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

• Status: Completed
• Trial end date: 2012-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Manitoba
• Collaborators: Bausch Health Americas, Inc.; Valeant Pharmaceuticals International, Inc.
• Treatments: Dronabinol; Gabapentin; Nabilone

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