NCT03567057

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 424 (actual)
• Sponsor: Adamas Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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).

Detailed description

This was a multicenter, open-label study of ADS-5102 (amantadine) extended-release capsules in subjects with MS and walking impairment who completed study drug treatment for 16 weeks and completed a Week 16 visit in Study ADS-AMT-MS301. All enrolled subjects were to receive ADS-5102 at 137 mg for the first week, 205.5 mg for the second week, and 274 mg for the remainder of the 52-week open-label treatment period. Subjects returned to the clinic for safety and efficacy assessments at Weeks 4, 24, and 52. In addition, a telephone visit for safety assessments was conducted at Week 2 and Week 38. Subjects who withdrew from the study prior to completion of the Week 52 visit had an early termination (ET) visit that included safety and efficacy assessments. Subjects who completed 52 weeks of open-label treatment had a final visit for post-treatment safety follow-up and efficacy assessment at Week 54. All study visits and efficacy assessments were to be scheduled to occur at approximately the same time of day for each individual subject. Each subject's efficacy assessment was to be performed by the same clinical rater, if possible.

Conditions

• Multiple Sclerosis
• Walking Impairment

Interventions

Type	Name	Description
DRUG	ADS-5102, 274 mg	Oral capsules

Timeline

• Start date: 2018-07-18
• Primary completion: 2020-11-17
• Completion: 2021-04-18
• First posted: 2018-06-25
• Last updated: 2022-01-18
• Results posted: 2022-01-18

Locations

92 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study