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
NCT ID: NCT03095066
Last Updated: 2025-10-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
168 participants
INTERVENTIONAL
2017-05-30
2022-08-31
Brief Summary
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Detailed Description
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This is a multicenter, randomized, placebo-controlled study, consisting of up to 12 weeks of treatment.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Stage 1: Placebo Non-responders to Stage 2: Placebo
Participants who were randomized to receive placebo in Stage 1 and were classified as non-responders (responders" if modified Clinical Global Impression of Severity \[mCGI-S\] score is ≤ 3 at Day 43 and NPI-C-3 score has decreased by ≥ 25% from baseline. Participants who did not meet these criteria were considered "non-responders) after Week 6 were re-randomized to continue receiving AVP-786 matching placebo capsules, orally, BID during Weeks 7 to 12 of the Stage 2 treatment period.
Placebo
Administered as capsules
Overall Study: Stage 1 Placebo/Stage 2 Placebo or Stage 1 Placebo/Stage 2 AVP-786
Participants received AVP-786 matching placebo capsules, orally, twice daily (BID) during Weeks 1 to 6 of the Stage 1 treatment period. After Week 6 participants were classified as responders or non-responders and were re-randomized to receive either placebo, orally, BID or AVP-786 in a dose escalation schedule to reach the target dose of AVP-786-42.63/4.9, orally, BID during Week 7 to Week 12 of Stage 1 treatment period.
Placebo
Administered as capsules
AVP-786-42.63
42.63 mg of d6-DM and 4.9 mg of Q
Overall Study: Stage 1 AVP-786/Stage 2 AVP-786
Participants received AVP-786-28/4.9 (deudextromethorphan hydrobromide (d6-DM) 28 milligrams (mg)/quinidine sulfate (Q) 4.9 mg) capsule, along with AVP-786 matching placebo capsule, orally, once daily (QD) during Week 1 followed by AVP-786-28/4.9 capsule, orally, BID during Week 2, and AVP-786-42.63/4.9 (d6-DM 42.63 mg/Q 4.9 mg) capsules (target dose), orally, BID during Weeks 3 to 12 of the treatment period.
Placebo
Administered as capsules
AVP-786-28
28 mg of d6-DM and 4.9 mg of Q
AVP-786-42.63
42.63 mg of d6-DM and 4.9 mg of Q
Stage 1: Placebo
Participants received AVP-786 matching placebo capsules, orally, BID during Weeks 1 to 6 of the Stage 1 treatment period.
Placebo
Administered as capsules
Stage 1: Placebo Non-responders to Stage 2: AVP-786
Participants who received placebo in Stage 1 and were classified as non-responders (responders" if mCGI-S score is ≤ 3 at Day 43 and NPI-C-3 score has decreased by ≥ 25% from baseline. Participants who did not meet these criteria were considered "non-responders) after Week 6 were re-randomized to receive AVP-786 in Stage 2 using the same dose escalation schedule used in Stage 1 i.e., AVP-786-28- 28/4.9 capsule, along with AVP-786 matching placebo capsule, orally, QD during Week 7 followed by AVP-786-28 -28/4.9 capsule, orally, BID during Week 8, and AVP-786-42.63/4.9 capsules, orally, BID during Weeks 9 to 12 of the Stage 2 treatment period.
Placebo
Administered as capsules
AVP-786-28
28 mg of d6-DM and 4.9 mg of Q
AVP-786-42.63
42.63 mg of d6-DM and 4.9 mg of Q
Stage 1: Placebo Responders to Stage 2: Placebo
Participants who were randomized to receive placebo in Stage 1 and were classified as responders (responders" if mCGI-S score is ≤ 3 at Day 43 and NPI-C-3 score has decreased by ≥ 25% from baseline) after Week 6 were re-randomized to continue receiving AVP-786 matching placebo capsules, orally, BID during Weeks 7 to 12 of the Stage 2 treatment period.
Placebo
Administered as capsules
Stage 1: Placebo Responders to Stage 2: AVP-786
Participants who received placebo in Stage 1 and were classified as responders (responders" if mCGI-S score is ≤ 3 at Day 43 and NPI-C-3 score has decreased by ≥ 25% from baseline) after Week 6 were re-randomized to receive AVP-786 in Stage 2 using the same dose escalation schedule used in Stage 1 i.e., AVP-786-28- 28/4.9 capsule, along with AVP-786 matching placebo capsule, orally, QD during Week 7 followed by AVP-786-28 -28/4.9 capsule, orally, BID during Week 8, and AVP-786-42.63/4.9 capsules, orally, BID during Weeks 9 to 12 of the Stage 2 treatment period.
Placebo
Administered as capsules
AVP-786-28
28 mg of d6-DM and 4.9 mg of Q
AVP-786-42.63
42.63 mg of d6-DM and 4.9 mg of Q
Stage 1: AVP-786
Participants received AVP-786-28/4.9 (deudextromethorphan hydrobromide (d6-DM) 28 milligrams (mg)/quinidine sulfate (Q) 4.9 mg) capsule, along with AVP-786 matching placebo capsule, orally, once daily (QD) during Week 1 followed by AVP-786-28/4.9 capsule, orally, BID during Week 2, and AVP-786-42.63/4.9 (d6-DM 42.63 mg/Q 4.9 mg) capsules (target dose), orally, BID during Weeks 3 to 6 of the Stage 1 treatment period.
Placebo
Administered as capsules
AVP-786-28
28 mg of d6-DM and 4.9 mg of Q
AVP-786-42.63
42.63 mg of d6-DM and 4.9 mg of Q
Interventions
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Placebo
Administered as capsules
AVP-786-28
28 mg of d6-DM and 4.9 mg of Q
AVP-786-42.63
42.63 mg of d6-DM and 4.9 mg of Q
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Participants with a history of or current clinical symptoms of schizophrenia, schizoaffective disorder, bipolar disorder, antisocial personality disorder, or borderline personality disorder
18 Years
75 Years
ALL
No
Sponsors
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Otsuka Pharmaceutical Development & Commercialization, Inc.
INDUSTRY
Responsible Party
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Locations
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Tuscaloosa Veterans Affairs Medical Center
Tuscaloosa, Alabama, United States
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
USF Dept of Psychiatry and Behavioral Neurosciences Site# 214
Tampa, Florida, United States
Meridien Research Site# 108
Tampa, Florida, United States
Hawaii Pacific Neuroscience Site#184
Honolulu, Hawaii, United States
The University of Kentucky research foundation
Lexington, Kentucky, United States
Baptist Health
Richmond, Kentucky, United States
Sisu BHR Site#200
Springfield, Massachusetts, United States
Neurobehavioral Medicine Group #222
Bloomfield Hills, Michigan, United States
Millennium Psychiatric Associates, LLC
Creve Coeur, Missouri, United States
Sharlin Health and Neurology
Ozark, Missouri, United States
Clinical Research Professionals
St Louis, Missouri, United States
JFK Johnson Rehabilitation Institute
Edison, New Jersey, United States
The NeuroCognitive Insititute
Mount Arlington, New Jersey, United States
New York University School of Medicine Site #122
New York, New York, United States
Atrium Health - Carolinas Rehabilitation - Charlotte Site #166
Charlotte, North Carolina, United States
New Hope Clinical Research Site#194
Charlotte, North Carolina, United States
Carolina Headache Institute
Durham, North Carolina, United States
Salisbury VAMC
Salisbury, North Carolina, United States
Valley Medical Research
Centerville, Ohio, United States
Cincinnati VA Medical Center
Cincinnati, Ohio, United States
North Star Medical Research, LLC Site#154
Middleburg Heights, Ohio, United States
IPS Research Site#196
Oklahoma City, Oklahoma, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
WJB Dorn VA-Wm. Jennings Bryan Dorn VA Medical Center
Columbia, South Carolina, United States
University of Texas Southwestern Medical Site#140
Dallas, Texas, United States
Polytrauma Rehabilitation Center S. Texas VA Health Care System Site# 146
San Antonio, Texas, United States
Cedar Clinical Research #221
Draper, Utah, United States
Virginia Commonwealth University #172
Richmond, Virginia, United States
Virginia Commonwealth University Site#172
Richmond, Virginia, United States
Salem Research Institute Site# 138
Salem, Virginia, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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17-AVP-786-205
Identifier Type: -
Identifier Source: org_study_id
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