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

Completed · Phase 2 · Has a placebo group

Conditions studied: Neurobehavioral Disinhibition

In brief

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).

Key facts

Study ID

NCT03095066

Run by

Otsuka Pharmaceutical Development & Commercialization, Inc.

People needed

168

Starts

2017-05-30

Expected to finish

2022-08-31

Last updated by the study team

2025-10-29

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Absolute Clinical Research Site#207 — Phoenix, Arizona, United States
• Perseverance Research Center Site#152 — Scottsdale, Arizona, United States
• ATP Clinical Research Site#150 — Costa Mesa, California, United States
• Kaizen Brain Center #224 — La Jolla, California, United States
• Sunwise Clinical Research, LLC Site#216 — Lafayette, California, United States
• Torrance Clinical Research Institute Site#157 — Lomita, California, United States
• Tibor Rubin VA Medical Center, SCIRE Biomedical Research Institute — Long Beach, California, United States
• Asclepes Research Centers - Panorama City Site #208 — Panorama City, California, United States
• The Neurology Group — Pomona, California, United States
• Mountain Mind — Colorado Springs, Colorado, United States
• Mountain View Clinical Research, Inc. Site# 202 — Denver, Colorado, United States
• Medical Center of the Rockies — Loveland, Colorado, United States
• Connecticut Clinical Research — Cromwell, Connecticut, United States
• Bradenton Research Center, Inc — Bradenton, Florida, United States
• Healthcare Innovative Institute, LLC Site# 173 — Coral Springs, Florida, United States
• Science Connections, LLC Site#161 — Doral, Florida, United States
• Design Neuroscience Center, PL — Doral, Florida, United States
• Alphab Global Research Site#163 — Jupiter, Florida, United States
• Meridien Research — Maitland, Florida, United States
• Premier Clinical Research Institute, Inc. — Miami, Florida, United States
• Project 4 Research — Miami, Florida, United States
• Allied Biomedical Research Institute, Inc. Site#151 — Miami, Florida, United States
• Health Synergy Clinical Research — Okeechobee, Florida, United States
• Roskamp Institute Clinic, Inc. — Sarasota, Florida, United States
• Tuscaloosa Veterans Affairs Medical Center — Tuscaloosa, Alabama, United States

Full record on ClinicalTrials.gov

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