drugset / Trial / NCT03471767

AXS-05 Phase II Trial on Smoking Behavior

NCT03471767 ↗

Phase 2 Completed 58 enrolled James Davis Axsome Therapeutics, Inc. · collab
RandomizedParallel-groupDouble-blindTreatment

Summary

This research study is designed with the purpose of evaluating a new drug, combination Dextromethorphan-Bupropion (AXS-05), for its effects on smoking behavior.

Timeline

Start
2018-03-25
Primary completion
2019-03-31
Completion
2019-03-31

Outcome

Missed primary endpoint

registry analysis (other test); AXS-05 vs Bupropion SR; p = 0.15; t-test, 2 sided NCT03471767 ↗

Drugs

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

Indications