NCT03095066

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

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).

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 168 (actual)
• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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).

Detailed description

Eligible participants for this study must have a diagnosis of neurobehavioral disinhibition including aggression, agitation, and irritability that persists after brain injury. This is a multicenter, randomized, placebo-controlled study, consisting of up to 12 weeks of treatment.

Conditions

• Neurobehavioral Disinhibition

Interventions

Type	Name	Description
DRUG	Placebo	Administered as capsules
DRUG	AVP-786-28	28 mg of d6-DM and 4.9 mg of Q
DRUG	AVP-786-42.63	42.63 mg of d6-DM and 4.9 mg of Q

Timeline

• Start date: 2017-05-30
• Primary completion: 2022-08-22
• Completion: 2022-08-31
• First posted: 2017-03-29
• Last updated: 2025-10-29
• Results posted: 2025-10-29

Locations

54 sites across 1 country: United States

Regulatory

• FDA-regulated drug study