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

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.

Inclusion Criteria:

- Participants with traumatic brain injury (TBI)

- Participants with neurobehavioral disinhibition symptoms that are present after trauma
or after recovery of consciousness

- Score of ≥4 on the modified Clinical Global Impression of Severity (mCGI-S) scale and
the Agitation/Aggression or Irritability/Lability subscales of the Neuropsychiatric
Inventory (NPI) scale at screening and baseline

- Participants with a reliable caregiver

Exclusion Criteria:

- Participants with significant symptoms of a major depressive disorder

- Participants with a history of or current clinical symptoms of schizophrenia,
schizoaffective disorder, bipolar disorder, antisocial personality disorder, or
borderline personality disorder