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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00480181
Recruitment Status : Completed
First Posted : May 30, 2007
Last Update Posted : July 27, 2012
Valeant Pharmaceuticals International, Inc.
Information provided by:
University of Manitoba

Brief Summary:
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 or disease Intervention/treatment Phase
Neuropathic Pain Multiple Sclerosis Drug: nabilone Other: placebo Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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)
Study Start Date : June 2007
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. VAS [ Time Frame: 9 weeks ]

Secondary Outcome Measures :
  1. SF MPQ [ Time Frame: 9 weeks ]
  2. SF-36 [ Time Frame: 9 weeks ]
  3. PGIC [ Time Frame: 9 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00480181

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

Responsible Party: Dr. M. Namaka, University of Manitoba Identifier: NCT00480181     History of Changes
Other Study ID Numbers: B2007:051
First Posted: May 30, 2007    Key Record Dates
Last Update Posted: July 27, 2012
Last Verified: March 2011

Keywords provided by University of Manitoba:
Neuropathic pain
Multiple Sclerosis

Additional relevant MeSH terms:
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Neurologic Manifestations
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents