Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Neurobehavioral Disinhibition Including Aggression, Agitation, and Irritability in Participants With Traumatic Brain Injury

Summary

This is a multicenter, randomized, placebo-controlled study to evaluate AVP-786 for the treatment of neurobehavioral disinhibition including aggression, agitation, and irritability in participants with traumatic brain injury (TBI).

Timeline

Start

2017-05-30

Primary completion

2022-08-22

Completion

2022-08-31

Outcome

Missed primary endpoint

registry Stage 1: Placebo vs Stage 1: AVP-786; p = 0.405; Difference in LS Mean -1.7 (95% CI -5.8 to 2.4) NCT03095066 ↗

registry Stage 1: Placebo Non-responders to Stage 2: Placebo vs Stage 1: Placebo Non-responders to Stage 2: AVP-786; p = 0.921; Difference in LS Mean -0.7 (95% CI -15.3 to 13.9) NCT03095066 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	AVP-786	Unknown	42.63 mg	Oral

Indications