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Adamas Pharmaceuticals Presents Positive Clinical Data For ADS-5102, A Treatment For Levodopa-Induced Dyskinesia, At The World Parkinson's Congress
Date:10/2/2013

Study
The EASED study was a randomized, double-blind, placebo-controlled clinical trial that enrolled 83 Parkinson's disease subjects at 31 study sites in the US.  The study's primary efficacy analysis compared ADS-5102 to placebo for reduction in LID over eight 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 260 mg, 340 mg, or 420 mg doses of ADS-5102 or placebo once-nightly for eight weeks with a two-week safety follow-up.  In order to participate in the study, subjects had to have a score of at least 2 on Part IV, item 4.2 (functional impact of dyskinesia) of the MDS-UPDRS at screening and Day 1, and be experiencing at least two 30 minute intervals of ON time with troublesome dyskinesia between the hours of 9 am-4 pm.  Safety measures included adverse events and routine safety laboratory tests that were reviewed during the study by an independent data monitoring committee.

About ADS-5102 (Nurelin)
ADS-5102 is a proprietary, investigational, long-acting formulation of amantadine HCl in development for the treatment of central nervous system (CNS) disorders, including LID in Parkinson's disease.  Administered once-nightly at bedtime, ADS-5102 provides a slow initial increase in amantadine plasma concentration, resulting in high plasma concentration during daytime hours when LID can be troublesome and low concentration overnight.&#
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SOURCE Adamas Pharmaceuticals, Inc.
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