Abstract
Background: Dalfampridine extended-release (dalfampridine-ER) improves walking in people with MS as demonstrated by an improvement in walking speed. This was an exploratory study to evaluate the treatment effect of dalfampridine-ER on gait, balance, and walking changes through treatment withdrawal and reinitiation.
Methods: Dalfampridine-ER responders based on Timed 25-Foot Walk (T25FW) assessment prior to study entry were included in this open-label, 3-period, single-center study. Period 1: on-drug evaluations were performed at screening and 1 week post-screening. Period 2: dalfampridine-ER withdrawal and off-drug evaluations (days 5 and 11). Period 3: dalfampridine-ER reinitiation/final on-drug evaluation (day 15). Primary outcome variables: NeuroCom composite scores for gait and balance using NeuroCom® Long Forceplate and SMART Balance Master®; balance was evaluated only if gait changes were significant. Secondary variables: individual NeuroCom test scores, walking speed (T25FW) and distance (2-Minute Walk Test [2MWT]), and balance (Berg Balance Scale [BBS]).
Results: All 20 patients completed the study: mean age, 53.1 years; mean MS duration, 11.3 ± 8.4 years; mean time on dalfampridine-ER, 315.3 days. NeuroCom gait composite score worsened during Period 2 relative to Period 1, and improved during Period 3; the difference in gait composite score on-drug was 4.03 ± 1.51 points (P = .015). Balance composite score did not change significantly. Improvements were observed for off-drug versus on-drug changes in T25FW (0.36 ft/sec; P < .001), 2MWT (25.36 ft; P = .006), and BBS (1.7 points; P = .003). Safety profile was consistent with previous studies.
Conclusions: Significant improvements in gait, walking speed, distance, and balance were demonstrated by dalfampridine-ER reinitiation following a 10-day withdrawal period. ClinicalTrials.gov (NCT01535664).
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