NCT02446132

Long Term, Extension Study of the Safety and Efficacy of AVP-786 for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type

A Phase 3, Multicenter, Long Term, Extension Study of the Safety and Efficacy of AVP-786 (Deuterated [d6] Dextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,197 (actual)
• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. · Industry
• Sex: All
• Age: 50 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

This was an extension study of the Phase 3 Studies 15-AVP-786-301, 15-AVP-786-302, and 17-AVP-786-305.

Detailed description

Eligible participants for this study had successfully completed Studies 15-AVP-786-301, 15-AVP-786-302, 12-AVR-131, or 17-AVP-786-305. Study medication was administered orally twice daily.

Conditions

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

Interventions

Type	Name	Description
DRUG	AVP-786

Timeline

• Start date: 2015-11-13
• Primary completion: 2024-09-06
• Completion: 2024-09-06
• First posted: 2015-05-18
• Last updated: 2025-10-15
• Results posted: 2025-10-15

Locations

227 sites across 10 countries: United States, Bulgaria, Canada, Czechia, France, Hungary, Italy, Poland, South Africa, Spain

Regulatory

• FDA-regulated drug study