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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.
 
ClinicalTrials.gov Identifier: NCT00480181
Recruitment Status : Completed
First Posted : May 30, 2007
Last Update Posted : July 27, 2012
Sponsor:
Collaborator:
Bausch Health Americas, Inc.
Information provided by:
University of Manitoba

Tracking Information
First Submitted Date  ICMJE May 28, 2007
First Posted Date  ICMJE May 30, 2007
Last Update Posted Date July 27, 2012
Study Start Date  ICMJE June 2007
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 29, 2007)
VAS [ Time Frame: 9 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 29, 2007)
  • SF MPQ [ Time Frame: 9 weeks ]
  • SF-36 [ Time Frame: 9 weeks ]
  • PGIC [ Time Frame: 9 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety Evaluation of Nabilone as Adjunctive Therapy to Gabapentin for the Management of Neuropathic Pain in Multiple Sclerosis
Official Title  ICMJE 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)
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Neuropathic Pain
  • Multiple Sclerosis
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: Active
    Intervention: Drug: nabilone
  • Placebo Comparator: placebo
    Intervention: Other: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: May 29, 2007)
50
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2012
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00480181
Other Study ID Numbers  ICMJE B2007:051
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. M. Namaka, University of Manitoba
Study Sponsor  ICMJE University of Manitoba
Collaborators  ICMJE Bausch Health Americas, Inc.
Investigators  ICMJE
Principal Investigator: Michael P Namaka, PhD University of Manitoba
PRS Account University of Manitoba
Verification Date March 2011

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