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

NCT00623376 | Completed Phase 2

• 1 other identifier: 4940
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Ashworth scale in most involved group muscles

  10 weeks

Secondary Outcomes (1)

• 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 .

  10 weeks

Study Arms (2)

1

ACTIVE COMPARATOR

first on treatment then on Placebo

Drug: nabilone then placebo

2

PLACEBO COMPARATOR

first on placebo then on treatment

Drug: placebo then nabilone

Interventions

nabilone then placebo DRUG

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

1

placebo then nabilone DRUG

the subjects were first on placebo then crossed over to nabilone

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• They were excluded if they had:
• Heart disease as cannabinoids can reduce heart rate and blood pressure
• History of psychotic disorders, schizophrenia or any active psychological disorder
• Previously documented sensitivity to marijuana or other cannabinoid agents
• Severe liver dysfunction
• Cognitive impairment
• Major illness in another body area
• If they were pregnant or nursing mother
• Had history of drug dependency
• Used smoked cannabis \< 30 days before the onset of the study or were unwilling not to smoke during the study; OR
• If they fixed tendon contractures

Sponsors & Collaborators

• University of Manitoba: lead
• Valeant Canada Limited: collaborator

Study Sites (1)

Rehabilitation hospital ,800 sherbrook St.

Winnipeg, Manitoba, R3A 1M4, Canada

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 14, 2008
• First Posted: February 26, 2008
• Study Start: July 1, 2007
• Primary Completion: November 1, 2007
• Study Completion: December 1, 2007
• Last Updated: February 26, 2008

Record last verified: 2007-06

Locations

CA (1)