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)”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: January 2009

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.

Intervention(s) in this Clinical Trial

• Drug: nabilone
  • Cesamet (nabilone) capsules given at titrating dosages as per protocol.
• Other: placebo
  • placebo capsules (identical appearance to Cesamet) given at titrating dosages as per protocol.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Active
• Placebo Comparator: placebo

Primary Measures

• VAS
  • Time Frame: 9 weeks
    Safety Issue?: No

Secondary Measures

• SF MPQ
  • Time Frame: 9 weeks
    Safety Issue?: No
• SF-36
  • Time Frame: 9 weeks
    Safety Issue?: No
• PGIC
  • Time Frame: 9 weeks
    Safety Issue?: 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: University of Manitoba

Overall Clinical Trial Officials and Contacts

Michael P Namaka, PhD Principal Investigator University of Manitoba  

Overall Contact: Michael P Namaka, PhD (204)474-8380 namakamp@ms.umanitoba.ca

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00480181

Study ID Number: B2007:051

ClinicalTrials.gov Identifier: NCT00480181

Health Authority: Canada: Biomedical Research Ethics Board