The following article is part of conference coverage from the 2019 Annual Meeting of the Consortium of Multiple Sclerosis Centers, in Seattle, Washington. Neurology Advisor‘s staff will be reporting breaking news associated with research conducted by leading experts in neurology. Check back for the latest news from CMSC 2019.
SEATTLE — The INROADS study was designed to assess the effectiveness of ADS-5102 therapy to treat patients with multiple sclerosis and walking impairment. This research was presented at the 2019 CMSC Annual Meeting, held May 28 to June 1, 2019, in Seattle, Washington.
The investigators of this Phase 3 study sought to evaluate the efficacy and safety of ADS-5102 (amantadine) extended-release capsules to treat multiple sclerosis patients with walking impairment. The study included 196 patients who were randomly assigned 1:1:1 to receive placebo, ADS-5102 137 mg, or ADS-5102 274 mg for a 12-week double-blind intervention period after a 4-week placebo run-in period.
The primary end point was the proportion of responders to complete the 25-Foot Walk Test in 8 to 45 seconds. Other outcomes included the Timed Up and Go Test, 2-Minute Walk Test, and the 12-item Multiple Sclerosis Walking Scale. The majority of the study population had relapsing-remitting multiple sclerosis (74.5%) and previously used dalfampridine (48.5%) and amantadine immediate release therapy (15.3%). Participants had a median baseline Expanded Disability Status Scale score of 6.0 and achieved a mean 12.9 seconds on the 25-Foot Walk Test, 18.1 seconds on the Timed Up and Go Test, walked 79.5 feet in the 2-Minute Walk Test, and scored 61.2 on the 12-item Multiple Sclerosis Walking Scale.
Using complementary clinician-assessed measures, including walking speed, functional mobility, and walking distance, the investigators suggest the INROADS study is effective to confirm the potential benefit of ADS-5102 for walking in patients with multiple sclerosis.
Multiple authors report affiliations with Adamas Pharmaceuticals and other companies.
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Cameron MH, Cohen JA, Miller AE, et al. INROADS: A phase 3 study to assess the efficacy and safety of ADS-5102 (amantadine) extended-release capsules in multiple sclerosis patients with walking impairment. Presented at: 2019 CMSC Annual Meeting; May 28 to June 1, 2019; Seattle, WA. Abstract DXA01.