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Randomized Double Blind Cross Over Study for Nabilone in Spasticity in Spinal Cord Injury Persons

NCT00623376 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2008-02-26

No results posted yet for this study

Summary

Objectives: To determine whether nabilone, a synthetic cannabinoid, alleviates spasticity in people with spinal cord injury (SCI).

Methods: Twelve subjects were enrolled in this double-blind, placebo-controlled, crossover study. They received either nabilone or placebo during the first four-week period (0.5mg OD with option to increase to 0.5mg BID), then outcome measures were assessed. After a two-week washout, subjects were crossed-over to the opposite arm.

The primary outcome was the Ashworth scale for spasticity in the most involved muscle group, chosen by the subject and clinician. The secondary outcomes included Spasm Frequency Scale, Visual Analog Scale, Wartenberg Pendulum Test, sum of the Ashworth Scale in eight muscle groups of each side of the body, and the Clinician's and Subject's Global Impression of Change .

Conditions

  • Spasticity in Spinal Cord Injured Persons

Interventions

DRUG

nabilone then placebo

The subjects were first on Nabilone, then crossed over to placebo

DRUG

placebo then nabilone

the subjects were first on placebo then crossed over to nabilone

Sponsors & Collaborators

  • Valeant Canada Limited

    collaborator INDUSTRY

  • University of Manitoba

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-07-31
Primary Completion
2007-11-30
Completion
2007-12-31

Countries

  • Canada

Study Locations

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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 NCT00623376 on ClinicalTrials.gov