NCT01397422

Extended Release Amantadine Safety and Efficacy Study in Levodopa-Induced Dyskinesia (EASED Study)

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 83 (actual)
• Sponsor: Adamas Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 30 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This is a multi-center, randomized, double-blind, placebo-controlled, 4-arm parallel group study to evaluate the tolerability and efficacy of each of three dose levels of ADS-5102 oral capsules, an extended release formulation of amantadine, dosed once daily for the treatment of levodopa-induced dyskinesia (LID) in subjects with Parkinson's disease (PD). The novel pharmacokinetic profile of ADS-5102 is expected to achieve i) higher amantadine plasma concentrations during daytime hours when dyskinesia as well as motor and non-motor symptoms of PD are most problematic, ii) low amantadine plasma concentrations overnight, which may reduce the sleep disturbances and vivid dreams occasionally associated with amantadine, and iii) a reduced initial rate of rise in plasma concentration, which is expected to improve overall tolerability of amantadine.

Conditions

• Dyskinesia
• Levodopa Induced Dyskinesia
• Parkinson's Disease

Interventions

Type	Name	Description
DRUG	ADS-5102 (extended release amantadine HCl)	Oral capsules to be administered once daily at bedtime, for 8 weeks

Timeline

• Start date: 2011-07-01
• Primary completion: 2013-05-01
• Completion: 2013-10-01
• First posted: 2011-07-19
• Last updated: 2017-12-13
• Results posted: 2017-11-06

Locations

33 sites across 1 country: United States