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Effect of Cannabinoids on Spasticity and Neuropathic Pain in Spinal Cord Injured Persons

Primary Purpose

Muscle Spasticity as a Result of Spinal Cord Injury

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
nabilone 0.5 mg
placebo
Sponsored by
University of Manitoba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Muscle Spasticity as a Result of Spinal Cord Injury focused on measuring Spasticity, Spinal Cord Injury

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Spinal Cord Injury
  • 12 months post -injury
  • C2-T12, ASIA A-D, stable level of injury
  • moderate to severe spasticity or moderate to severe neuropathic pain
  • no cognitive impairment
  • spasticity medications unchanged for at least 30 days or inadequate pain control at a stabilized dose of either gabapentin or pregabalin for at least 30 days
  • no botulinum toxin injections x 6 months

Exclusion Criteria:

  • significant cardiovascular disease
  • major illness in another body area
  • history of psychological disorders or predisposition to psychosis
  • sensitivity to cannabinoids
  • severe liver disfunction
  • history of drug dependancy
  • fixed tendon contractures
  • used cannabis in the past 30 days
  • unwilling to refrain from smoking cannabis during the study
  • pregnant or nursing mother

Sites / Locations

  • Health Sciences Centre Rehabilitation Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

nabilone

placebo

Arm Description

nabilone 0.5 mg tablets dose-titrated over an 11-week period to a maximum of 3mg po daily. Subjects are allowed to drop back to the previous dose following a dose increase once if required

look-alike 0.5 mg placebo tablets titrated to a maximum daily dose of 3.0 mg daily over an 11-week phase. Subjects are allowed to drop back to the previous dose following a dose increase once during the 11-week phase if required

Outcomes

Primary Outcome Measures

Ashworth Scale
A scale that grades resistance to rapid passive movement across a relaxed joint on an ordinal scale of 0 to 4.
VAS (visual analog scale)pain intensity scale
Primary outcome measure for pain will be a change in the VAS pain intensity scale. Using a visual intensity scale, patients are asked to record their daily pain score over the previous 24 hours.

Secondary Outcome Measures

Sum of the Ashworth Scale in the eight muscle groups of each side of the body.
As above
Penn Spasm Frequency Scale
Scale graded by study participants to measure frequency of muscle spasms throughout the period in question
Visual Analog Scale
Patients rate the intensity of their spasms on a 100 mm pencil and paper VAS scale
Pittsburgh Sleep Quality Index
Questionnaire that measures patient-reported sleep quality that will be administered at Visits 1,6 and 12
Subject's Global Impression of Change
Questionnaire that asks the subject to rate his or her impression of the effects of the study medication.
Clinician's Global Impression of Change
Questionnaire that asks the Clinician to rate his or her impression of the effect of study medication.
VAS Pain Impact Scale
A continuous scale measuring the impact of pain with 0mm being non-disruptive and 100 mm being incapacitating
The Short Form McGill Pain Questionnaire (SF-MPQ)
A questionnaire with 3 components: a VAS to determine overall pain levels, a 15-word list of pain descriptors; and a Present Pain Intensity Scale to determine patient's pain at the time of survey completion
Neuropathic Pain Questionnaire
A clinician-administered questionnaire consisting of both sensory descriptors and signs related to bedside sensory examination

Full Information

First Posted
October 14, 2010
Last Updated
February 24, 2015
Sponsor
University of Manitoba
Collaborators
The Manitoba Spinal Cord Injury Research Fund, Canadian Paraplegic Association, Health Sciences Centre Foundation, Manitoba
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1. Study Identification

Unique Protocol Identification Number
NCT01222468
Brief Title
Effect of Cannabinoids on Spasticity and Neuropathic Pain in Spinal Cord Injured Persons
Official Title
A Randomized Double-Blinded Crossover Trial Assessing the Effect of Cannabinoids on Spasticity and Neuropathic Pain in Spinal Cord Injured Persons
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Manitoba
Collaborators
The Manitoba Spinal Cord Injury Research Fund, Canadian Paraplegic Association, Health Sciences Centre Foundation, Manitoba

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is being conducted to study the effect of nabilone (a synthetic cannabinoid)on spasticity in spinal cord injured persons.The study will be a phase 2, randomized, placebo-controlled crossover study. Each eligible subject will participate for 26 weeks.Subjects will be randomized to receive either nabilone or placebo during phase 1 of the study. Study drug will be titrated up from 0.5mg daily to a maximum of 3.0 mg daily over the first 11-week phase. Following a 4-week washout period, subjects will be crossed-over to the opposite arm for another 11 week treatment period (phase 2).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Spasticity as a Result of Spinal Cord Injury
Keywords
Spasticity, Spinal Cord Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
nabilone
Arm Type
Active Comparator
Arm Description
nabilone 0.5 mg tablets dose-titrated over an 11-week period to a maximum of 3mg po daily. Subjects are allowed to drop back to the previous dose following a dose increase once if required
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
look-alike 0.5 mg placebo tablets titrated to a maximum daily dose of 3.0 mg daily over an 11-week phase. Subjects are allowed to drop back to the previous dose following a dose increase once during the 11-week phase if required
Intervention Type
Drug
Intervention Name(s)
nabilone 0.5 mg
Other Intervention Name(s)
Cesamet
Intervention Description
nabilone 0.5 mg tablets od titrated to a maximum daily dose of 3mg po over an 11-week phase
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo 0.5 mg po daily, dose titrated to a maximum daily dose of 3.0mg po over an 11-week phase
Primary Outcome Measure Information:
Title
Ashworth Scale
Description
A scale that grades resistance to rapid passive movement across a relaxed joint on an ordinal scale of 0 to 4.
Time Frame
26 weeks
Title
VAS (visual analog scale)pain intensity scale
Description
Primary outcome measure for pain will be a change in the VAS pain intensity scale. Using a visual intensity scale, patients are asked to record their daily pain score over the previous 24 hours.
Time Frame
26 weeks
Secondary Outcome Measure Information:
Title
Sum of the Ashworth Scale in the eight muscle groups of each side of the body.
Description
As above
Time Frame
26 weeks
Title
Penn Spasm Frequency Scale
Description
Scale graded by study participants to measure frequency of muscle spasms throughout the period in question
Time Frame
26 weeks
Title
Visual Analog Scale
Description
Patients rate the intensity of their spasms on a 100 mm pencil and paper VAS scale
Time Frame
26 weeks
Title
Pittsburgh Sleep Quality Index
Description
Questionnaire that measures patient-reported sleep quality that will be administered at Visits 1,6 and 12
Time Frame
26 weeks
Title
Subject's Global Impression of Change
Description
Questionnaire that asks the subject to rate his or her impression of the effects of the study medication.
Time Frame
26 weeks
Title
Clinician's Global Impression of Change
Description
Questionnaire that asks the Clinician to rate his or her impression of the effect of study medication.
Time Frame
26 weeks
Title
VAS Pain Impact Scale
Description
A continuous scale measuring the impact of pain with 0mm being non-disruptive and 100 mm being incapacitating
Time Frame
26 weeks
Title
The Short Form McGill Pain Questionnaire (SF-MPQ)
Description
A questionnaire with 3 components: a VAS to determine overall pain levels, a 15-word list of pain descriptors; and a Present Pain Intensity Scale to determine patient's pain at the time of survey completion
Time Frame
26 weeks
Title
Neuropathic Pain Questionnaire
Description
A clinician-administered questionnaire consisting of both sensory descriptors and signs related to bedside sensory examination
Time Frame
26 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Spinal Cord Injury 12 months post -injury C2-T12, ASIA A-D, stable level of injury moderate to severe spasticity or moderate to severe neuropathic pain no cognitive impairment spasticity medications unchanged for at least 30 days or inadequate pain control at a stabilized dose of either gabapentin or pregabalin for at least 30 days no botulinum toxin injections x 6 months Exclusion Criteria: significant cardiovascular disease major illness in another body area history of psychological disorders or predisposition to psychosis sensitivity to cannabinoids severe liver disfunction history of drug dependancy fixed tendon contractures used cannabis in the past 30 days unwilling to refrain from smoking cannabis during the study pregnant or nursing mother
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen D. Ethans, MD
Organizational Affiliation
University of Manitoba
Official's Role
Principal Investigator
Facility Information:
Facility Name
Health Sciences Centre Rehabilitation Hospital
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3A 1M4
Country
Canada

12. IPD Sharing Statement

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Effect of Cannabinoids on Spasticity and Neuropathic Pain in Spinal Cord Injured Persons

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