A Pilot Study of Dalfampridine for Improving Upper Extremity Function in Multiple Sclerosis Patients (P1.124)

OBJECTIVE: To determine if dalfampridine improves upper extremity (UE) function in MS patients. BACKGROUND: Dalfampridine enhances conduction of action potentials in demyelinated nerve fibers in animal models. Based on its mechanism of action and beneficial effects on walking in MS, it seems plausible dalfampridine might improve UE function in MS patients. DESIGN/METHODS: An open-label study was conducted in 20 MS patients with UE weakness. After a 1-week baseline period, subjects received dalfampridine extended release (D-ER) 10 mg b.i.d. for 4 weeks. The primary outcome measure was the TEMPA (Test d’Evaluation de la performance des Membres Superieurs des Personnes Âgees), which has been validated in MS. Secondary outcome measures included grip strength, 9-Hole Peg Test (9HPT), Box and Blocks Test (BBT), motricity index (MI), and the Disabilities of the Arm, Shoulder, and Hand Questionnaire (DASH). RESULTS: 20 subjects (80[percnt] female, mean age 52.5±12 years) with average disease-duration of 12.8±10.5 years and median EDSS of 7 were enrolled; 7 had RRMS, 12 SPMS, and 1 PPMS. During D-ER treatment, there was improvement for the entire cohort in the mean TEMPA functional rating (right (P=0.064), left (P=0.004), bilateral (P=0.057), and combined (P=0.002)) and speed of execution (right (P=0.031), left (P=0.048), bilateral (P=0.170)); MI (right (P=0.001), left (P=0.001)), grip strength (right (P=0.021), left (P=0.042)), BBT (dominant hand (P=0.016), non-dominant hand (P=0.002)) and DASH (P=0.006). We also analyzed the proportion of subjects who improved during D-ER treatment. 72-83[percnt] of subjects showed improvement in the mean TEMPA speed of execution (right (P=0.018), left (P=0.005), bilateral (P=0.018)), MI (right (P=0.059), left (P=0.018)), grip strength (right (P=0.005), left (P=0.059)), BBT (dominant hand (P=0.005), non-dominant hand (P=0.018)), and DASH (P=0.018). Additional data will be presented. CONCLUSIONS: This study provides preliminary evidence for D-ER to improve UE function in MS patients. Study Supported by: Investigator-initiated study supported by Acorda Therapeutics. Disclosure: Dr. Tullman has received personal compensation for activities with Allergan, Inc., Acorda Therapeutics, Biogen Idec, EMD Serono, Novartis, Pfizer Inc. Questcor, Teva Neuroscience, and Genzyme Corporation as a consultant and/or speaker. Dr. Knetzer has nothing to disclose. Dr. Maranzana has nothing to disclose. Dr. Payne-Gates has nothing to disclose. Dr. Popham has received personal compensation for activities with Novartis, EMD Serono, Genzyme, and Teva Neuroscience as a speaker and/or consultant. Dr. Salter has received personal compensation for activities with GlaxoSmithKline as a consultant. Dr. Singer has received personal compensation for activities with Acorda Therapeutics, Bayer Pharmaceuticals Corporation, Biogen Idec, EMD Serono, Genentech, Inc., Genzyme Corporation, Novartis, Pfizer Inc., and Teva Neuroscience.