Muscle Spasticity as a Result of Spinal Cord Injury Clinical Trial
Official title:
A Randomized Double-Blinded Crossover Trial Assessing the Effect of Cannabinoids on Spasticity and Neuropathic Pain in Spinal Cord Injured Persons
| Verified date | February 2015 |
| Source | University of Manitoba |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Canada: Health Canada |
| Study type | Interventional |
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).
| Status | Completed |
| Enrollment | 12 |
| Est. completion date | February 2015 |
| Est. primary completion date | February 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 65 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Canada | Health Sciences Centre Rehabilitation Hospital | Winnipeg | Manitoba |
| Lead Sponsor | Collaborator |
|---|---|
| University of Manitoba | Canadian Paraplegic Association, Health Sciences Centre Foundation, Manitoba, The Manitoba Spinal Cord Injury Research Fund |
Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No |
| Primary | 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 | No |
| Secondary | Sum of the Ashworth Scale in the eight muscle groups of each side of the body. | As above | 26 weeks | No |
| Secondary | Penn Spasm Frequency Scale | Scale graded by study participants to measure frequency of muscle spasms throughout the period in question | 26 weeks | No |
| Secondary | Visual Analog Scale | Patients rate the intensity of their spasms on a 100 mm pencil and paper VAS scale | 26 weeks | No |
| Secondary | Pittsburgh Sleep Quality Index | Questionnaire that measures patient-reported sleep quality that will be administered at Visits 1,6 and 12 | 26 weeks | No |
| Secondary | 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 | No |
| Secondary | 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 | No |
| Secondary | VAS Pain Impact Scale | A continuous scale measuring the impact of pain with 0mm being non-disruptive and 100 mm being incapacitating | 26 weeks | No |
| Secondary | 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 | No |
| Secondary | Neuropathic Pain Questionnaire | A clinician-administered questionnaire consisting of both sensory descriptors and signs related to bedside sensory examination | 26 weeks | No |