Abstract Details

Title Effects of 5mg and 10mg Dalfampridine Extended Release Tablets on 6-Minute Walk Distance in People with Multiple Sclerosis: A Subgroup Analysis of a Double-Blind, Placebo-Controlled Trial

Topic MS and Related Diseases

Presentation(s) S01 - (-)

Poster/Presentation
Number 007

Background Dalfampridine-ER 10mg tablets, twice daily, are approved to improve walking in patients with multiple sclerosis (MS). A study comparing dalfampridine-ER 5mg and 10mg tablets was required as an FDA post-marketing commitment. A subset of sites included the 6MW test as a pre-specified secondary endpoint in addition to the primary endpoint based on the Timed 25-Foot Walk (T25FW).

Objective

Design/Methods Participants were randomized to 4-week, double-blind, twice-daily treatment with dalfampridine-ER 5mg (n=144), 10mg (n=143), or placebo (n=143). This analysis reports 6MW data for the subset of subjects who completed these assessments (n=49, placebo; n=53, dalfampridine-ER 5mg; n=51, dalfampridine-ER 10mg). The 6MW test was administered once before treatment, and once after 2 weeks on treatment. Treatment effects were compared using an ANOVA model, with change from baseline as the dependent variable and baseline and treatment as independent variables.

Results For subjects who completed the 6MW, demographic characteristics and baseline efficacy variables were not significantly different among treatments; baseline 6MW distance (mean±SE) was 847.4±58.0 ft for placebo, 840.2±44.3 ft for dalfampridine-ER 5mg, and 860.7±45.0 ft for dalfampridine-ER 10mg. While the 2-week change from baseline (mean±SE) in walking distance was numerically higher with dalfampridine-ER 5mg (76.8±27.3 ft) relative to placebo (41.7±23.4 ft), the difference was not significant (P=0.308). However, the improvement on the 6MW with dalfampridine-ER 10 mg (128.6±21.7 ft) was significantly greater than placebo (P=0.014).

Conclusions In these subjects with MS, twice daily dalfampridine-ER 10mg but not 5mg significantly improved 6MW distance relative to placebo.

Authors/Disclosures
Angela Applebee, MD (St Peter'S MS Center) PRESENTER	Dr. Applebee has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Biogen. Dr. Applebee has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Genentech. Dr. Applebee has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Genzyme. Dr. Applebee has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Serono. Dr. Applebee has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Horizon. Dr. Applebee has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Bristol Myers Squibb.
Andrew D. Goodman, MD, FAAN (University of Rochester Dept. Neurology)	Dr. Goodman has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Swan Bio. Dr. Goodman has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Genentech. Dr. Goodman has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Janssen. Dr. Goodman has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Lilly. Dr. Goodman has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Dr. Goodman has received personal compensation in the range of $500-$4,999 for serving as a Consultant for TG Therapeutics. Dr. Goodman has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for IMCYSE. Dr. Goodman has received personal compensation in the range of $500-$4,999 for serving as an Expert Witness for Pfizer. The institution of Dr. Goodman has received research support from Atara. The institution of Dr. Goodman has received research support from Genzyme. The institution of Dr. Goodman has received research support from EMD-Serono.
Angeli Mayadev, MD (Multiple Sclerosis Center)	Dr. Mayadev has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Abbvie. The institution of Dr. Mayadev has received research support from Ipsen.
Francois Bethoux, MD (Cleveland Clinic)	No disclosure on file
Myla D. Goldman, MD, MSc, FAAN (Virginia Commonwealth University)	Dr. Goldman has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for EMD Seronon. Dr. Goldman has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Biogen, IDEC. Dr. Goldman has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Genzyme. Dr. Goldman has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Genentec. Dr. Goldman has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for ADAMAS. Dr. Goldman has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Immunic. Dr. Goldman has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis Pharmceuticals. Dr. Goldman has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Greenwich Biosciences. Dr. Goldman has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Merk. Dr. Goldman has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Brainstorm Cell Therapeutics Ltd., .
	No disclosure on file
Herbert Henney, PharmD (Acorda Therapeutics, Inc.)	No disclosure on file
William M. Siders, PhD	No disclosure on file
Andrew Blight, PhD (Acorda Therapeutics, Inc)	No disclosure on file
Enrique J. Carrazana, MD	No disclosure on file

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