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Clinical Trial 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).


Clinical Trial Description

Eligible participants for this study must have a diagnosis of neurobehavioral disinhibition including aggression, agitation, and irritability that persists after brain injury. This is a multicenter, randomized, placebo-controlled study, consisting of up to 12 weeks of treatment. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03095066
Study type Interventional
Source Otsuka Pharmaceutical Development & Commercialization, Inc.
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Status Completed
Phase Phase 2
Start date May 30, 2017
Completion date August 31, 2022