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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by University of Manitoba
Sponsor:
Collaborators:
The Manitoba Spinal Cord Injury Research Fund
Canadian Paraplegic Association
Health Sciences Centre Foundation, Manitoba
Information provided by (Responsible Party):
Dr. Karen Ethans, University of Manitoba
ClinicalTrials.gov Identifier:
NCT01222468
First received: October 14, 2010
Last updated: October 8, 2014
Last verified: October 2014
  Purpose

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).


Condition Intervention Phase
Muscle Spasticity as a Result of Spinal Cord Injury
Drug: nabilone 0.5 mg
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Double-Blinded Crossover Trial Assessing the Effect of Cannabinoids on Spasticity and Neuropathic Pain in Spinal Cord Injured Persons

Resource links provided by NLM:


Further study details as provided by University of Manitoba:

Primary Outcome Measures:
  • Ashworth Scale [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    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. [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    As above

  • Penn Spasm Frequency Scale [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    Scale graded by study participants to measure frequency of muscle spasms throughout the period in question

  • Visual Analog Scale [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    Patients rate the intensity of their spasms on a 100 mm pencil and paper VAS scale

  • Pittsburgh Sleep Quality Index [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    Questionnaire that measures patient-reported sleep quality that will be administered at Visits 1,6 and 12

  • Subject's Global Impression of Change [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    Questionnaire that asks the subject to rate his or her impression of the effects of the study medication.

  • Clinician's Global Impression of Change [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    Questionnaire that asks the Clinician to rate his or her impression of the effect of study medication.

  • VAS Pain Impact Scale [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    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) [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    A clinician-administered questionnaire consisting of both sensory descriptors and signs related to bedside sensory examination


Estimated Enrollment: 40
Study Start Date: June 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: nabilone
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
Drug: nabilone 0.5 mg
nabilone 0.5 mg tablets od titrated to a maximum daily dose of 3mg po over an 11-week phase
Other Name: Cesamet
Placebo Comparator: placebo
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
Drug: placebo
placebo 0.5 mg po daily, dose titrated to a maximum daily dose of 3.0mg po over an 11-week phase

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01222468

Contacts
Contact: Tracey Olafson, RN (204) 787-2725 tolafson@hsc.mb.ca

Locations
Canada, Manitoba
Health Sciences Centre Rehabilitation Hospital Recruiting
Winnipeg, Manitoba, Canada, R3A 1M4
Contact: Tracey Olafson, RN    (204) 787-2725    tolafson@hsc.mb.ca   
Principal Investigator: Karen D. Ethans, MD         
Sub-Investigator: Alan R. Casey, MD         
Sponsors and Collaborators
University of Manitoba
The Manitoba Spinal Cord Injury Research Fund
Canadian Paraplegic Association
Health Sciences Centre Foundation, Manitoba
Investigators
Principal Investigator: Karen D. Ethans, MD University of Manitoba
  More Information

No publications provided

Responsible Party: Dr. Karen Ethans, Principal Investigator MD, University of Manitoba
ClinicalTrials.gov Identifier: NCT01222468     History of Changes
Other Study ID Numbers: 1976
Study First Received: October 14, 2010
Last Updated: October 8, 2014
Health Authority: Canada: Health Canada

Keywords provided by University of Manitoba:
Spasticity, Spinal Cord Injury

Additional relevant MeSH terms:
Muscle Spasticity
Spinal Cord Injuries
Neuralgia
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Pain
Neurologic Manifestations
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
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 October 16, 2014