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

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

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 .

Study Overview

• Status: Completed
• Conditions: Spasticity in Spinal Cord Injured Persons
• Intervention / Treatment: Drug: nabilone then placebo; Drug: placebo then nabilone

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3A 1M4
      • Rehabilitation hospital ,800 sherbrook St.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1; first on treatment then on Placebo	Drug: nabilone then placebo; The subjects were first on Nabilone, then crossed over to placebo
Placebo Comparator: 2; first on placebo then on treatment	Drug: placebo then nabilone; the subjects were first on placebo then crossed over to nabilone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Ashworth scale in most involved group muscles	10 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Manitoba
• Collaborators: Valeant Canada Limited

Study record dates

Study Major Dates

• Study Start: July 1, 2007
• Primary Completion (Actual): November 1, 2007
• Study Completion (Actual): December 1, 2007

Study Registration Dates

• First Submitted: February 14, 2008
• First Submitted That Met QC Criteria: February 25, 2008
• First Posted (Estimate): February 26, 2008

Study Record Updates

• Last Update Posted (Estimate): February 26, 2008
• Last Update Submitted That Met QC Criteria: February 25, 2008
• Last Verified: June 1, 2007

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Muscle Hypertonia; Muscle Spasticity; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Antiemetics; Gastrointestinal Agents; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Tranquilizing Agents; Psychotropic Drugs; Anti-Anxiety Agents; Hallucinogens; Cannabinoid Receptor Agonists; Cannabinoid Receptor Modulators; Dronabinol; Nabilone
• Other Study ID Numbers: 4940