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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
12
nabilone 0.5 mg tablets od titrated to a maximum daily dose of 3mg po over an 11-week phase
placebo 0.5 mg po daily, dose titrated to a maximum daily dose of 3.0mg po over an 11-week phase
Health Sciences Centre Rehabilitation Hospital
Winnipeg, Manitoba, Canada
Ashworth Scale
A scale that grades resistance to rapid passive movement across a relaxed joint on an ordinal scale of 0 to 4.
Time frame: 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.
Time frame: 26 weeks
Sum of the Ashworth Scale in the eight muscle groups of each side of the body.
As above
Time frame: 26 weeks
Penn Spasm Frequency Scale
Scale graded by study participants to measure frequency of muscle spasms throughout the period in question
Time frame: 26 weeks
Visual Analog Scale
Patients rate the intensity of their spasms on a 100 mm pencil and paper VAS scale
Time frame: 26 weeks
Pittsburgh Sleep Quality Index
Questionnaire that measures patient-reported sleep quality that will be administered at Visits 1,6 and 12
Time frame: 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.
Time frame: 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.
Time frame: 26 weeks
VAS Pain Impact Scale
A continuous scale measuring the impact of pain with 0mm being non-disruptive and 100 mm being incapacitating
Time frame: 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
Time frame: 26 weeks
Neuropathic Pain Questionnaire
A clinician-administered questionnaire consisting of both sensory descriptors and signs related to bedside sensory examination
Time frame: 26 weeks
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