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
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.
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).
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT03095066
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 168 participants
Conditions and interventions
Conditions
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 30, 2017 (Actual)
- Primary completion
- Aug 22, 2022 (Actual)
- Completion
- Aug 31, 2022 (Actual)
- Last update posted
- Oct 29, 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 29, 2025 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03095066 live on ClinicalTrials.gov.