality Index | Questionnaire that measures patient-reported sleep quality that will be administered at Visits 1,6 and 12 | 26 weeks | 
| Subject's Global Impression of Change | Questionnaire that asks the subject to rate his or her impression of the effects of the study medication. | 26 weeks | 
| Clinician's Global Impression of Change | Questionnaire that asks the Clinician to rate his or her impression of the effect of study medication. | 26 weeks | 
| VAS Pain Impact Scale | A continuous scale measuring the impact of pain with 0mm being non-disruptive and 100 mm being incapacitating | 26 weeks | 
| The Short Form McGill Pain Questionnaire (SF-MPQ) | A questionnaire with 3 components: a VAS to determine overall pain levels, a 15-word list of pain descriptors; and a Present Pain Intensity Scale to determine patient's pain at the time of survey completion | 26 weeks | 
| Neuropathic Pain Questionnaire | A clinician-administered questionnaire consisting of both sensory descriptors and signs related to bedside sensory examination | 26 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Spasticity, Spinal Cord Injury