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ADS-5102 (Amantadine HCl) Extended Release Efficacy and Safety Study in Parkinson's Disease Patients With Levodopa-Induced Dyskinesia (EASE LID 3 Study)

Trial Profile

ADS-5102 (Amantadine HCl) Extended Release Efficacy and Safety Study in Parkinson's Disease Patients With Levodopa-Induced Dyskinesia (EASE LID 3 Study)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 04 Jun 2020

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At a glance

  • Drugs Amantadine (Primary)
  • Indications Drug-induced dyskinesia
  • Focus Registrational; Therapeutic Use
  • Acronyms EASE LID 3
  • Sponsors Adamas Pharmaceuticals
  • Most Recent Events

    • 04 Jun 2020 According to an Adamas Pharmaceuticals media release, a supplemental New Drug Application (sNDA) for GOCOVRI as a treatment for OFF episodes in Parkinson's disease (PD) patients receiving levodopa-based therapy has been accepted for review by the U.S. Food and Drug Administration (FDA). The anticipated Prescription Drug User Fee Act (PDUFA) action date is February 1, 2021.
    • 01 May 2020 Results (n=198) of sub-group analysis from two phase 3 clinical studies: NCT02136914 and NCT02274766 assessing ability of amantadine to reduce disruptive motor episodes (OFF and troublesome dyskinesia) were presented at the 72nd Annual Meeting of the American Academy of Neurology
    • 17 Jun 2019 Results published in the Adamas Pharmaceuticals media release
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