NCT03420222

Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Intermittent Explosive Disorder

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 Intermittent Explosive Disorder (IED)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate AVP-786 for the treatment of Intermittent Explosive Disorder (IED).

Detailed description

Eligible participants for this study must have a diagnosis of current IED. This is a multicenter, randomized, double-blind, placebo-controlled study, consisting of up to 12 weeks of treatment.

Conditions

• Intermittent Explosive Disorder

Interventions

Type	Name	Description
DRUG	AVP-786	oral capsules
DRUG	Placebo	oral capsules

Timeline

• Start date: 2018-01-18
• Primary completion: 2018-12-28
• Completion: 2018-12-28
• First posted: 2018-02-05
• Last updated: 2022-05-24
• Results posted: 2022-05-24

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated drug study