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

Sponsor

University of Manitoba (Other)

Overall Status

Completed

CT.gov ID

NCT00480181

Collaborator

Bausch Health Americas, Inc. (Industry)

Enrollment

Location

Arms

Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Neuropathic Pain Multiple Sclerosis	Drug: nabilone Other: placebo	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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)

Study Start Date :

Jun 1, 2007

Actual Primary Completion Date :

Jul 1, 2012

Actual Study Completion Date :

Jul 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Active	Drug: nabilone Cesamet (nabilone) capsules given at titrating dosages as per protocol. Other Names: Cesamet
Placebo Comparator: placebo	Other: placebo placebo capsules (identical appearance to Cesamet) given at titrating dosages as per protocol.

Arm

Intervention/Treatment

Experimental: Active

Drug: nabilone

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

Other Names:

Cesamet

Placebo Comparator: placebo

Other: placebo

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

Outcome Measures

Primary Outcome Measures

VAS [9 weeks]

Secondary Outcome Measures

SF MPQ [9 weeks]
SF-36 [9 weeks]
PGIC [9 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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