Corneliu C Luca1, Gloria Nadayil2, Chuanhui Dong3, Fatta B Nahab4, Edelle Field-Fote5, Carlos Singer3. 1. Department of Neurology, University of Miami, Miami, United States. Electronic address: cluca@med.miami.edu. 2. Florida Atlantic University, Atlanta, United States. 3. Department of Neurology, University of Miami, Miami, United States. 4. University of California San Diego, Atlanta, United States. 5. Shepherd Center, Atlanta, United States.
Abstract
BACKGROUND: Disease-related gait dysfunction causes extensive disability for persons with Parkinson's disease (PD), with no effective therapies currently available. The potassium channel blocker dalfampridine has been used in multiple neurological conditions and improves walking in persons with multiple sclerosis. OBJECTIVES: We aimed to evaluate the effect of dalfampridine extended release (D-ER) 10mg tablets twice daily on different domains of walking in participants with PD. METHODS:Twenty-two participants with PD and gait dysfunction were randomized to receive D-ER 10mg twice daily or placebo for 4weeks in a crossover design with a 2-week washout period. The primary outcomes were change in the gait velocity and stride length. RESULTS: At 4weeks, gait velocity was not significantly different between D-ER (0.89m/s±0.33) and placebo (0.93m/s±0.27) conditions. The stride length was also similar between conditions: 0.96m±0.38 for D-ER versus 1.06m±0.33 for placebo. D-ER was generally well tolerated with the most frequent side effects being dizziness, nausea and balance problems. CONCLUSIONS: D-ER is well tolerated in PD patients, however it did not show significant benefit for gait impairment.
RCT Entities:
BACKGROUND: Disease-related gait dysfunction causes extensive disability for persons with Parkinson's disease (PD), with no effective therapies currently available. The potassium channel blocker dalfampridine has been used in multiple neurological conditions and improves walking in persons with multiple sclerosis. OBJECTIVES: We aimed to evaluate the effect of dalfampridine extended release (D-ER) 10mg tablets twice daily on different domains of walking in participants with PD. METHODS: Twenty-two participants with PD and gait dysfunction were randomized to receive D-ER 10mg twice daily or placebo for 4weeks in a crossover design with a 2-week washout period. The primary outcomes were change in the gait velocity and stride length. RESULTS: At 4weeks, gait velocity was not significantly different between D-ER (0.89m/s±0.33) and placebo (0.93m/s±0.27) conditions. The stride length was also similar between conditions: 0.96m±0.38 for D-ER versus 1.06m±0.33 for placebo. D-ER was generally well tolerated with the most frequent side effects being dizziness, nausea and balance problems. CONCLUSIONS:D-ER is well tolerated in PDpatients, however it did not show significant benefit for gait impairment.
Authors: Wei-Hua Chiu; Lora Kovacheva; Ruth E Musgrove; Hadar Arien-Zakay; James B Koprich; Jonathan M Brotchie; Rami Yaka; Danny Ben-Zvi; Menachem Hanani; Jochen Roeper; Joshua A Goldberg Journal: Sci Adv Date: 2021-03-10 Impact factor: 14.136