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

  • End date
    Oct 11, 2022
  • participants needed
  • sponsor
    Otsuka Pharmaceutical Development & Commercialization, Inc.
Updated on 11 May 2022


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).


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.

Condition Neurobehavioral Disinhibition
Treatment Placebo, AVP-786
Clinical Study IdentifierNCT03095066
SponsorOtsuka Pharmaceutical Development & Commercialization, Inc.
Last Modified on11 May 2022


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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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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