Abstract Details

Title INROADS: A Phase 3 Study to Assess the Efficacy and Safety of ADS-5102 (Amantadine) Extended Release Capsules in Multiple Sclerosis (MS) Patients with Walking Impairment

Topic Multiple Sclerosis

Presentation(s) P5 - Poster Session 5 (5:30 PM-6:30 PM)

Poster/Presentation
Number 15-087

Objective Evaluate the efficacy and safety of ADS-5102 in MS patients with walking impairment as measured by Timed 25-Foot Walk (T25W), Timed Up and Go (TUG), 2-Minute Walk Test (2MWT), and the 12-item Multiple Sclerosis Walking Scale (MSWS-12).

Background

ADS-5102, currently FDA-approved for the treatment of dyskinesia in Parkinson’s disease, is designed to be taken once daily at bedtime and provides high amantadine concentrations upon waking and throughout the day. Based on the results of a 4-week proof-of-concept study in 60 subjects, the INROADS study was designed to confirm the benefit of ADS-5102 for walking in MS.

Design/Methods INROADS is a 16-week study, with a 4-week placebo run-in period followed by a 12-week double-blind period. Subjects (180/group) are randomized 1:1:1 to double-blind treatment (placebo, 137 mg ADS-5102, or 274 mg ADS-5102). The primary endpoint is the proportion of responders (≥20% improvement in the T25FW at Week 16; 274 mg ADS-5102 versus placebo). Additional outcome measures include the TUG, 2MWT, and MSWS-12.

Results The first study participant enrolled on March 29, 2018. As of October 1, 2018, 93 subjects were randomized, with a mean (range) age of 55.6 (35-70) years, a mean (range) duration of MS of 17.1 (0.4-43.0) years, most with relapsing remitting MS (72.0%). Subjects had a median EDSS score of 6.0, a mean T25FW of 12.6 seconds, TUG of 18.2 seconds, 2MWT of 79.7 feet, and MSWS-12 of 61.4. Dalfampridine and amantadine immediate release (IR) had been previously used by 52.7% and 16.1% of subjects, respectively.

Conclusions

Noteworthy design elements of this study are: inclusion of complementary clinician-assessed measures of walking speed, functional mobility, and walking distance, dose evaluation and gradual titration of ADS-5102, and inclusion of patients with a history of dalfampridine and amantadine IR use. This trial will assess the potential benefit of ADS-5102 for walking in MS.

Authors/Disclosures
Michelle Cameron, MD (Oregon Health and Science University) PRESENTER	Dr. Cameron has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Greenwich Biosciences/Jazz . Dr. Cameron has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Adamas Pharmaceuticals. Dr. Cameron has received personal compensation in the range of $0-$499 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Springer. The institution of Dr. Cameron has received research support from National MS Society. The institution of Dr. Cameron has received research support from Department of Veterans Affairs. Dr. Cameron has received publishing royalties from a publication relating to health care.
Jeffrey A. Cohen, MD (Cleveland Clinic)	Dr. Cohen has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Convelo. Dr. Cohen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Astoria. Dr. Cohen has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Bristol Myers Squibb. Dr. Cohen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Viatris. Dr. Cohen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for PSI. Dr. Cohen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Shionogi. Dr. Cohen has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Celltrion.
Aaron E. Miller, MD, FAAN (Mt Sinai School Of Med)	Dr. Miller has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Accordant Health Services (Caremark). Dr. Miller has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Corevitas (formerly known as Corrona). Dr. Miller has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for MAPI=Pharma. Dr. Miller has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Viatris (Mylan). Dr. Miller has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Guidepoint Global. Dr. Miller has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Gerson Lehrman Group. Dr. Miller has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Biogen Idec. Dr. Miller has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Alexion. Dr. Miller has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Amgen (Horizon Therapeutics). Dr. Miller has received personal compensation in the range of $50,000-$99,999 for serving as an Expert Witness for Sterne Kessler. Dr. Miller has received publishing royalties from a publication relating to health care.
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.
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 Genentec. 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 $5,000-$9,999 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 Kiniska. Dr. Goldman has received personal compensation in the range of $500-$4,999 for serving as a Consultant for TG Therapeutics. 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., . Dr. Goldman has received personal compensation in the range of $500-$4,999 for serving as a Study Section Member with NIH. Dr. Goldman has received personal compensation in the range of $0-$499 for serving as a Grant Review Committee Member with Department of Defense.
	No disclosure on file
	No disclosure on file
Larissa Felt	No disclosure on file
Rajiv Patni, MD (Adamas Pharmaceutials)	No disclosure on file

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