search
Back to results

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

Primary Purpose

Spasticity in Spinal Cord Injured Persons

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
nabilone then placebo
placebo then nabilone
Sponsored by
University of Manitoba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional trial for Spasticity in Spinal Cord Injured Persons

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rehabilitation hospital ,800 sherbrook St.

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1

2

Arm Description

first on treatment then on Placebo

first on placebo then on treatment

Outcomes

Primary Outcome Measures

Ashworth scale in most involved group muscles

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 .

Full Information

First Posted
February 14, 2008
Last Updated
February 25, 2008
Sponsor
University of Manitoba
Collaborators
Valeant Canada Limited
search

1. Study Identification

Unique Protocol Identification Number
NCT00623376
Brief Title
Randomized Double Blind Cross Over Study for Nabilone in Spasticity in Spinal Cord Injury Persons
Official Title
Randomized Double Blind Cross Over Study Assessing the Effect of Cannabiniods on Spasticity in Spinal Cord Injured Persons :A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2007
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Manitoba
Collaborators
Valeant Canada Limited

4. Oversight

5. Study Description

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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spasticity in Spinal Cord Injured Persons

7. Study Design

Study Phase
Phase 2

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
first on treatment then on Placebo
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
first on placebo then on treatment
Intervention Type
Drug
Intervention Name(s)
nabilone then placebo
Intervention Description
The subjects were first on Nabilone, then crossed over to placebo
Intervention Type
Drug
Intervention Name(s)
placebo then nabilone
Intervention Description
the subjects were first on placebo then crossed over to nabilone
Primary Outcome Measure Information:
Title
Ashworth scale in most involved group muscles
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Rehabilitation hospital ,800 sherbrook St.
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3A 1M4
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs