NCT02471222

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

Safety and Efficacy of ADS-5102 (Amantadine HCl) Extended Release Capsules in Patients With Multiple Sclerosis and Walking Impairment

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Adamas Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a multi-center, randomized, double-blind, placebo-controlled, 2-arm, parallel group study of ADS-5102 extended release (ER) capsules, an investigational formulation of amantadine, dosed once daily at bedtime for the treatment of walking impairment in MS. ADS-5102 is designed to be administered once daily at bed time, ADS-5102 achieves higher plasma amantadine concentrations in the early morning, sustained throughout the afternoon, and lower concentrations in the evening when patients are sleeping. ADS-5102 is designed to deliver its primary treatment effect during the day, and potentially reduce the adverse events of immediate-release amantadine when the patient is asleep.

Conditions

• Walking Impairment
• Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	ADS-5102	Oral capsules to be administered once daily at bedtime for 4 weeks
OTHER	Placebo	Oral capsules to be administered once daily at bedtime for 4 weeks

Timeline

• Start date: 2015-05-01
• Primary completion: 2016-06-01
• Completion: 2016-06-01
• First posted: 2015-06-15
• Last updated: 2017-08-08

Locations

15 sites across 1 country: United States