drugset / Trial / NCT01934010

AM-101 in the Treatment of Post-Acute Tinnitus 1

NCT01934010 ↗

Phase 3 Completed 260 enrolled Auris Medical AG
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this research study is to test the safety and local tolerance of repeated treatment cycles of AM-101.

Timeline

Start
2014-06
Primary completion
2017-01
Completion
2017-01

Outcome

Missed primary endpoint

registry analysis (superiority test); 1 Cycle AM-101 vs 2 Cycles AM-101; p = 0.128; Fisher Exact NCT01934010 ↗

registry analysis (superiority test); 2 Cycles AM-101 vs 3 Cycles AM-101; p = 0.4403; Fisher Exact NCT01934010 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Esketamine Other / unclassified — Other

Indications