drugset / Trial / NCT04947553

A Study to Assess the Long-term Safety and Efficacy of AXS-05 in Subjects With Alzheimer's Disease Agitation

NCT04947553 ↗

Phase 3 Completed 456 enrolled Axsome Therapeutics, Inc.
RandomizedParallel-groupTriple-blindTreatment

Summary

This study will evaluate the long-term safety and efficacy of AXS-05 in subjects with Alzheimer's disease (AD) agitation.

Timeline

Start
2021-06-17
Primary completion
2024-12-03
Completion
2024-12-21

Outcome

Met primary endpoint

release “The ACCORD-2 Phase 3 trial achieved the primary endpoint with AXS-05 statistically significantly delaying the time to relapse of agitation” gcs-web.com ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Bupropion Small molecule — —
Subject Dextromethorphan Unknown — —

Indications