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

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ClinicalTrials.gov Identifier: NCT01222468
Recruitment Status : Completed
First Posted : October 18, 2010
Last Update Posted : February 25, 2015
Information provided by (Responsible Party):

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).

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : June 2012
Primary Completion Date : February 2015
Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Nabilone
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :
  1. Ashworth Scale [ Time Frame: 26 weeks ]
    A scale that grades resistance to rapid passive movement across a relaxed joint on an ordinal scale of 0 to 4.

  2. VAS (visual analog scale)pain intensity scale [ Time Frame: 26 weeks ]
    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 :
  1. Sum of the Ashworth Scale in the eight muscle groups of each side of the body. [ Time Frame: 26 weeks ]
    As above

  2. Penn Spasm Frequency Scale [ Time Frame: 26 weeks ]
    Scale graded by study participants to measure frequency of muscle spasms throughout the period in question

  3. Visual Analog Scale [ Time Frame: 26 weeks ]
    Patients rate the intensity of their spasms on a 100 mm pencil and paper VAS scale

  4. Pittsburgh Sleep Quality Index [ Time Frame: 26 weeks ]
    Questionnaire that measures patient-reported sleep quality that will be administered at Visits 1,6 and 12

  5. Subject's Global Impression of Change [ Time Frame: 26 weeks ]
    Questionnaire that asks the subject to rate his or her impression of the effects of the study medication.

  6. Clinician's Global Impression of Change [ Time Frame: 26 weeks ]
    Questionnaire that asks the Clinician to rate his or her impression of the effect of study medication.

  7. VAS Pain Impact Scale [ Time Frame: 26 weeks ]
    A continuous scale measuring the impact of pain with 0mm being non-disruptive and 100 mm being incapacitating

  8. The Short Form McGill Pain Questionnaire (SF-MPQ) [ Time Frame: 26 weeks ]
    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

  9. Neuropathic Pain Questionnaire [ Time Frame: 26 weeks ]
    A clinician-administered questionnaire consisting of both sensory descriptors and signs related to bedside sensory examination

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01222468

Canada, Manitoba
Health Sciences Centre Rehabilitation Hospital
Winnipeg, Manitoba, Canada, R3A 1M4
Sponsors and Collaborators
University of Manitoba
The Manitoba Spinal Cord Injury Research Fund
Canadian Paraplegic Association
Health Sciences Centre Foundation, Manitoba
Principal Investigator: Karen D. Ethans, MD University of Manitoba
More Information

Responsible Party: Dr. Karen Ethans, Principal Investigator MD, University of Manitoba
ClinicalTrials.gov Identifier: NCT01222468     History of Changes
Other Study ID Numbers: 1976
First Posted: October 18, 2010    Key Record Dates
Last Update Posted: February 25, 2015
Last Verified: February 2015

Keywords provided by Dr. Karen Ethans, University of Manitoba:
Spasticity, Spinal Cord Injury

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