Muscle Spasticity as a Result of Spinal Cord Injury
Conditions
Keywords
Spasticity, Spinal Cord Injury
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).
Interventions
DRUGnabilone 0.5 mg
nabilone 0.5 mg tablets od titrated to a maximum daily dose of 3mg po over an 11-week phase
DRUGplacebo
placebo 0.5 mg po daily, dose titrated to a maximum daily dose of 3.0mg po over an 11-week phase
Sponsors
The Manitoba Spinal Cord Injury Research Fund
Canadian Paraplegic Association
Health Sciences Centre Foundation, Manitoba
University of Manitoba
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ashworth Scale | 26 weeks | A scale that grades resistance to rapid passive movement across a relaxed joint on an ordinal scale of 0 to 4. |
| VAS (visual analog scale)pain intensity scale | 26 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale | 26 weeks | Patients rate the intensity of their spasms on a 100 mm pencil and paper VAS scale |
| Pittsburgh Sleep Quality Index | 26 weeks | Questionnaire that measures patient-reported sleep quality that will be administered at Visits 1,6 and 12 |
| Subject's Global Impression of Change | 26 weeks | Questionnaire that asks the subject to rate his or her impression of the effects of the study medication. |
| Sum of the Ashworth Scale in the eight muscle groups of each side of the body. | 26 weeks | As above |
| VAS Pain Impact Scale | 26 weeks | A continuous scale measuring the impact of pain with 0mm being non-disruptive and 100 mm being incapacitating |
| The Short Form McGill Pain Questionnaire (SF-MPQ) | 26 weeks | 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 |
| Neuropathic Pain Questionnaire | 26 weeks | A clinician-administered questionnaire consisting of both sensory descriptors and signs related to bedside sensory examination |
| Clinician's Global Impression of Change | 26 weeks | Questionnaire that asks the Clinician to rate his or her impression of the effect of study medication. |
| Penn Spasm Frequency Scale | 26 weeks | Scale graded by study participants to measure frequency of muscle spasms throughout the period in question |
Countries
Canada
Outcome results
None listed