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Adamas Pharmaceuticals To Report Positive Phase 2/3 Results For ADS-5102 For The Treatment Of Levodopa-Induced Dyskinesia In Parkinson's Disease
Date:6/10/2013

's disease subjects at 31 study sites in the US (NCT 01397422).  The study's primary efficacy analysis compared ADS-5102 to placebo for reduction in LID over 8 weeks as assessed by the Unified Dyskinesia Rating Scale (UDysRS).  Secondary efficacy outcome measures included changes in a standardized PD diary, including "on time" without troublesome dyskinesia; overall PD clinical status as assessed by the MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS); and fatigue measured using the Fatigue Severity Scale.  The EASED trial also included an assessment of dose response for ADS-5102.  The study enrolled male and female subjects aged 30 to 85 years who had Parkinson's disease and were experiencing troublesome LID.  Study participants were randomized to receive a low, medium or high dose of ADS-5102 or placebo once-nightly for eight weeks with a two-week safety follow-up.  Safety measures included adverse events and routine safety laboratory tests that were reviewed during the study by an independent data monitoring committee.  Additional information about the study will be presented in the poster.

About ADS-5102 (Nurelin™)
ADS-5102 is a proprietary, investigational, extended-release formulation of amantadine HCl in development for the treatment of central nervous system (CNS) disorders, including LID in Parkinson's disease.  Designed for once-nightly administration, ADS-5102's unique "chronotherapeutic" profile is characterized by a slow increase in amantadine plasma concentrations, expected to result in high plasma concentrations during the daytime hours when LID can be troublesome, and low plasma concentrations overnight.  The low overnight amantadine plasma concentration may reduce the insomnia, sleep disturbances, and vivid dreams occasionally associated with amantadine.  Due to its altered pharmacokinetic profile, ADS-5102 is being investigated in clinical studies at daily dose strengths gre
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SOURCE Adamas Pharmaceuticals, Inc.
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