Phase 3
N=166
Study of OTO-104 in Subjects With Unilateral Meniere's Disease
Meniere's Disease
Bottom Line
View on ClinicalTrials.gov: NCT02612337 ↗Enrolled (actual)
166
Serious AEs
2.4%
Results posted
Jan 2023
Primary outcome: 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 Definitive Vertigo Day — p=0.623
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- OTO-104 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Otonomy, Inc.
- Primary completion
- Jul 2017
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 | — |
Summary
The purpose of this study is to evaluate the effectiveness of OTO-104 for the treatment of Meniere's disease.
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). 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.