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

University of Manitoba

Status and phase

Completed

Phase 4

Conditions

Multiple Sclerosis

Neuropathic Pain

Treatments

Other: placebo

Drug: nabilone

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00480181

B2007:051

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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