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

NCT02446132 ↗

Phase 3 Terminated 1197 enrolled Otsuka Pharmaceutical Development & Commercialization, Inc.

Non-randomizedParallel-groupOpen-labelTreatment

Summary

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

Timeline

Start: 2015-11-13
Primary completion: 2024-09-06
Completion: 2024-09-06

Outcome

Outcome not reported

Stopped (Enrollment): “The AVP-786 program was discontinued, the recruitment was stopped and all participants are no longer being examined or receiving intervention.”

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Deudextromethorphan	Unknown	18 mg	Oral
Subject	Deudextromethorphan	Unknown	28 mg	Oral
Subject	Deudextromethorphan	Unknown	42.63 mg	Oral
Background	Quinidine	Small molecule	4.9 mg	Oral

Indications

No indication recorded.