NCT02153632

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

A Multicenter, Randomized, Placebo-controlled, Double-blind, 26 Week Study to Evaluate the Efficacy and Safety of Amantadine HCl Extended Release Tablets in Parkinson's Disease Subjects With Levodopa-Induced Dyskinesias

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 135 (actual)
• Sponsor: Adamas Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 30 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study was terminated early due to slow enrollment with 135 of 162 planned subjects enrolled. Amantadine HCl ER has been used for many years as a treatment for Parkinson's disease. It has been reported in the literature to effectively treat the motor complications of levodopa, especially dyskinesia, but it must be given 2 to 4 times a day. 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. The dose will be given once a day in the morning so that amantadine concentrations are maintained throughout the day for treating the levodopa induced dyskinesia, but will be lower during the night, potentially reducing the negative impact of amantadine on sleep.

Conditions

• Parkinson's Disease
• Levodopa Induced Dyskinesia (LID)

Interventions

Type	Name	Description
DRUG	amantadine HCl ER	Subjects are given either 240 mg amantadine HCl ER tablet or 320 mg amantadine HCl ER tablet
DRUG	Placebo	subjects are given an identical placebo tablet

Timeline

• Start date: 2014-07-30
• Primary completion: 2016-05-20
• Completion: 2016-05-20
• First posted: 2014-06-03
• Last updated: 2022-02-16
• Results posted: 2019-04-02

Locations

56 sites across 5 countries: United States, Canada, France, Germany, Spain