drugset
drugset / Trial / NCT02442765

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

NCT02442765 ↗

Phase 3 Completed 387 enrolled Otsuka Pharmaceutical Development & Commercialization, Inc.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Participants with agitation secondary to dementia of the Alzheimer's type. The diagnosis of probable Alzheimer's disease (AD) was to be based on the "2011 Diagnostic Guidelines for Alzheimer's Disease" issued by the National Institute on Aging (NIA)-Alzheimer's Association (AA) workgroups.

Timeline

Start
2015-07-23
Primary completion
2019-01-30
Completion
2019-02-27

Drugs

EvaluationDrugModalityDoseRoute
Subject Deudextromethorphan Unknown 18 mg Oral
Subject Deudextromethorphan Unknown 28 mg Oral
Subject Quinidine Small molecule 4.9 mg Oral

Indications

No indication recorded.