ClinicalTrials.gov record
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
ClinicalTrials.gov ID: NCT03095066
Public ClinicalTrials.gov record NCT03095066. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
ClinicalTrials.gov public records Last synced May 20, 2026, 10:19 AM EDT
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 (Deudextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the Treatment of Neurobehavioral Disinhibition Including Aggression, Agitation, and Irritability in Patients With Traumatic Brain Injury (TBI).
Study identification
- NCT ID
- NCT03095066
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Industry
- Enrollment
- 168 participants
Conditions and interventions
Conditions
Interventions
- AVP-786-28 Drug
- AVP-786-42.63 Drug
- Placebo Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 29, 2017
- Primary completion
- Aug 21, 2022
- Completion
- Aug 30, 2022
- Last update posted
- Oct 28, 2025
2017 – 2022
United States locations
- U.S. sites
- 54
- U.S. states
- 21
- U.S. cities
- 48
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Tuscaloosa Veterans Affairs Medical Center | Tuscaloosa | Alabama | 35404 | — |
| Absolute Clinical Research Site#207 | Phoenix | Arizona | 85051 | — |
| Perseverance Research Center Site#152 | Scottsdale | Arizona | 85254 | — |
| ATP Clinical Research Site#150 | Costa Mesa | California | 92626 | — |
| Kaizen Brain Center #224 | La Jolla | California | 92037 | — |
| Sunwise Clinical Research, LLC Site#216 | Lafayette | California | 94543 | — |
| Torrance Clinical Research Institute Site#157 | Lomita | California | 90717 | — |
| Tibor Rubin VA Medical Center, SCIRE Biomedical Research Institute | Long Beach | California | 90822 | — |
| Asclepes Research Centers - Panorama City Site #208 | Panorama City | California | 91402 | — |
| The Neurology Group | Pomona | California | 91767 | — |
| Mountain Mind | Colorado Springs | Colorado | 80903 | — |
| Mountain View Clinical Research, Inc. Site# 202 | Denver | Colorado | 80209 | — |
| Medical Center of the Rockies | Loveland | Colorado | 80538 | — |
| Connecticut Clinical Research | Cromwell | Connecticut | 06416 | — |
| Bradenton Research Center, Inc | Bradenton | Florida | 34205 | — |
| Healthcare Innovative Institute, LLC Site# 173 | Coral Springs | Florida | 33067 | — |
| Science Connections, LLC Site#161 | Doral | Florida | 33166 | — |
| Design Neuroscience Center, PL | Doral | Florida | 33172 | — |
| Alphab Global Research Site#163 | Jupiter | Florida | 33458 | — |
| Meridien Research | Maitland | Florida | 32751 | — |
| Premier Clinical Research Institute, Inc. | Miami | Florida | 33122 | — |
| Project 4 Research | Miami | Florida | 33125 | — |
| Allied Biomedical Research Institute, Inc. Site#151 | Miami | Florida | 33155 | — |
| Health Synergy Clinical Research | Okeechobee | Florida | 34972 | — |
| Roskamp Institute Clinic, Inc. | Sarasota | Florida | 34243 | — |
| USF Dept of Psychiatry and Behavioral Neurosciences Site# 214 | Tampa | Florida | 33613 | — |
| Meridien Research Site# 108 | Tampa | Florida | 33634 | — |
| Hawaii Pacific Neuroscience Site#184 | Honolulu | Hawaii | 96817 | — |
| The University of Kentucky research foundation | Lexington | Kentucky | 40536 | — |
| Baptist Health | Richmond | Kentucky | 40475 | — |
| Sisu BHR Site#200 | Springfield | Massachusetts | 01103 | — |
| Neurobehavioral Medicine Group #222 | Bloomfield Hills | Michigan | 48302 | — |
| Millennium Psychiatric Associates, LLC | Creve Coeur | Missouri | 63141 | — |
| Sharlin Health and Neurology | Ozark | Missouri | 65721 | — |
| Clinical Research Professionals | St Louis | Missouri | 63141 | — |
| JFK Johnson Rehabilitation Institute | Edison | New Jersey | 08820 | — |
| The NeuroCognitive Insititute | Mount Arlington | New Jersey | 07856 | — |
| New York University School of Medicine Site #122 | New York | New York | 10016 | — |
| Atrium Health - Carolinas Rehabilitation - Charlotte Site #166 | Charlotte | North Carolina | 28203 | — |
| New Hope Clinical Research Site#194 | Charlotte | North Carolina | 28211 | — |
| Carolina Headache Institute | Durham | North Carolina | 27713 | — |
| Salisbury VAMC | Salisbury | North Carolina | 28144 | — |
| Valley Medical Research | Centerville | Ohio | 45459 | — |
| Cincinnati VA Medical Center | Cincinnati | Ohio | 45220 | — |
| North Star Medical Research, LLC Site#154 | Middleburg Heights | Ohio | 44130 | — |
| IPS Research Site#196 | Oklahoma City | Oklahoma | 73106 | — |
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | — |
| WJB Dorn VA-Wm. Jennings Bryan Dorn VA Medical Center | Columbia | South Carolina | 29205 | — |
| University of Texas Southwestern Medical Site#140 | Dallas | Texas | 75390 | — |
| Polytrauma Rehabilitation Center S. Texas VA Health Care System Site# 146 | San Antonio | Texas | 78229 | — |
| Cedar Clinical Research #221 | Draper | Utah | 84020 | — |
| Virginia Commonwealth University #172 | Richmond | Virginia | 23298 | — |
| Virginia Commonwealth University Site#172 | Richmond | Virginia | 23298 | — |
| Salem Research Institute Site# 138 | Salem | Virginia | 24153 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03095066, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 28, 2025 · Synced May 20, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03095066 live on ClinicalTrials.gov.