A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 (Deuterated [d6]-Dextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type
Phase of Trial: Phase III
Latest Information Update: 19 Mar 2018
At a glance
- Drugs Deudextromethorphan (Primary)
- Indications Agitation
- Focus Registrational; Therapeutic Use
- Acronyms TRIAD-1
- Sponsors Avanir Pharmaceuticals
- 03 Jan 2018 Planned End Date changed from 1 Jul 2018 to 1 Apr 2019.
- 03 Jan 2018 Planned primary completion date changed from 1 Jul 2018 to 1 Apr 2019.
- 17 Nov 2015 According to an Otsuka Pharmaceutical media release, this clinical trial has been granted "Fast Track" status (priority approval system) by the U.S. Food and Drug Administration.