The Symptomatic Effect of Gabapentin on Cerebellar Ataxia - A Double Blind Placebo-Controlled Trial (P2.350)

Abstract

OBJECTIVE: To evaluate the effect of gabapentin on cerebellar ataxia in patients with degenerative ataxia and patients with multiple sclerosis. BACKGROUND: Cerebellar ataxia is a severely disabling symptom in a range of diseases, but to date there is no approved symptomatic drug therapy to improve motor incoordination in ataxia disorders. In multiple sclerosis patients gabapentin has been used off-label for cerebellar tremor and few reports suggest an effect of gabapentin on the gabaergic transmission of cerebellar purkinje cells with improvement of coordination in degenerative ataxia. DESIGN/METHOD: We conducted a randomized placebo-controlled double blind trial with 72 ataxia patients (36 placebo versus 36 verum) with subgroups of degenerative ataxia and multiple sclerosis (18 in each group). After a dosing phase of three weeks patients received two to six capsules of verum (600-1800 mg gabapentin) or placebo and were examined again four weeks later. Primary outcome parameter is the video-evaluated clinical SARA score (Scale for the Assessment and Rating of Ataxia), secondary outcome parameters include oculographic test results, a quality of life scale (UHDRS part IV) and safety laboratory parameters. RESULTS: The data aquisition is completed and currently the results are evaluated. We will present the study design with emphasis on video-documentation and first results. CONCLUSION: The trial illustrates the use of video-documentation as important method against bias in an ataxia study. First results on the efficacy of gabapentin in cerebellar ataxia treatment will be presented at the AAN conference. The study was supported by a grant of the German Research Foundation (DFG) to SD

Disclosure: Dr. Doss has nothing to disclose. Dr. Burmester has nothing to disclose. Dr. Wunsch has nothing to disclose. Dr. Neidel has nothing to disclose. Dr. Finke has nothing to disclose. Dr. Paul has received personal compensation for activities with Teva Neuroscience, Sanofi-Aventis Pharmaceuticals, Inc., Bayer Schering Pharma, Merck Serono, Biogen Idec, Medimmune, and Novartis.