Last updated on February 2016

Efficacy and Safety of Amantadine HCl Extended Release Tablets in Parkinson's Disease Subjects With Levodopa-Induced Dyskinesias


Brief description of study

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.

Clinical Study Identifier: NCT02153632

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Angela Dentiste, MBA

Tucson, AZ United States
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Fountain Valley, CA United States
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Irvine, CA United States
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Pasadena, CA United States
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Ventura, CA United States
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Boulder, CO United States
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Hollywood, FL United States
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Miami, FL United States
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North Palm Beach, FL United States
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Sarasota, FL United States
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Tampa, FL United States
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Chicago, IL United States
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Indianapolis, IN United States
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Lexington, KY United States
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Baton Rouge, LA United States
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Ann Arbor, MI United States
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Summit, NJ United States
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Brooklyn, NY United States
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Patchogue, NY United States
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Raleigh, NC United States
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Columbus, OH United States
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Round Rock, TX United States
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Orem, UT United States
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Kirkland, WA United States
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Angela Dentiste, MBA

Clermont-Ferrand, France
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Angela Dentiste, MBA

Hindenburgdamm, Germany
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