Conditions: Parkinson's Disease Levodopa Induced Dyskinesia (LID)
Keywords: Parkinson's Disease Levodopa Induced Dyskinesia (LID) LID Parkinsonism Dyskinesia
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 135
Healthy volunteers: no

Brief 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.

Arms:
arm 1: amantadine HCl ER, 240 mg tablets, once daily, 22 weeks arm 2: amantadine HCl ER, 320 mg tablets, once daily, 22 weeks arm 3: Placebo, tablets, once daily, 26 weeks.

Interventions: intervention 1: amantadine HCl ER intervention 2: Placebo
Intervention descriptions: intervention 1: Subjects are given either 240 mg amantadine HCl ER tablet or 320 mg amantadine HCl ER tablet intervention 2: subjects are given an identical placebo tablet

Protocol document: