CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 424 enrolled
Drug / intervention
ADS-5102, 274 mgdrug
Likely dose
ADS-5102, 274 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03567057
NCT03567057Phase 3Completed
CompareCT.gov

A Multicenter, Open-Label Safety and Efficacy Study of ADS-5102 Amantadine Extended Release Capsules in Patients With Multiple Sclerosis and Walking Impairment

Adamas Pharmaceuticals, Inc.·interventional·Posted Jun 25, 2018·Updated Jan 18, 2022

In Brief

A Phase 3 clinical trial evaluating ADS-5102, 274 mg for Multiple Sclerosis and Walking Impairment. Completed, enrolled 424 participants across 92 sites in 2 countries.

Detailed Summary

This study assessed the long-term safety and tolerability of ADS-5102 in subjects with MS and walking impairment who had completed the double-blind, placebo-controlled study of ADS-5102 in subjects with MS (ADS-AMT-301).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMultiple Sclerosis, Walking Impairment
CountriesCanada, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedJun 25, 2018
Enrollment StartJul 18, 2018
Primary CompletionNov 17, 2020
Study CompletionApr 18, 2021
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 8.0 years ago

Interventions

ADS-5102, 274 mgdrug

Oral capsules