Safety and Efficacy of ADS-5102 in Multiple Sclerosis Patients With Walking Impairment

Summary

This study assessed the efficacy and safety of ADS-5102 (at daily doses of 137 mg or 274 mg) compared with placebo in MS patients with walking impairment.

Timeline

Start

2018-03-29

Primary completion

2019-12-10

Completion

2019-12-10

Outcome

Met primary endpoint

registry analysis (superiority test); ADS-5102 274 mg vs Placebo; p = 0.0104; Risk Difference (RD) 0.098 (95% CI 0.023 to 0.174); Farrington-Manning score test NCT03436199 ↗

registry NUMBER ADS-5102 274 mg: 0.211 proportion of responders NUMBER Placebo: 0.113 proportion of responders NCT03436199 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Amantadine	Unknown	137 mg	Oral
Subject	Amantadine	Unknown	274 mg	Oral

Indications