Randomized Double Blind Cross Over Study for Nabilone in Spasticity in Spinal Cord Injury Persons
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|ClinicalTrials.gov Identifier: NCT00623376|
Recruitment Status : Completed
First Posted : February 26, 2008
Last Update Posted : February 26, 2008
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 or disease||Intervention/treatment||Phase|
|Spasticity in Spinal Cord Injured Persons||Drug: nabilone then placebo Drug: placebo then nabilone||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|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|
|Actual Primary Completion Date :||November 2007|
|Actual Study Completion Date :||December 2007|
Active Comparator: 1
first on treatment then on Placebo
Drug: nabilone then placebo
The subjects were first on Nabilone, then crossed over to placebo
Placebo Comparator: 2
first on placebo then on treatment
Drug: placebo then nabilone
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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00623376
|Rehabilitation hospital ,800 sherbrook St.|
|Winnipeg, Manitoba, Canada, R3A 1M4|