Effect of Cannabinoids on Spasticity and Neuropathic Pain in Spinal Cord Injured Persons
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|ClinicalTrials.gov Identifier: NCT01222468|
Recruitment Status : Completed
First Posted : October 18, 2010
Last Update Posted : February 25, 2015
|Condition or disease||Intervention/treatment||Phase|
|Muscle Spasticity as a Result of Spinal Cord Injury||Drug: nabilone 0.5 mg Drug: placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized Double-Blinded Crossover Trial Assessing the Effect of Cannabinoids on Spasticity and Neuropathic Pain in Spinal Cord Injured Persons|
|Study Start Date :||June 2012|
|Actual Primary Completion Date :||February 2015|
|Actual Study Completion Date :||February 2015|
Active Comparator: nabilone
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
Drug: nabilone 0.5 mg
nabilone 0.5 mg tablets od titrated to a maximum daily dose of 3mg po over an 11-week phase
Other Name: Cesamet
Placebo Comparator: placebo
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
placebo 0.5 mg po daily, dose titrated to a maximum daily dose of 3.0mg po over an 11-week phase
- Ashworth Scale [ Time Frame: 26 weeks ]A scale that grades resistance to rapid passive movement across a relaxed joint on an ordinal scale of 0 to 4.
- VAS (visual analog scale)pain intensity scale [ Time Frame: 26 weeks ]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.
- Sum of the Ashworth Scale in the eight muscle groups of each side of the body. [ Time Frame: 26 weeks ]As above
- Penn Spasm Frequency Scale [ Time Frame: 26 weeks ]Scale graded by study participants to measure frequency of muscle spasms throughout the period in question
- Visual Analog Scale [ Time Frame: 26 weeks ]Patients rate the intensity of their spasms on a 100 mm pencil and paper VAS scale
- Pittsburgh Sleep Quality Index [ Time Frame: 26 weeks ]Questionnaire that measures patient-reported sleep quality that will be administered at Visits 1,6 and 12
- Subject's Global Impression of Change [ Time Frame: 26 weeks ]Questionnaire that asks the subject to rate his or her impression of the effects of the study medication.
- Clinician's Global Impression of Change [ Time Frame: 26 weeks ]Questionnaire that asks the Clinician to rate his or her impression of the effect of study medication.
- VAS Pain Impact Scale [ Time Frame: 26 weeks ]A continuous scale measuring the impact of pain with 0mm being non-disruptive and 100 mm being incapacitating
- The Short Form McGill Pain Questionnaire (SF-MPQ) [ Time Frame: 26 weeks ]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
- Neuropathic Pain Questionnaire [ Time Frame: 26 weeks ]A clinician-administered questionnaire consisting of both sensory descriptors and signs related to bedside sensory examination
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): NCT01222468
|Health Sciences Centre Rehabilitation Hospital|
|Winnipeg, Manitoba, Canada, R3A 1M4|
|Principal Investigator:||Karen D. Ethans, MD||University of Manitoba|