NCT01222468

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: University of Manitoba · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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).

Conditions

• Muscle Spasticity as a Result of Spinal Cord Injury

Interventions

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

Timeline

• Start date: 2012-06-01
• Primary completion: 2015-02-01
• Completion: 2015-02-01
• First posted: 2010-10-18
• Last updated: 2015-02-25

Locations

1 site across 1 country: Canada