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

This study has been completed.
Sponsor:
Collaborator:
Valeant Canada Limited
Information provided by:
University of Manitoba
ClinicalTrials.gov Identifier:
NCT00623376
First received: February 14, 2008
Last updated: February 25, 2008
Last verified: June 2007
  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 2

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:


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
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

  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 Limited
  More Information

No publications provided

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

Additional relevant MeSH terms:
Muscle Spasticity
Spinal Cord Injuries
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Spinal Cord Diseases
Central Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Nabilone
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs

ClinicalTrials.gov processed this record on April 23, 2014