Phase 3
Completed N=166
Study of OTO-104 in Subjects With Unilateral Meniere's Disease
Source: ClinicalTrials.gov NCT02612337 ↗Enrolled (actual)
166
Serious AEs
2.4%
Results posted
Jan 2023
Primary outcomePrimary: The Number of DVD at Week 12 (Defined as the 4-week [28 Days] Interval From Week 9 Through Week 12). — 2.191; 2.415 Definitive Vertigo Day — p=0.623
◆ Published Evidence
Emerging
16citations · ~5 / year
Efficacy of Intratympanic OTO-104 for the Treatment of Ménière's Disease: The Outcome of Three Randomized, Double-Blind, Placebo-Controlled Studies.
Summary
The purpose of this study is to evaluate the effectiveness of OTO-104 for the treatment of Meniere's disease.
Linked Publications
-
Efficacy of Intratympanic OTO-104 for the Treatment of Ménière's Disease: The Outcome of Three Randomized, Double-Blind, Placebo-Controlled Studies.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Number of DVD at Week 12 (Defined as the 4-week [28 Days] Interval From Week 9 Through Week 12). |
2.191; 2.415 | 0.623 |
| SECONDARY Effect of Vertigo on Daily Activities - Number of Days Sick at Home or Bedridden at Week 12 (Month 3) |
1.287; 1.058 | — |
| SECONDARY Otoscopic Examination - Tympanic Membrane Perforation at Week 12 (Month 3) |
4; 0 | — |
| SECONDARY Audiometry - Shift in Air-Bone Gap at 500 Hz From Baseline to Week 12 (Month 3) |
2; 7 | — |
| SECONDARY Audiometry - Shift in Air-Bone Gap at 1000 Hz From Baseline to Week 12 (Month 3) |
3; 3 | — |
| SECONDARY Audiometry - Shift in Air-Bone Gap at 2000 Hz From Baseline to Week 12 (Month 3) |
4; 1 | — |
Eligibility Criteria
Inclusion Criteria includes, but is not limited to:
- Subject has a diagnosis of unilateral Meniere's disease by 1995 American Academy of Otolaryngology - Head and Neck Surgery (AAOHNS) criteria and reports active vertigo for the 2 months prior to the study lead-in period.
- Subject has experienced active vertigo during the lead-in period.
- Subject has documented asymmetric sensorineural hearing loss.
- Subject agrees to maintain their current treatments for Meniere's disease while on-study.
Exclusion Criteria includes, but is not limited to:
- Subject is pregnant or lactating.
- Subject has a history of immunodeficiency disease.
- Subject has a history of previous endolymphatic sac surgery.
- Subject has a history of previous use of intratympanic (IT) gentamicin in the affected ear.
- Subject has a history of tympanostomy tubes with evidence of perforation or lack of closure.
- Subject has experienced an adverse reaction to IT injection of steroids.
- Subject has used an investigational drug or device in the 3 months prior to screening.
- Subject has previously been randomized to a trial of OTO-104.
Data sourced from ClinicalTrials.gov (NCT02612337) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.