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Sponsors and Collaborators: |
University of Manitoba Valeant Canada |
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Information provided by: | University of Manitoba |
ClinicalTrials.gov Identifier: | NCT00623376 |
Objectives: To determine whether nabilone, a synthetic cannabinoid, alleviates spasticity in people with spinal cord injury (SCI).
Methods: Twelve subjects were enrolled in this double-blind, placebo-controlled, crossover study. They received either nabilone or placebo during the first four-week period (0.5mg OD with option to increase to 0.5mg BID), then outcome measures were assessed. After a two-week washout, subjects were crossed-over to the opposite arm.
The primary outcome was the Ashworth scale for spasticity in the most involved muscle group, chosen by the subject and clinician. The secondary outcomes included Spasm Frequency Scale, Visual Analog Scale, Wartenberg Pendulum Test, sum of the Ashworth Scale in eight muscle groups of each side of the body, and the Clinician's and Subject's Global Impression of Change .
Condition | Intervention | Phase |
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Spasticity in Spinal Cord Injured Persons |
Drug: nabilone then placebo Drug: placebo then nabilone |
Phase II |
Study Type: | Interventional |
Official Title: | Randomized Double Blind Cross Over Study Assessing the Effect of Cannabiniods on Spasticity in Spinal Cord Injured Persons :A Pilot Study |
Study Start Date: | July 2007 |
Study Completion Date: | December 2007 |
Primary Completion Date: | November 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
first on treatment then on Placebo
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Drug: nabilone then placebo
The subjects were first on Nabilone, then crossed over to placebo
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2: Placebo Comparator
first on placebo then on treatment
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Drug: placebo then nabilone
the subjects were first on placebo then crossed over to nabilone
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
They were excluded if they had:
Responsible Party: | University of Manitoba ( Sepideh Pooyania ) |
Study ID Numbers: | 4940 |
Study First Received: | February 14, 2008 |
Last Updated: | February 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00623376 |
Health Authority: | Canada: Health Canada |
Signs and Symptoms Spinal Cord Injuries Muscle Spasticity Muscular Diseases |
Musculoskeletal Diseases Muscle Hypertonia Neurologic Manifestations Nabilone |
Neuromuscular Manifestations Tranquilizing Agents Nervous System Diseases Physiological Effects of Drugs Psychotropic Drugs Gastrointestinal Agents Antiemetics |
Central Nervous System Depressants Pharmacologic Actions Autonomic Agents Therapeutic Uses Anti-Anxiety Agents Peripheral Nervous System Agents Central Nervous System Agents |