A Phase 2 interventional study of nabilone then placebo and placebo then nabilone in Spasticity in Spinal Cord Injured Persons, sponsored by University of Manitoba. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2008-02-26.
Sponsored by University of Manitoba · Phase 2 and Interventional
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 .
704 studies on the registry are indexed under Muscle Spasticity; 149 are open to participants now.
Browse Muscle Spasticity studies →University of Manitoba is the lead sponsor of 542 studies on the registry; 87 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 5 (42%) have results posted.
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Exclusion Criteria:
They were excluded if they had:
first on treatment then on Placebo
Drug: nabilone then placebo
first on placebo then on treatment
Drug: placebo then nabilone
The subjects were first on Nabilone, then crossed over to placebo
the subjects were first on placebo then crossed over to nabilone
Ashworth scale in most involved group muscles
Time frame: 10 weeks
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 .
Time frame: 10 weeks
This study is completed, as verified in Jun 2007. You cannot join it, but the record below documents what was studied.
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University of Manitoba