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| Name | Class |
|---|---|
| The Manitoba Spinal Cord Injury Research Fund | UNKNOWN |
| Canadian Paraplegic Association | OTHER |
| Health Sciences Centre Foundation, Manitoba | OTHER |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| nabilone | Active Comparator | 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 |
|
| placebo | Placebo Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nabilone 0.5 mg | Drug | nabilone 0.5 mg tablets od titrated to a maximum daily dose of 3mg po over an 11-week phase |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karen D. Ethans, MD | University of Manitoba | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Health Sciences Centre Rehabilitation Hospital | Winnipeg | Manitoba | R3A 1M4 | Canada |
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| ID | Term |
|---|---|
| D009128 | Muscle Spasticity |
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009122 | Muscle Hypertonia |
| D020879 | Neuromuscular Manifestations |
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| ID | Term |
|---|---|
| C011941 | nabilone |
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| placebo | Drug | placebo 0.5 mg po daily, dose titrated to a maximum daily dose of 3.0mg po over an 11-week phase |
|
| 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 |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |