drugset / Trial / NCT01222468

Effect of Cannabinoids on Spasticity and Neuropathic Pain in Spinal Cord Injured Persons

NCT01222468

RandomizedCrossoverQuadruple-blindTreatment

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).

Timeline

Start
2012-06
Primary completion
2015-02
Completion
2015-02

Drugs

EvaluationDrugModalityDoseRoute
Comparator Nabilone Other / unclassified 3 mg Oral

Indications

No indication recorded.