Abstract Details

Title Changes in Gait, Walking, and Balance Parameters after Withdrawal and Re-Initiation of Dalfampridine Extended Release Tablets in Patients with Multiple Sclerosis: Results from the STEADY Study

Topic MS and Related Diseases

Presentation(s) P04 - (-)

Poster/Presentation
Number 103

Objective

Background BACKGROUND: In clinical trials, D-ER, 10mg twice daily, improved walking speed relative to baseline in a subset of responsive patients with MS.

Design/Methods DESIGN/METHODS: STEADY was an open-label, single-center study of Timed 25-Foot Walk (T25FW) responders defined prior to study entry as patients showing improvement between off-drug and on-drug T25FW evaluations. Multiple gait domains were measured using NeuroCom SMARTTM Balance Master, an objective evaluation of sensory and motor components of gait and balance. On-drug evaluations were performed at screening and 1-week post-screening (baseline;Period-1); D-ER withdrawal and off-drug evaluations, Days 5 and 11 (Period-2); and D-ER re-initiation and final on-drug evaluation, Day 15 (Period-3). The primary endpoint was a composite gait score based on NeuroCom gait components. Change in balance was evaluated only if gait outcome was significant. Secondary endpoints were changes in walking speed (T25FW) and distance (2-Minute Walk test [2MW]), and balance (Berg Balance Scale [BBS]) during the study periods. A mixed-model ANOVA compared drug effects.

Results RESULTS: 20 subjects enrolled and completed the study; mean time on D-ER 315.3 days; mean age 53.1 years; 60% female; 65% relapsing remitting MS. Gait composite score (mean±SE) worsened after D-ER withdrawal but not significantly (46.01±5.30) relative to Period-1 (50.98±4.88;P=0.124), but significantly improved after reinitiation (52.24±5.10;P=0.032). Treatment difference in gait composite score while on drug was 4.04±1.51 points (P=0.015). No significant difference in overall balance score was observed. Significant changes were observed while on drug for T25FW (0.36 ft/sec;P<0.001), 2MWT (25.36 ft;P=0.006), and BBS (1.7 points;P=0.003). Tolerability was consistent with previous studies.

Conclusions CONCLUSIONS: D-ER showed positive and significant effects on gait, walking speed and distance, and balance, as demonstrated by D-ER withdrawal and reinitiation.

Authors/Disclosures
Cecilie Fjeldstad, PhD (OMRF Multiple Sclerosis Cetner of Excellence) PRESENTER	No disclosure on file
Gabriel Pardo, MD, FAAN (Oklahoma Medical Research Foundation)	Dr. Pardo has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Roche Genentech. Dr. Pardo has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Sanofi Genzyme. Dr. Pardo has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for EMD Serono. Dr. Pardo has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Novartis. Dr. Pardo has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for TG Therapeutics. Dr. Pardo has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Amgen . Dr. Pardo has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Bristol Myers Squibb. Dr. Pardo has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for EMD Serono. Dr. Pardo has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Novartis. Dr. Pardo has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Roche Genentech. Dr. Pardo has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Sanofi Genzyme. Dr. Pardo has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for TG Therapeutics. Dr. Pardo has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Amgen. Dr. Pardo has or had stock in Progentec Diagnostics.Dr. Pardo has or had stock in Cadenza Bio.
	No disclosure on file
	No disclosure on file
Herbert Henney, PharmD (Acorda Therapeutics, Inc.)	No disclosure on file
Adrian L. Rabinowicz, MD, FAAN (Neurelis, Inc.; Center for Molecular Biology and Biotechnology, Charles E. Schmidt College of Science, Florida Atlantic University)	Dr. Rabinowicz has received personal compensation for serving as an employee of Neurelis, Inc. Dr. Rabinowicz has stock in Neurelis, Inc.
Ming-Yi Huang	No disclosure on file

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