A Phase 3, double-blind, placebo-controlled efficacy and safety study of ADS-5102 (Amantadine) extended-release capsules in people with multiple sclerosis and walking impairment

Jeffrey A. Cohen, Michelle H. Cameron, Myla D. Goldman, Andrew D. Goodman, Aaron E. Miller, Anne Rollins, Lily Llorens, Rajiv Patni, Robert Elfont, Reed Johnson

Research output: Contribution to journalArticlepeer-review

Abstract

Background: ADS-5102, a delayed-release, extended-release (DR/ER) amantadine, improved walking speed in MS in a Phase 2 trial. Objective: The aim of this study was to present primary results of a Phase 3, double-blind, ADS-5102 trial (INROADS) for walking speed. Methods: Adult participants with MS and walking impairment, not currently using amantadine or dalfampridine, underwent 4-week placebo run-in before randomization 1:1:1 to placebo, 137 or 274 mg/day ADS-5102 for 12 weeks. Primary outcome was the proportion of responders (20% increase in Timed 25-Foot Walk (T25FW) speed) for 274 mg ADS-5102 versus placebo at end of double-blind (Study Week 16). Additional measures included Timed Up and Go (TUG), 2-Minute Walk Test (2MWT), and 12-item Multiple Sclerosis Walking Scale (MSWS-12). Results: In total, 558 participants were randomized and received double-blind treatment. Significantly more participants responded with 274 mg ADS-5102 (21.1%) versus placebo (11.3%). Mean T25FW speed also significantly improved (0.19 ft/s) versus placebo (0.07 ft/s). Other measures were not significant using prespecified hierarchical testing procedure. Adverse events led to discontinuation for 3.8% (placebo), 6.4% (137 mg ADS-5102), and 20.5% (274 mg ADS-5102). Conclusion: INROADS met its primary endpoint, showing a significantly greater proportion of participants with meaningful improvement in walking speed for 274 mg ADS-5102 versus placebo. Numeric dose response was seen for some secondary efficacy outcomes and adverse events.

Original languageEnglish (US)
JournalMultiple Sclerosis Journal
DOIs
StateAccepted/In press - 2021

Keywords

  • 2-Minute Walk Test
  • amantadine
  • Multiple sclerosis
  • Multiple Sclerosis Walking Scale-12
  • randomized controlled trial
  • Timed 25-Foot Walk
  • Timed Up and Go

ASJC Scopus subject areas

  • Neurology
  • Clinical Neurology

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