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

PHASE2CompletedINTERVENTIONAL
Enrollment

168

Participants

Timeline

Start Date

May 30, 2017

Primary Completion Date

August 22, 2022

Study Completion Date

August 31, 2022

Conditions
Neurobehavioral Disinhibition
Interventions
DRUG

Placebo

Administered as capsules

DRUG

AVP-786-28

28 mg of d6-DM and 4.9 mg of Q

DRUG

AVP-786-42.63

42.63 mg of d6-DM and 4.9 mg of Q

Trial Locations (54)

10016

New York University School of Medicine Site #122, New York

15213

University of Pittsburgh, Pittsburgh

23298

Virginia Commonwealth University #172, Richmond

Virginia Commonwealth University Site#172, Richmond

24153

Salem Research Institute Site# 138, Salem

27713

Carolina Headache Institute, Durham

28144

Salisbury VAMC, Salisbury

28203

Atrium Health - Carolinas Rehabilitation - Charlotte Site #166, Charlotte

28211

New Hope Clinical Research Site#194, Charlotte

29205

WJB Dorn VA-Wm. Jennings Bryan Dorn VA Medical Center, Columbia

32751

Meridien Research, Maitland

33067

Healthcare Innovative Institute, LLC Site# 173, Coral Springs

33122

Premier Clinical Research Institute, Inc., Miami

33125

Project 4 Research, Miami

33155

Allied Biomedical Research Institute, Inc. Site#151, Miami

33166

Science Connections, LLC Site#161, Doral

33172

Design Neuroscience Center, PL, Doral

33458

Alphab Global Research Site#163, Jupiter

33613

USF Dept of Psychiatry and Behavioral Neurosciences Site# 214, Tampa

33634

Meridien Research Site# 108, Tampa

34205

Bradenton Research Center, Inc, Bradenton

34243

Roskamp Institute Clinic, Inc., Sarasota

34972

Health Synergy Clinical Research, Okeechobee

35404

Tuscaloosa Veterans Affairs Medical Center, Tuscaloosa

40475

Baptist Health, Richmond

40536

The University of Kentucky research foundation, Lexington

44130

North Star Medical Research, LLC Site#154, Middleburg Heights

45220

Cincinnati VA Medical Center, Cincinnati

45459

Valley Medical Research, Centerville

48302

Neurobehavioral Medicine Group #222, Bloomfield Hills

63141

Millennium Psychiatric Associates, LLC, Creve Coeur

Clinical Research Professionals, St Louis

65721

Sharlin Health and Neurology, Ozark

73106

IPS Research Site#196, Oklahoma City

75390

University of Texas Southwestern Medical Site#140, Dallas

78229

Polytrauma Rehabilitation Center S. Texas VA Health Care System Site# 146, San Antonio

80209

Mountain View Clinical Research, Inc. Site# 202, Denver

80538

Medical Center of the Rockies, Loveland

80903

Mountain Mind, Colorado Springs

84020

Cedar Clinical Research #221, Draper

85051

Absolute Clinical Research Site#207, Phoenix

85254

Perseverance Research Center Site#152, Scottsdale

90717

Torrance Clinical Research Institute Site#157, Lomita

90822

Tibor Rubin VA Medical Center, SCIRE Biomedical Research Institute, Long Beach

91402

Asclepes Research Centers - Panorama City Site #208, Panorama City

91767

The Neurology Group, Pomona

92037

Kaizen Brain Center #224, La Jolla

92626

ATP Clinical Research Site#150, Costa Mesa

94543

Sunwise Clinical Research, LLC Site#216, Lafayette

96817

Hawaii Pacific Neuroscience Site#184, Honolulu

06416

Connecticut Clinical Research, Cromwell

01103

Sisu BHR Site#200, Springfield

08820

JFK Johnson Rehabilitation Institute, Edison

07856

The NeuroCognitive Insititute, Mount Arlington

All Listed Sponsors
lead

Otsuka Pharmaceutical Development & Commercialization, Inc.

INDUSTRY

NCT03095066 - 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 | Biotech Hunter | Biotech Hunter