nabilone 0.5 mg
nabilone 0.5 mg tablets od titrated to a maximum daily dose of 3mg po over an 11-week phase
CesametLoading study record…
Loading study record…
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).
Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2015-02-25
What this record can show
This locally preserved record separates the registered protocol from source-reported registry results. Neither is a treatment recommendation.
Registry facts
Linked local records
Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.
Interventions
nabilone 0.5 mg tablets od titrated to a maximum daily dose of 3mg po over an 11-week phase
Cesametplacebo 0.5 mg po daily, dose titrated to a maximum daily dose of 3.0mg po over an 11-week phase
Eligibility
primary outcomes
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.
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.
secondary outcomes
Time frame: 26 weeks
As above
Time frame: 26 weeks
Scale graded by study participants to measure frequency of muscle spasms throughout the period in question
Time frame: 26 weeks
Patients rate the intensity of their spasms on a 100 mm pencil and paper VAS scale
Time frame: 26 weeks
Questionnaire that measures patient-reported sleep quality that will be administered at Visits 1,6 and 12
Time frame: 26 weeks
Questionnaire that asks the subject to rate his or her impression of the effects of the study medication.
Time frame: 26 weeks
Questionnaire that asks the Clinician to rate his or her impression of the effect of study medication.
Time frame: 26 weeks
A continuous scale measuring the impact of pain with 0mm being non-disruptive and 100 mm being incapacitating
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
Time frame: 26 weeks
A clinician-administered questionnaire consisting of both sensory descriptors and signs related to bedside sensory examination
Publications
No exact PMID-linked public article is currently readable locally.