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

NCT ID: NCT00480181

Last Updated: 2012-07-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-06-30
• Study Completion Date: 2012-07-31

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.

Conditions

Neuropathic Pain; Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Active

Group Type: EXPERIMENTAL

nabilone

Intervention Type: DRUG

Cesamet (nabilone) capsules given at titrating dosages as per protocol.

placebo

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: OTHER

placebo capsules (identical appearance to Cesamet) given at titrating dosages as per protocol.

Interventions

nabilone

Cesamet (nabilone) capsules given at titrating dosages as per protocol.

Intervention Type: DRUG

placebo

placebo capsules (identical appearance to Cesamet) given at titrating dosages as per protocol.

Intervention Type: OTHER

Other Intervention Names

Cesamet

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bausch Health Americas, Inc.

INDUSTRY

Sponsor Role: collaborator

University of Manitoba

OTHER

Sponsor Role: lead

Responsible Party

University of Manitoba

Principal Investigators

Michael P Namaka, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Manitoba

Locations

Health Sciences Centre Multiple Sclerosis Clinic

Winnipeg, Manitoba, Canada

Countries

Canada

Other Identifiers

B2007:051

Identifier Type: -

Identifier Source: org_study_id