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NCT Number: NCT01222468

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).

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Key information

Conditions

Muscle Spasticity as a Result of Spinal Cord Injury Central Nervous System Diseases Muscle Hypertonia Muscle Spasticity Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Health Sciences Centre Rehabilitation Hospital

Winnipeg, Manitoba, R3A 1M4, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: Cesamet

Placebo

Drug

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Manitoba

Other

Collaborators

  • Canadian Paraplegic Association
  • Health Sciences Centre Foundation, Manitoba
  • The Manitoba Spinal Cord Injury Research Fund

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Oct 18, 2010
Registry last updated
Feb 25, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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