A Randomized, Double Blind, Multicenter, Placebo Controlled, Parallel Group, Efficacy and Safety Study of 2 Doses of Dasotraline in Adults With Attention Deficit Hyperactivity Disorder (ADHD)
Phase of Trial: Phase III
Latest Information Update: 13 Jan 2017
At a glance
- Drugs Dasotraline (Primary)
- Indications Attention-deficit hyperactivity disorder
- Focus Registrational; Therapeutic Use
- Sponsors Sunovion Pharmaceuticals
- 13 Jan 2017 According to a Sunovion Pharmaceuticals Media Release, based on positive data from this trial and discussions with the U.S. FDA, company intends to submit a New Drug Application (NDA) to the FDA in 2017 for ADHD in children and adults.
- 13 Jan 2017 According to a Sunovion Pharmaceuticals Media Release, full results of study SEP360-221 and study SEP360-301 are being analyzed and will be presented at upcoming scientific meetings.
- 13 Jan 2017 Primary endpoint has not been met. (Change from baseline at Week 8 in ADHD symptoms measured by the ADHD Rating Scale Version IV (ADHD RS IV) with adult prompts total score.), as reported in a Sunovion Pharmaceuticals Media Release.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History