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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)
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
Price :
$35
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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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