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

NCT ID: NCT00623376

Last Updated: 2008-02-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-07-31
• Study Completion Date: 2007-12-31

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

Study Groups

1

first on treatment then on Placebo

Group Type: ACTIVE_COMPARATOR

nabilone then placebo

Intervention Type: DRUG

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

2

first on placebo then on treatment

Group Type: PLACEBO_COMPARATOR

placebo then nabilone

Intervention Type: DRUG

the subjects were first on placebo then crossed over to nabilone

Interventions

nabilone then placebo

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

Intervention Type: DRUG

placebo then nabilone

the subjects were first on placebo then crossed over to nabilone

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients with spinal cord injury were eligible for the study if they are 18-65 years old, have C5 (ASIA A-D) and below and the injury occurred greater than 1 year previously. They had to have stable neurological level of injury with moderate spasticity (Ashworth >/= 3) and no cognitive impairments. The spasticity medications needed to be unchanged for at least 30 days before inclusion, and no botulinum toxin injections for > 4 months.

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Valeant Canada Limited

INDUSTRY

Sponsor Role: collaborator

University of Manitoba

OTHER

Sponsor Role: lead

Responsible Party

University of Manitoba

Locations

Rehabilitation hospital ,800 sherbrook St.

Winnipeg, Manitoba, Canada

Countries

Canada

Other Identifiers

4940

Identifier Type: -

Identifier Source: org_study_id