drugset / Trial / NCT02740387
Open Label Study of OTO-104 in Subjects With Meniere's Disease
NaSingle-groupOpen-labelTreatment
Summary
This is a 1-year, multicenter, Phase 2, open-label safety study in subjects with unilateral Meniere's disease. Subjects will receive 1 intratympanic (IT) injection of 12 mg OTO-104 at 3-month intervals for a total of 4 injections total.
Timeline
- Start
- 2016-06
- Primary completion
- 2017-09
- Completion
- 2017-09
Outcome
Outcome not reported
Stopped: “Negative Efficacy Results from the recently completed Phase 3 study 104-201506”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dexamethasone | Small molecule | 12 mg | Other |