NCT03393520

Assessment of the Efficacy, Safety, and Tolerability of AVP-786 (Deudextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-design Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 (Deudextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 601 (actual)
• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. · Industry
• Sex: All
• Age: 50 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

This study will be conducted to evaluate the efficacy, safety, and tolerability of AVP-786 compared to placebo, for the treatment of agitation in participants with dementia of the Alzheimer's type.

Detailed description

Eligible participants for this study must have a diagnosis of probable Alzheimer's disease (AD) and must have clinically significant, moderate/severe agitation secondary to AD. This is a multicenter, randomized, double-blind, placebo-controlled, parallel-design study, consisting of 12 weeks of treatment. Approximately 550 participants will be enrolled at approximately 90 centers worldwide. Study medication will be administered orally twice-daily from Day 1 through Day 85. Screening will occur within approximately 4 weeks prior to randomization. Following screening procedures for assessment of inclusion and exclusion criteria, eligible participants will be randomized into the study.

Conditions

• Agitation in Patients With Dementia of the Alzheimer's Type

Interventions

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

Timeline

• Start date: 2017-10-13
• Primary completion: 2023-11-17
• Completion: 2023-12-14
• First posted: 2018-01-08
• Last updated: 2024-11-20

Locations

211 sites across 11 countries: United States, Australia, Bulgaria, Czechia, France, Hungary, Italy, Poland, South Africa, Spain, United Kingdom

Regulatory

• FDA-regulated drug study