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

NCT01222468 | Completed Phase 2

• 1 other identifier: 1976
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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).

Conditions

Muscle Spasticity as a Result of Spinal Cord Injury

Keywords

Spasticity, Spinal Cord Injury

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• Sum of the Ashworth Scale in the eight muscle groups of each side of the body.

  26 weeks

• Penn Spasm Frequency Scale

  26 weeks

• Visual Analog Scale

  26 weeks

• Pittsburgh Sleep Quality Index

  26 weeks

• Subject's Global Impression of Change

  26 weeks

Study Arms (2)

nabilone

ACTIVE COMPARATOR

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

placebo

PLACEBO COMPARATOR

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

Interventions

nabilone 0.5 mg DRUG

nabilone 0.5 mg tablets od titrated to a maximum daily dose of 3mg po over an 11-week phase

Also known as: Cesamet

nabilone

placebo DRUG

placebo 0.5 mg po daily, dose titrated to a maximum daily dose of 3.0mg po over an 11-week phase

placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Spinal Cord Injury
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Manitoba: lead
• The Manitoba Spinal Cord Injury Research Fund: collaborator
• Canadian Paraplegic Association: collaborator
• Health Sciences Centre Foundation, Manitoba: collaborator

Study Sites (1)

Health Sciences Centre Rehabilitation Hospital

Winnipeg, Manitoba, R3A 1M4, Canada

Location

MeSH Terms

Conditions

Muscle Spasticity; Spinal Cord Injuries

Interventions

nabilone

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinal Cord Diseases; Central Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Karen D. Ethans, MD

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator MD

Study Record Dates

• First Submitted: October 14, 2010
• First Posted: October 18, 2010
• Study Start: June 1, 2012
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: February 25, 2015

Record last verified: 2015-02

Locations

CA (1)