A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 (Deudextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the Treatment of Neurobehavioral Disinhibition Including Aggression, Agitation, and Irritability in Patients With Traumatic Brain Injury (TBI).
Phase of Trial: Phase II
Latest Information Update: 04 Feb 2019
At a glance
- Drugs Deudextromethorphan (Primary)
- Indications Aggression; Agitation; Irritability
- Focus Therapeutic Use
- Sponsors Avanir Pharmaceuticals
- 31 Aug 2018 Biomarkers information updated
- 03 Jan 2018 Planned End Date changed from 1 Dec 2019 to 1 Jun 2020.
- 03 Jan 2018 Planned primary completion date changed from 1 Dec 2019 to 1 Jun 2020.