NCT03436199

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

A 3-arm, Multicenter, Double-blind, Placebo-controlled, Randomized Study to Assess the Efficacy and Safety of ADS-5102 Amantadine Extended Release Capsules in Multiple Sclerosis Patients With Walking Impairment

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 558 (actual)
• Sponsor: Adamas Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This was a multicenter, 3-arm, randomized, placebo-controlled, double-blind, parallel-group study of ADS-5102 (amantadine) extended release capsules in MS subjects with walking impairment. The study consisted of a screening period (up to 3 weeks), a single-blind placebo run-in period (4 weeks; during which subjects were blinded to treatment), and a double-blind treatment period (12 weeks). For at least 30 days prior to screening, all subjects were to have received a stable regimen of MS medications, both disease-modifying and symptomatic; these medications were to continue at the same doses and regimens for the duration of the subjects' participation in the study, to the extent compatible with good neurological care. Subjects were not to have used amantadine, dalfampridine, or any 4 aminopyridine or 2,4 diaminopyridine preparation within 30 days prior to screening. Consented subjects who completed the screening period were to undergo a 4-week single-blind placebo run-in period during which they received placebo as 2 capsules once daily at bedtime. Subjects who completed the single-blind placebo run-in period and continued to meet study eligibility criteria were randomized with equal probability to 1 of 3 treatment groups: placebo or ADS-5102 at a final dose of 137 mg/day or 274 mg/day. Study drugs were administered as 2 capsules once daily at bedtime. Subjects were to return to the clinic for safety and efficacy assessments at Week 0 and Week 2 prior to randomization and at Weeks 4 (randomization and baseline visit), 6 (only safety), 8, 12, and 16 after randomization. In addition, telephone visits for safety assessments were conducted at Weeks 5 and 7. Subjects who withdrew from the study before Week 16 were to have an early termination visit that included safety follow-up and efficacy assessments, as appropriate.

Conditions

• Walking Impairment
• Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	ADS-5102, 137 mg	Oral capsules
DRUG	ADS-5102, 274 mg	Oral capsules
OTHER	Placebo	Oral capsules

Timeline

• Start date: 2018-03-29
• Primary completion: 2019-12-10
• Completion: 2019-12-10
• First posted: 2018-02-19
• Last updated: 2021-12-21
• Results posted: 2021-12-21

Locations

84 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study