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

NCT01222468 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2015-02-25

No results posted yet for this study

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

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

Sponsors & Collaborators

  • The Manitoba Spinal Cord Injury Research Fund

    collaborator UNKNOWN

  • Canadian Paraplegic Association

    collaborator OTHER

  • Health Sciences Centre Foundation, Manitoba

    collaborator OTHER

  • University of Manitoba

    lead OTHER

Principal Investigators

  • Karen D. Ethans, MD · University of Manitoba

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2015-02-28
Completion
2015-02-28

Countries

  • Canada

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01222468 on ClinicalTrials.gov