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Efficacy and Safety Evaluation of Nabilone as Adjunctive Therapy to Gabapentin for the Management of Neuropathic Pain in Multiple Sclerosis

This study has been completed.
Sponsor:
Collaborator:
Valeant Pharmaceuticals International, Inc.
Information provided by:
University of Manitoba
ClinicalTrials.gov Identifier:
NCT00480181
First received: May 28, 2007
Last updated: July 26, 2012
Last verified: March 2011
History of Changes
  Purpose

The purpose of this study is to determine whether nabilone (Cesamet) when used as an adjunctive agent with gabapentin (Neurontin) provides significantly improved pain relief over gabapentin alone for the management of neuropathic pain in MS.


Condition Intervention Phase
Neuropathic Pain
Multiple Sclerosis
 Drug: nabilone
Other: placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Comparative, Single Center, Randomized, Double-blinded, Parallel, Placebo-controlled Study to Evaluate the Efficacy of Nabilone (Cesamet) as Adjunctive Therapy to Gabapentin (Neurontin) in the Management of Neuropathic Pain (NPP) Symptoms in Subjects With Multiple Sclerosis (MS)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Manitoba:

Primary Outcome Measures:
  • VAS [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • SF MPQ [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
  • SF-36 [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
  • PGIC [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: June 2007
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active Drug: nabilone
Cesamet (nabilone) capsules given at titrating dosages as per protocol.
Other Name: Cesamet
Placebo Comparator: placebo Other: placebo
placebo capsules (identical appearance to Cesamet) given at titrating dosages as per protocol.

Detailed Description:

Neuropathic pain syndromes, which occur due to damage to central and/or peripheral nerve axons, are often more difficult to manage and are commonly refractory to the conventional analgesia approach described by the World Health Organization, including NSAIDs and narcotic agents. These pain syndromes are often described by symptoms of burning, stabbing, crawling, shock-like, numbness and/or tingling, and can be quite concerning to the patient, especially when there is an inadequate response to treatment. It has been estimated that the prevalence of chronic pain in MS ranges anywhere from 30-90%, placing it as the second worst disease-induced symptom experienced by this patient population.

The pathophysiologic causes of this pain syndrome are complex and multifaceted, with no one specific link attributed to the pain response. Due to the complexity of neuropathic pain - which is only partially understood at best - it may be necessary in many cases to treat the source of the pain with more than one agent in order to address the many different contributors to this pain process. More thorough review of how the currently available agents for NPP work together would provide clinicians with safety and efficacy data which would aid in providing optimal pain management.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males and females between the ages of 18-65 years old with clinically definite RRMS
  • EDSS of < 6.5
  • Current treatment with gabapentin that is not effective at a stabilized dose of (>1800mg/day) for at least 1 month.
  • Visual Analogue Scale score for NPP symptoms > 5; pain present for at least 3 months
  • Negative serum pregnancy test for all females of childbearing age; not currently breastfeeding
  • No history of alcohol or substance abuse
  • No history of non-psychotic emotional disorders
  • No significant hepatic or renal insufficiency
  • No significant cardiovascular disease or hypertension
  • No known hypersensitivity and/or allergy to nabilone or its derivatives
  • No current use of cannabinoid or related products
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00480181

Locations
Canada, Manitoba
Health Sciences Centre Multiple Sclerosis Clinic
Winnipeg, Manitoba, Canada, R3A 1R9
Sponsors and Collaborators
University of Manitoba
Valeant Pharmaceuticals International, Inc.
Investigators
Principal Investigator: Michael P Namaka, PhD University of Manitoba
  More Information

No publications provided

Responsible Party: Dr. M. Namaka, University of Manitoba
ClinicalTrials.gov Identifier: NCT00480181     History of Changes
Other Study ID Numbers: B2007:051
Study First Received: May 28, 2007
Last Updated: July 26, 2012
Health Authority: Canada: Biomedical Research Ethics Board

Keywords provided by University of Manitoba:
Neuropathic pain
Multiple Sclerosis
Nabilone
Gabapentin

Additional relevant MeSH terms:
Multiple Sclerosis
Neuralgia
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pain
Neurologic Manifestations
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Pathologic Processes
 Gabapentin
Nabilone
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants
Antiparkinson Agents
Anti-Dyskinesia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013