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

NCT ID: NCT01222468

Last Updated: 2015-02-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2015-02-28

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

nabilone 0.5 mg

Intervention Type: DRUG

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

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

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

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

Interventions

nabilone 0.5 mg

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

Intervention Type: DRUG

placebo

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

Intervention Type: DRUG

Other Intervention Names

Cesamet

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Manitoba Spinal Cord Injury Research Fund

UNKNOWN

Sponsor Role: collaborator

Canadian Paraplegic Association

OTHER

Sponsor Role: collaborator

Health Sciences Centre Foundation, Manitoba

OTHER

Sponsor Role: collaborator

University of Manitoba

OTHER

Sponsor Role: lead

Responsible Party

Dr. Karen Ethans

Principal Investigator MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Karen D. Ethans, MD

Role: PRINCIPAL_INVESTIGATOR

University of Manitoba

Locations

Health Sciences Centre Rehabilitation Hospital

Winnipeg, Manitoba, Canada

Countries

Canada

Other Identifiers

1976

Identifier Type: -

Identifier Source: org_study_id