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

Study Identifier:

17-AVP-786-205

ClinicalTrials.gov Identifier:

NCT03095066

EudraCT Identifier:

N/A

Sponsor:

Otsuka Pharmaceutical Development & Commercialization, Inc.

Study Contact Information:

N/A

Study Complete

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Study Details

Medical Condition

Neurobehavioral Disinhibition

Study Drug

Drug: Placebo
Drug: AVP-786-28
Drug: AVP-786-42.63

Date

May 2017 - Aug 2022

Phase 1

Phase 2

Phase 3

Phase 4

N/A

Patient Requirements

Sex: Female & Male

Age: 18 - 75 Years

Requirements Information

Protocol 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).

Study Locations

Location

Status

Location

Tuscaloosa Veterans Affairs Medical Center

Tuscaloosa, Alabama, United States, 35404

Status

N/A

Location

Absolute Clinical Research Site#207

Phoenix, Arizona, United States, 85051

Status

N/A

Location

Perseverance Research Center Site#152

Scottsdale, Arizona, United States, 85254

Status

N/A

Location

ATP Clinical Research Site#150

Costa Mesa, California, United States, 92626

Status

N/A

Location

Kaizen Brain Center #224

La Jolla, California, United States, 92037

Status

N/A

Location

Sunwise Clinical Research, LLC Site#216

Lafayette, California, United States, 94543

Status

N/A