Extended Release Amantadine Safety and Efficacy Study in Levodopa-Induced Dyskinesia (EASED Study).
Phase of Trial: Phase II/III
Latest Information Update: 20 Feb 2017
At a glance
- Drugs Amantadine (Primary)
- Indications Drug-induced dyskinesia; Parkinson's disease
- Focus Therapeutic Use
- Acronyms EASED
- Sponsors Adamas Pharmaceuticals
- 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.
- 28 Apr 2016 According to an Adamas Pharmaceuticals media release, the company expects to submit an NDA in 2016 and, assuming FDA approval, launch the product in 2017.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History