Completed

NCT Number: NCT00623376

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

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 .

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Key information

Conditions

Spasticity in Spinal Cord Injured Persons

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Rehabilitation hospital ,800 sherbrook St.

Winnipeg, Manitoba, R3A 1M4, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

nabilone then placebo

Drug

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

placebo then nabilone

Drug

the subjects were first on placebo then crossed over to nabilone

Primary outcomes

Ashworth scale in most involved group muscles

Time frame: 10 weeks

Secondary outcomes

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 .

Time frame: 10 weeks

Sponsors and collaborators

Lead sponsor

University of Manitoba

Other

Collaborators

Valeant Canada Limited

Registry information

Official study title

Randomized Double Blind Cross Over Study Assessing the Effect of Cannabiniods on Spasticity in Spinal Cord Injured Persons :A Pilot Study

Important dates

Study start: 2007
Primary completion: 2007
Study completion: 2007
First posted: Feb 26, 2008
Registry last updated: Feb 26, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.