Trial | NCT01222468  Report issue

Title

Effect of Cannabinoids on Spasticity and Neuropathic Pain in Spinal Cord Injured Persons
A Randomized Double-Blinded Crossover Trial Assessing the Effect of Cannabinoids on Spasticity and Neuropathic Pain in Spinal Cord Injured Persons

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    nabilone ...

  • Study Participants

    12
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 Started
Jun 30
2012
Primary Completion
Feb 28
2015
Study Completion
Feb 28
2015
Last Update
Feb 25
2015
Estimate

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 names: Cesamet

Drug placebo

placebo 0.5 mg po daily, dose titrated to a maximum daily dose of 3.0mg po over an 11-week phase

nabilone Active Comparator

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

placebo Placebo Comparator

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

Criteria 

Inclusion Criteria:

Spinal Cord Injury
12 months post -injury
C2-T12, ASIA A-D, stable level of injury
moderate to severe spasticity or moderate to severe neuropathic pain
no cognitive impairment
spasticity medications unchanged for at least 30 days or inadequate pain control at a stabilized dose of either gabapentin or pregabalin for at least 30 days
no botulinum toxin injections x 6 months

Exclusion Criteria:

significant cardiovascular disease
major illness in another body area
history of psychological disorders or predisposition to psychosis
sensitivity to cannabinoids
severe liver disfunction
history of drug dependancy
fixed tendon contractures
used cannabis in the past 30 days
unwilling to refrain from smoking cannabis during the study
pregnant or nursing mother
No Results Posted