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

A Randomized Double-Blinded Crossover Trial Assessing the Effect of Cannabinoids on Spasticity and Neuropathic Pain in Spinal Cord Injured Persons

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).

Study Overview

• Status: Completed
• Conditions: Muscle Spasticity as a Result of Spinal Cord Injury
• Intervention / Treatment: Drug: nabilone 0.5 mg; Drug: placebo

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3A 1M4
      • Health Sciences Centre Rehabilitation Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ashworth Scale	A scale that grades resistance to rapid passive movement across a relaxed joint on an ordinal scale of 0 to 4.	26 weeks
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.	26 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sum of the Ashworth Scale in the eight muscle groups of each side of the body.	As above	26 weeks
Penn Spasm Frequency Scale	Scale graded by study participants to measure frequency of muscle spasms throughout the period in question	26 weeks
Visual Analog Scale	Patients rate the intensity of their spasms on a 100 mm pencil and paper VAS scale	26 weeks
Pittsburgh Sleep Quality Index	Questionnaire that measures patient-reported sleep quality that will be administered at Visits 1,6 and 12	26 weeks
Subject's Global Impression of Change	Questionnaire that asks the subject to rate his or her impression of the effects of the study medication.	26 weeks
Clinician's Global Impression of Change	Questionnaire that asks the Clinician to rate his or her impression of the effect of study medication.	26 weeks
VAS Pain Impact Scale	A continuous scale measuring the impact of pain with 0mm being non-disruptive and 100 mm being incapacitating	26 weeks
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	26 weeks
Neuropathic Pain Questionnaire	A clinician-administered questionnaire consisting of both sensory descriptors and signs related to bedside sensory examination	26 weeks

Collaborators and Investigators

• Sponsor: University of Manitoba
• Collaborators: Health Sciences Centre Foundation, Manitoba; Canadian Paraplegic Association; The Manitoba Spinal Cord Injury Research Fund
• Investigators: Principal Investigator: Karen D. Ethans, MD, University of Manitoba

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): February 1, 2015
• Study Completion (Actual): February 1, 2015

Study Registration Dates

• First Submitted: October 14, 2010
• First Submitted That Met QC Criteria: October 15, 2010
• First Posted (Estimate): October 18, 2010

Study Record Updates

• Last Update Posted (Estimate): February 25, 2015
• Last Update Submitted That Met QC Criteria: February 24, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Keywords: Spasticity, Spinal Cord Injury
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Wounds and Injuries; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Neuromuscular Manifestations; Trauma, Nervous System; Spinal Cord Diseases; Muscle Hypertonia; Neuralgia; Spinal Cord Injuries; Muscle Spasticity; Physiological Effects of Drugs; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Tranquilizing Agents; Psychotropic Drugs; Anti-Anxiety Agents; Nabilone
• Other Study ID Numbers: 1976