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

Phase 2

Completed

• Conditions: Spasticity in Spinal Cord Injured Persons
• Interventions: Drug: nabilone then placebo; Drug: placebo then nabilone

• Registration Number: NCT00623376
• Lead Sponsor: University of Manitoba

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 .

Detailed Description

Not available

Study Timeline

• Status Verified: 2007-06
• Study Start: 2007-07
• Primary Completion: 2007-11
• Study Completion: 2007-12
• Study First Submitted: 2008-02-14
• Study First Submitted QC: 2008-02-25
• Last Update Submitted: 2008-02-25
• Study First Posted: 2008-02-26
• Last Update Posted: 2008-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	nabilone then placebo	first on treatment then on Placebo
2	placebo then nabilone	first on placebo then on treatment

Primary Outcome Measures

Name	Time	Method
Ashworth scale in most involved group muscles	10 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Rehabilitation hospital ,800 sherbrook St.; 🇨🇦 Winnipeg, Manitoba, Canada