Efficacy and Safety of Amantadine Hydrogen Chloride (HCl) ER Tablets in Parkinson's Disease Subjects With LID

Summary

The purpose of this multi-center, randomized, double-blind, parallel-group, 26 week study is to compare the efficacy and safety of two different dose levels of Amantadine Extended Release Tablets to placebo for the treatment of levodopa induced dyskinesia in patients with Parkinson's disease.

Timeline

Start

2014-07-30

Primary completion

2016-05-20

Completion

2016-05-20

Outcome

Met primary endpoint

registry analysis (superiority test); 240mg Amantadine HCl ER Tablets; p = 0.031; Mean Difference (Final Values) -5.5 (95% CI -10.5 to -0.5); ANCOVA NCT02153632 ↗

registry analysis (superiority test); 320mg Amantadine HCl ER Tablets; p = 0.011; Mean Difference (Final Values) -6.5 (95% CI -11.5 to -1.5); ANCOVA NCT02153632 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Amantadine	Unknown	240 mg	—
Subject	Amantadine	Unknown	320 mg	—

Indications