Abstract Details

Title An Ongoing Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Arbaclofen Placarbil in Subjects with Spasticity Due to Multiple Sclerosis

Topic Neural Repair/Rehabilitation

Presentation(s) P03 - (-)

Poster/Presentation
Number 267

Objective

Background BACKGROUND: An estimated 80% of MS patients have spasticity, which can severely impair function. Baclofen, a racemate (mixture of R- and S- isomers), is a well-established spasticity treatment but is sometimes intolerable and requires frequent dosing (short half-life). AP is a prodrug of R-baclofen formulated in a sustained-release tablet. A previous Phase 2 trial in spinal cord injury subjects with spasticity demonstrated that AP administered BID provided sustained efficacy and was well tolerated.

Design/Methods DESIGN/METHODS: This randomized, double-blind, placebo-controlled, multicenter study enrolling MS subjects with a Maximum Ashworth Scale Score (MASS) of ?2 in at least one muscle group in the lower extremities, an Expanded Disability Status Scale Score (EDSS) of 3.0-8.0, and a Spasticity Disability Rating (SDR) of ?2. Following a 21-day washout of anti-spasticity drugs and a 7-day, single-blind placebo run-in, eligible subjects were randomized 1:1:1:1 to BID dosing with 15 mg, 30 mg, or 45 mg AP, or matching placebo, for 12 weeks. The co-primary endpoints are change from baseline at Week 10 in MASS (six hours post dose) and the Patient Global Impression of Change.

Results RESULTS: Demographics of 182 randomized subjects (91% of targeted enrollment): mean (SD) age 52.5 (9.2), 62.6% women, and 90.1% white. Mean (SD) baseline values are 2.6 (0.74) for MASS (6 hours post dose in placebo run-in); 3.2 (0.81) for SDR; and 5.3 (1.50) for EDSS. Efficacy and safety results will be presented.

Conclusions CONCLUSIONS: This trial is designed to demonstrate whether BID AP can provide sustained relief of spasticity with good tolerability in MS patients. If successful, it could support further development of AP for treatment of spasticity.

Authors/Disclosures
Timothy L. Vollmer, MD, FAAN PRESENTER	The institution of Dr. Vollmer has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Biogen IDEC. The institution of Dr. Vollmer has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Genentech/Roche. The institution of Dr. Vollmer has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Siranax. The institution of Dr. Vollmer has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Celgene. The institution of Dr. Vollmer has received personal compensation in the range of $500-$4,999 for serving as a Consultant for EMD Serono. The institution of Dr. Vollmer has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Bristol Meyers Squib. The institution of Dr. Vollmer has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Viela Bios. The institution of Dr. Vollmer has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. The institution of Dr. Vollmer has received research support from Rocky Mountain MS Center. The institution of Dr. Vollmer has received research support from Biogen. The institution of Dr. Vollmer has received research support from Actelion. The institution of Dr. Vollmer has received research support from Genentech/Roche. The institution of Dr. Vollmer has received research support from Anokion. The institution of Dr. Vollmer has received research support from TG Therapeutics.
	No disclosure on file
	No disclosure on file
Sarlota Mesaros	Sarlota Mesaros has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche. Sarlota Mesaros has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Astra Zeneca. Sarlota Mesaros has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Novartis. Sarlota Mesaros has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Hemofarm. Sarlota Mesaros has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Merck.
Aaron Ellenbogen, DO	Dr. Ellenbogen has received personal compensation in the range of $100,000-$499,999 for serving as a Consultant for allergan. Dr. Ellenbogen has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for allergan. Dr. Ellenbogen has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Teva. Dr. Ellenbogen has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Supernus. Dr. Ellenbogen has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for ipsen. Dr. Ellenbogen has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Acorda.
Stephen S. Flitman, MD (Xenoscience)	No disclosure on file
James E. Garrison III, MD (Innovative Clinical Trials)	No disclosure on file
John R. Huddlestone, MD (Multicare Medical Center)	No disclosure on file
Cynthia L. Huffman, MD	No disclosure on file
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.
Nirav S. Patel, MD, FAAN (Southland Neurological Institute)	No disclosure on file
James M. Patton, MD (Ashville Neurology Specialists)	No disclosure on file
Ben W. Thrower, MD (Shepherd Center)	Dr. Thrower has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Abbvie. Dr. Thrower has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Genentech. Dr. Thrower has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Horizon. Dr. Thrower has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for BMS.
Dmitri V. Lissin, MD (Scilex Holding)	Dr. Lissin has received personal compensation in the range of $500,000-$999,999 for serving as a Chief Medical Officer with Scilex Holding .

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