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New drug calms brain injury rage in early trial

NCT ID NCT03095066

Symptom relief Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested an experimental drug called AVP-786 in 168 people with traumatic brain injury who had symptoms like aggression, agitation, and irritability. The goal was to see if the drug could safely reduce these difficult behaviors. Participants received either the drug or a placebo, and researchers measured changes in their symptoms over time.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

168 people

The number who actually took part.

Started

May 2017

Finished

Aug 2022

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Participants with TBI * Participants with neurobehavioral disinhibition symptoms that are present after trauma or after recovery of consciousness * Score of ≥4 on the 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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Conditions

The condition(s) this trial relates to.

Aggression Brain Injuries, Traumatic Psychomotor Agitation traumatic brain injury

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Neurobehavioral disinhibition

Contacts and locations

Locations

  • ATP Clinical Research Site#150

    Costa Mesa, California, 92626, United States

  • Absolute Clinical Research Site#207

    Phoenix, Arizona, 85051, United States

  • Allied Biomedical Research Institute, Inc. Site#151

    Miami, Florida, 33155, United States

  • Alphab Global Research Site#163

    Jupiter, Florida, 33458, United States

  • Asclepes Research Centers - Panorama City Site #208

    Panorama City, California, 91402, United States

  • Atrium Health - Carolinas Rehabilitation - Charlotte Site #166

    Charlotte, North Carolina, 28203, United States

  • Baptist Health

    Richmond, Kentucky, 40475, United States

  • Bradenton Research Center, Inc

    Bradenton, Florida, 34205, United States

  • Carolina Headache Institute

    Durham, North Carolina, 27713, United States

  • Cedar Clinical Research #221

    Draper, Utah, 84020, United States

  • Cincinnati VA Medical Center

    Cincinnati, Ohio, 45220, United States

  • Clinical Research Professionals

    St Louis, Missouri, 63141, United States

  • Connecticut Clinical Research

    Cromwell, Connecticut, 06416, United States

  • Design Neuroscience Center, PL

    Doral, Florida, 33172, United States

  • Hawaii Pacific Neuroscience Site#184

    Honolulu, Hawaii, 96817, United States

  • Health Synergy Clinical Research

    Okeechobee, Florida, 34972, United States

  • Healthcare Innovative Institute, LLC Site# 173

    Coral Springs, Florida, 33067, United States

  • IPS Research Site#196

    Oklahoma City, Oklahoma, 73106, United States

  • JFK Johnson Rehabilitation Institute

    Edison, New Jersey, 08820, United States

  • Kaizen Brain Center #224

    La Jolla, California, 92037, United States

  • Medical Center of the Rockies

    Loveland, Colorado, 80538, United States

  • Meridien Research

    Maitland, Florida, 32751, United States

  • Meridien Research Site# 108

    Tampa, Florida, 33634, United States

  • Millennium Psychiatric Associates, LLC

    Creve Coeur, Missouri, 63141, United States

  • Mountain Mind

    Colorado Springs, Colorado, 80903, United States

  • Mountain View Clinical Research, Inc. Site# 202

    Denver, Colorado, 80209, United States

  • Neurobehavioral Medicine Group #222

    Bloomfield Hills, Michigan, 48302, United States

  • New Hope Clinical Research Site#194

    Charlotte, North Carolina, 28211, United States

  • New York University School of Medicine Site #122

    New York, New York, 10016, United States

  • North Star Medical Research, LLC Site#154

    Middleburg Heights, Ohio, 44130, United States

  • Perseverance Research Center Site#152

    Scottsdale, Arizona, 85254, United States

  • Polytrauma Rehabilitation Center S. Texas VA Health Care System Site# 146

    San Antonio, Texas, 78229, United States

  • Premier Clinical Research Institute, Inc.

    Miami, Florida, 33122, United States

  • Project 4 Research

    Miami, Florida, 33125, United States

  • Roskamp Institute Clinic, Inc.

    Sarasota, Florida, 34243, United States

  • Salem Research Institute Site# 138

    Salem, Virginia, 24153, United States

  • Salisbury VAMC

    Salisbury, North Carolina, 28144, United States

  • Science Connections, LLC Site#161

    Doral, Florida, 33166, United States

  • Sharlin Health and Neurology

    Ozark, Missouri, 65721, United States

  • Sisu BHR Site#200

    Springfield, Massachusetts, 01103, United States

  • Sunwise Clinical Research, LLC Site#216

    Lafayette, California, 94543, United States

  • The NeuroCognitive Insititute

    Mount Arlington, New Jersey, 07856, United States

  • The Neurology Group

    Pomona, California, 91767, United States

  • The University of Kentucky research foundation

    Lexington, Kentucky, 40536, United States

  • Tibor Rubin VA Medical Center, SCIRE Biomedical Research Institute

    Long Beach, California, 90822, United States

  • Torrance Clinical Research Institute Site#157

    Lomita, California, 90717, United States

  • Tuscaloosa Veterans Affairs Medical Center

    Tuscaloosa, Alabama, 35404, United States

  • USF Dept of Psychiatry and Behavioral Neurosciences Site# 214

    Tampa, Florida, 33613, United States

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15213, United States

  • University of Texas Southwestern Medical Site#140

    Dallas, Texas, 75390, United States

  • Valley Medical Research

    Centerville, Ohio, 45459, United States

  • Virginia Commonwealth University #172

    Richmond, Virginia, 23298, United States

  • Virginia Commonwealth University Site#172

    Richmond, Virginia, 23298, United States

  • WJB Dorn VA-Wm. Jennings Bryan Dorn VA Medical Center

    Columbia, South Carolina, 29205, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.