Phase 2
N=168
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
Neurobehavioral Disinhibition
Bottom Line
View on ClinicalTrials.gov: NCT03095066 ↗Enrolled (actual)
168
Serious AEs
1.5%
Results posted
Oct 2025
Primary outcome: Primary: Stage 1: Change From Baseline in the Composite of the Clinical Impression Severity Scores on the Neuropsychiatric Inventory Clinician Rating Scale (NPI-C) Subscale of Aggression, Agitation, and Irritability/Lability (NPI-C-3) — -18.7; -20.4 score on a scale — p=0.405
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Placebo (Drug); AVP-786-28 (Drug); AVP-786-42.63 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Primary completion
- Aug 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Stage 1: Change From Baseline in the Composite of the Clinical Impression Severity Scores on the Neuropsychiatric Inventory Clinician Rating Scale (NPI-C) Subscale of Aggression, Agitation, and Irritability/Lability (NPI-C-3) |
-18.7; -20.4 | 0.405 |
| PRIMARY Stage 2: Change From Baseline in the Composite of the Clinical Impression Severity Scores on the NPI-C Subscale of NPI-C-3 |
-5.2; -5.9 | 0.921 |
| SECONDARY Stage 1 and Stage 2: Change From Baseline in NPI-C Rating Scale Subscale Scores for Aggression |
-3.6; -4.3; -0.8; -0.6 | 0.150 |
| SECONDARY Stage 1 and Stage 2: Change From Baseline in NPI-C Rating Scale Subscale Scores for Agitation |
-7.0; -6.7; -2.6; -0.6 | 0.702 |
| SECONDARY Stage 1 and Stage 2: Change From Baseline in NPI-C Rating Scale Subscale Scores for Irritability/Lability |
-8.5; -9.7; -3.1; -4.7 | 0.267 |
| SECONDARY Stage 1 and Stage 2: Change From Baseline in NPI-C Rating Scale Subscale Scores for Disinhibition |
-5.1; -5.4; -3.6; -2.4 | 0.743 |
| SECONDARY Stage 1 and Stage 2: Change From Baseline in Modified Clinical Global Impression of Severity (mCGI-S) Scale Scores |
-1.2; -1.3; -0.5; -1.1 | 0.664 |
| SECONDARY Stage 1 and Stage 2: Change From Baseline in Patient Global Impression of Severity (PGI-S) Scores |
-1.1; -1.4; 0.0; -0.2 | 0.159 |
| SECONDARY Stage 1 and Stage 2: Modified Clinical Global Impression of Change (mCGI-C) Raw Scores |
2.7; 2.5; 3.0; 2.5 | 0.268 |
| SECONDARY Stage 1 and Stage 2: Patient Global Impression of Change (PGI-C) Raw Scores |
2.7; 2.4; 2.9; 2.6 | 0.655 |
Summary
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).
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03095066). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.