Neurobehavioral Disinhibition Clinical Trial
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).
| Verified date | September 2023 |
| Source | Otsuka Pharmaceutical Development & Commercialization, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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).
| Status | Completed |
| Enrollment | 168 |
| Est. completion date | August 31, 2022 |
| Est. primary completion date | August 22, 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 75 Years |
| Eligibility | Inclusion Criteria: - Participants with TBI - 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 significant symptoms of a major depressive disorder - Participants with a history of or current clinical symptoms of schizophrenia, schizoaffective disorder, bipolar disorder, antisocial personality disorder, or borderline personality disorder |
| Country | Name | City | State |
|---|---|---|---|
| United States | Neurobehavioral Medicine Group #222 | Bloomfield Hills | Michigan |
| United States | Bradenton Research Center, Inc | Bradenton | Florida |
| United States | Valley Medical Research | Centerville | Ohio |
| 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 | Cincinnati VA Medical Center | Cincinnati | Ohio |
| United States | Mountain Mind | Colorado Springs | Colorado |
| United States | WJB Dorn VA-Wm. Jennings Bryan Dorn VA Medical Center | Columbia | South Carolina |
| United States | Healthcare Innovative Institute, LLC Site# 173 | Coral Springs | Florida |
| United States | ATP Clinical Research Site#150 | Costa Mesa | California |
| United States | Millennium Psychiatric Associates, LLC | Creve Coeur | Missouri |
| United States | Connecticut Clinical Research | Cromwell | Connecticut |
| United States | University of Texas Southwestern Medical Site#140 | Dallas | Texas |
| United States | Mountain View Clinical Research, Inc. Site# 202 | Denver | Colorado |
| United States | Design Neuroscience Center, PL | Doral | Florida |
| United States | Science Connections, LLC Site#161 | Doral | Florida |
| United States | Cedar Clinical Research #221 | Draper | Utah |
| United States | Carolina Headache Institute | Durham | North Carolina |
| United States | JFK Johnson Rehabilitation Institute | Edison | New Jersey |
| United States | Hawaii Pacific Neuroscience Site#184 | Honolulu | Hawaii |
| United States | Alphab Global Research Site#163 | Jupiter | Florida |
| United States | Kaizen Brain Center #224 | La Jolla | California |
| United States | Sunwise Clinical Research, LLC Site#216 | Lafayette | California |
| United States | The University of Kentucky research foundation | Lexington | Kentucky |
| 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 | Medical Center of the Rockies | Loveland | Colorado |
| United States | Meridien Research | Maitland | Florida |
| United States | Allied Biomedical Research Institute, Inc. Site#151 | Miami | Florida |
| United States | Premier Clinical Research Institute, Inc. | Miami | Florida |
| United States | Project 4 Research | Miami | Florida |
| United States | North Star Medical Research, LLC Site#154 | Middleburg Heights | Ohio |
| 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 | Health Synergy Clinical Research | Okeechobee | Florida |
| United States | IPS Research Site#196 | Oklahoma City | Oklahoma |
| United States | Sharlin Health and Neurology | Ozark | Missouri |
| United States | Asclepes Research Centers - Panorama City Site #208 | Panorama City | California |
| United States | Absolute Clinical Research Site#207 | Phoenix | Arizona |
| United States | University of Pittsburgh | Pittsburgh | Pennsylvania |
| United States | The Neurology Group | Pomona | California |
| United States | Baptist Health | Richmond | Kentucky |
| United States | Virginia Commonwealth University #172 | Richmond | Virginia |
| United States | Virginia Commonwealth University Site#172 | Richmond | Virginia |
| United States | Clinical Research Professionals | Saint Louis | Missouri |
| United States | Salem Research Institute Site# 138 | Salem | Virginia |
| United States | Salisbury VAMC | Salisbury | North Carolina |
| United States | Polytrauma Rehabilitation Center S. Texas VA Health Care System Site# 146 | San Antonio | Texas |
| United States | Roskamp Institute Clinic, Inc. | Sarasota | Florida |
| United States | Perseverance Research Center Site#152 | Scottsdale | Arizona |
| United States | Sisu BHR Site#200 | Springfield | Massachusetts |
| United States | Meridien Research Site# 108 | Tampa | Florida |
| United States | USF Dept of Psychiatry and Behavioral Neurosciences Site# 214 | Tampa | Florida |
| United States | Tuscaloosa Veterans Affairs Medical Center | Tuscaloosa | Alabama |
| Lead Sponsor | Collaborator |
|---|---|
| Otsuka Pharmaceutical Development & Commercialization, Inc. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change from Baseline to Week 12 in the Composite of the Clinical Impression Severity Scores on the Neuropsychiatric Inventory Clinician Rating Scale (NPI-C) Subscales of Aggression, Agitation, and Irritability/Lability (NPI-C-3) | The NPI-C can be used to rate the presence of neuropsychiatric symptoms across 14 domains. The scores for each item within an individual domain/subscale range from 0 to 3, with a higher score indicating increased severity. The NPI-C-3 is comprised of the aggression, agitation, and irritability/lability subscales. The scores for the three subscales are summed to create the total NPI-C-3 composite score, which ranges from 0 to 99, with a higher score indicating increased severity. | Baseline; Week 12 | |
| Secondary | Change from Baseline to Week 12 in Modified Clinical Global Impression of Change (mCGI-C) Raw Scores | The mCGI-C will be used to assess the clinician's general impression of the participant's treatment response. The mCGI-C is a 7-point (1 to 7) modified version of the CGI-C scale. A higher score represents worsening of symptoms. | Baseline; Week 12 | |
| Secondary | Change from Baseline to Week 12 in NPI-C Rating Scale Subscales Scores for Aggression, Agitation, Irritability/Lability, and Disinhibition | The NPI-C is used to rate the presence of neuropsychiatric symptoms across 14 domains. The scores for each item within an individual domain/subscale range from 0 to 3, with a higher score indicating increased severity. | Baseline; Week 12 | |
| Secondary | Change from Baseline to Week 12 in Modified Clinical Global Impression of Severity (mCGI-S) Scale Scores | The mCGI-S will be used to assess the clinician's view of the participant's severity of aggression, agitation, and irritability symptoms. The mCGI-S is a 7-point (1 to 7) modified version of the CGI-S scale. In all cases, a higher score represents increased severity. | Baseline; Week 12 | |
| Secondary | Change from Baseline to Week 12 in Patient Global Impression of Severity (PGI-S) Scores | The PGI-S is a single-question scale that specifically assesses the severity of symptoms of neurobehavioral disinhibition, including aggression, agitation, and irritability, on a 7-point scale : 1, normal, not at all ill; 2, borderline ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill. | Baseline; Week 12 | |
| Secondary | Change from Baseline to Week 12 in Patient Global Impression of Change (PGI-C) Raw Scores | The PGI-C is a 7-point (1 to 7) scale used to assess the participant's assessment of treatment response. A higher score indicates worsening of the symptoms. | Baseline; Week 12 |