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Adamas Pharmaceuticals Presents Positive Phase 2/3 Results For ADS-5102 For The Treatment Of Levodopa-Induced Dyskinesia (LID) In Parkinson's Disease
Date:6/18/2013

otal Objective Score (III, IV); the dose response for the ADS-5102 treatment groups in UDysRS Total Score; MDS-UPDRS combined score (parts I, II and III); several parameters of dyskinesia as assessed by a PD diary including ON time without troublesome dyskinesia, ON time with troublesome dyskinesia, ON time with dyskinesia, OFF time; Clinician's Global Impression of Change in overall PD symptoms including dyskinesia; Fatigue Severity Scale (FSS); and Parkinson's Disease Questionnaire (PDQ-39), a quality of life measure.

  • ADS-5102 significantly reduced the UDysRS Total Objective Score (III, IV), as compared to placebo at both the 340 mg and 420 mg dose levels (p=0.004 and p=0.0004, respectively).
  • A dose response was confirmed using the same statistical model used for the primary efficacy analysis of UDysRS Total Score for the treatment groups in mean change from baseline to week 8 (p<0.01).
  • Treatment with ADS-5102 did not result in clinical worsening of PD, as measured by the MDS-UPDRS combined score (parts I, II, and III).
  • PD diary changes from baseline to week 8 relative to placebo were observed, and for the results for the 340 mg ADS-5102 dose group was are:
    • Decrease in ON time with troublesome dyskinesia of 1.8 hours (p= 0.055)
    • Decrease in ON time with dyskinesia of 2.1 hours (p=0.12)
    • Decrease in OFF time of 0.9 hours (p=0.199)
  • The Clinician's Global Impression of Change demonstrated a statistically significant improvement for the 340 mg dose of ADS-5102, but not statistically significantly improved for either the 260 mg or 420 mg groups.
  • No significant treatment group differences were noted in the Fatigue Severity Scale or the PDQ-39.

The results from the Phase 2/3 study were presented today by Dr. Pahwa during the "Parkinson's Disease: Clinical Trials" session in
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SOURCE Adamas Pharmaceuticals, Inc.
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