Randomized Double Blind Cross Over Study for Nabilone in Spasticity in Spinal Cord Injury Persons - Full Text View

Sponsors and Collaborators:	University of Manitoba Valeant Canada
Information provided by:	University of Manitoba
ClinicalTrials.gov Identifier:	NCT00623376

Purpose

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 .

Condition	Intervention	Phase
Spasticity in Spinal Cord Injured Persons	Drug: nabilone then placebo Drug: placebo then nabilone	Phase II

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

Resource links provided by NLM:

MedlinePlus related topics: Spinal Cord Injuries

Drug Information available for: Nabilone

U.S. FDA Resources

Further study details as provided by University of Manitoba:

Primary Outcome Measures:

Ashworth scale in most involved group muscles [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]

Study Start Date:	July 2007
Study Completion Date:	December 2007
Primary Completion Date:	November 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator first on treatment then on Placebo	Drug: nabilone then placebo The subjects were first on Nabilone, then crossed over to placebo
2: Placebo Comparator first on placebo then on treatment	Drug: placebo then nabilone the subjects were first on placebo then crossed over to nabilone

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00623376

Locations

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

Sponsors and Collaborators

University of Manitoba

Valeant Canada

More Information

No publications provided

Responsible Party:	University of Manitoba ( Sepideh Pooyania )
Study ID Numbers:	4940
Study First Received:	February 14, 2008
Last Updated:	February 25, 2008
ClinicalTrials.gov Identifier:	NCT00623376 History of Changes
Health Authority:	Canada: Health Canada

Study placed in the following topic categories:

Tranquilizing Agents
Psychotropic Drugs
Antiemetics
Central Nervous System Depressants
Nabilone
Spinal Cord Injuries
Signs and Symptoms

Muscle Spasticity
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neurologic Manifestations
Anti-Anxiety Agents
Peripheral Nervous System Agents

Additional relevant MeSH terms:

Neuromuscular Manifestations
Tranquilizing Agents
Nervous System Diseases
Physiological Effects of Drugs
Psychotropic Drugs
Gastrointestinal Agents
Central Nervous System Depressants
Antiemetics
Nabilone
Pharmacologic Actions
Signs and Symptoms

Muscle Spasticity
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Autonomic Agents
Therapeutic Uses
Neurologic Manifestations
Anti-Anxiety Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 03, 2009