Extended Release Amantadine Safety and Efficacy Study in Levodopa-Induced Dyskinesia (EASED Study).
Phase of Trial: Phase II/III
Latest Information Update: 24 Aug 2017
At a glance
- Drugs Amantadine (Primary)
- Indications Drug-induced dyskinesia; Parkinson's disease
- Focus Therapeutic Use
- Acronyms EASED
- Sponsors Adamas Pharmaceuticals
- 24 Aug 2017 According to an Adamas Pharmaceuticals media release, the U.S. Food and Drug Administration (FDA) has approved GOCOVRI (amantadine) extended release capsules for treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications.
- 08 Jan 2017 According to an Adamas Pharmaceuticals media release, the New Drug Application (NDA) is currently under review by the U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) date of August 24, 2017.
- 27 Oct 2016 According to an Adamas Pharmaceuticals media release, based on the data from this and EASE LID, EASE LID 2 and EASE LID 3 the company submitted an NDA of amantadine hydrochloride extended-release capsules to US FDA for the treatment of patients with Parkinsons disease.
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Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History