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Adamas Pharmaceuticals Initiates a Phase 2/3 Clinical Study of ADS-5102 for Parkinson's Disease
Date:9/28/2011

EMERYVILLE, Calif., Sept. 28, 2011 /PRNewswire/ -- Adamas Pharmaceuticals, Inc., a privately held company, announced today that it has initiated a Phase 2/3 clinical trial of its proprietary investigational drug ADS-5102 (amantadine HCl extended release) for the treatment of levodopa induced dyskinesia (LID) in patients with Parkinson's disease.  Called EASED™ (Extended Release Amantadine Safety and Efficacy Study in Levodopa-Induced Dyskinesia), this study will evaluate the safety and effectiveness of three dose levels of ADS-5102 in the treatment of LID.

"Commencement of this Phase 2/3 clinical study of ADS-5102 culminates years of Adamas research into the use of amantadine as a treatment for LID in Parkinson's disease, and represents the first well controlled, rigorously powered study of amantadine aimed at licensure in this indication," said Gregory Went, Ph.D., Chief Executive Officer of Adamas.  "The EASED™ study will build upon our successful Phase 1 studies in healthy volunteers, which confirmed the desired target pharmacokinetic profile and potential tolerability improvement associated with ADS-5102."

Dr. Matthew Stern, Professor of Neurology, University of Pennsylvania, a member of Adamas' Clinical Advisory Board added, "LID represents a significant unmet need in advanced Parkinson's disease. Unfortunately there is no drug approved for this condition and patients face limited treatment options. We know that amantadine has some utility in treating LID in Parkinson's disease – but a well controlled, rigorously powered study of this drug has not been completed to date. "

EASED™ is a randomized, placebo controlled, clinical trial that will enroll up to 80 Parkinson's disease patients at approximately 25 study sites in the US.  The study's primary endpoint is reduction in LID as assessed by changes in the Unified Dy
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SOURCE Adamas Pharmaceuticals, Inc.
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