CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 168 enrolled
Drug / intervention
Placebo +2 moredrug
Likely dose
AVP-786 28 mg d6-DM/4.9 mg Q or 42.63 mg d6-DM/4.9 mg Q (dose comparison study)AI-extracted
Key inclusion· 4
  • ✓History of traumatic brain injury (TBI)
  • ✓Neurobehavioral disinhibition symptoms present after trauma or after recovery of consciousness
  • ✓Score ≥4 on mCGI-S scale AND on Agitation/Aggression or Irritability/Lability subscales of the Neuropsychiatric Inventory (NPI) at screening and baseline
  • ✓Available reliable caregiver
Key exclusion· 2
  • ✕Significant symptoms of major depressive disorder
  • ✕History of or current symptoms of schizophrenia, schizoaffective disorder, bipolar disorder, antisocial personality disorder, or borderline personality disorder

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03095066
NCT03095066Phase 2Completed
CompareCT.gov

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).

Otsuka Pharmaceutical Development & Commercialization, Inc.·interventional·Posted Mar 29, 2017·Updated Oct 29, 2025

In Brief

A Phase 2 clinical trial evaluating Placebo, AVP-786-28, and 1 other intervention for Neurobehavioral Disinhibition. Completed, enrolled 168 participants across 54 sites.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeurobehavioral Disinhibition
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedMar 29, 2017
Enrollment StartMay 30, 2017
Primary CompletionAug 22, 2022
Study CompletionAug 31, 2022
TodayJul 2, 2026
Enrollment to primary: 5.2 yearsPosted 9.3 years ago

Interventions

Placebodrug

Administered as capsules

AVP-786-28drug

28 mg of d6-DM and 4.9 mg of Q

AVP-786-42.63drug

42.63 mg of d6-DM and 4.9 mg of Q