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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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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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

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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

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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

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Neuropathic Pain Multiple Sclerosis

Keywords

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Neuropathic pain Multiple Sclerosis Nabilone Gabapentin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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

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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

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Cesamet

Eligibility Criteria

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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

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Bausch Health Americas, Inc.

INDUSTRY

Sponsor Role collaborator

University of Manitoba

OTHER

Sponsor Role lead

Responsible Party

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University of Manitoba

Principal Investigators

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Michael P Namaka, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Manitoba

Locations

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Health Sciences Centre Multiple Sclerosis Clinic

Winnipeg, Manitoba, Canada

Site Status

Countries

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Canada

Other Identifiers

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B2007:051

Identifier Type: -

Identifier Source: org_study_id