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

May 28, 2007
July 26, 2012
June 2007
July 2012   (final data collection date for primary outcome measure)
VAS [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
VAS [ Time Frame: 9 weeks ]
Complete list of historical versions of study NCT00480181 on ClinicalTrials.gov Archive Site
  • 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 ]
  • SF MPQ [ Time Frame: 9 weeks ]
  • SF-36 [ Time Frame: 9 weeks ]
  • PGIC [ Time Frame: 9 weeks ]
Not Provided
Not Provided
 
Efficacy and Safety Evaluation of Nabilone as Adjunctive Therapy to Gabapentin for the Management of Neuropathic Pain in Multiple Sclerosis
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)

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Neuropathic Pain
  • Multiple Sclerosis
  • Drug: nabilone
    Cesamet (nabilone) capsules given at titrating dosages as per protocol.
    Other Name: Cesamet
  • Other: placebo
    placebo capsules (identical appearance to Cesamet) given at titrating dosages as per protocol.
  • Experimental: Active
    Intervention: Drug: nabilone
  • Placebo Comparator: placebo
    Intervention: Other: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
July 2012
July 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00480181
B2007:051
No
Dr. M. Namaka, University of Manitoba
University of Manitoba
Valeant Pharmaceuticals International, Inc.
Principal Investigator: Michael P Namaka, PhD University of Manitoba
University of Manitoba
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP