drugset / Trial / NCT01934010
AM-101 in the Treatment of Post-Acute Tinnitus 1
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Esketamine | Other / unclassified | — | Other |