Phase 3 Study of OTO-104 in Subjects With Unilateral Meniere's Disease
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ClinicalTrials.gov Identifier: NCT03664674 |
Recruitment Status :
Completed
First Posted : September 10, 2018
Last Update Posted : February 15, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Meniere Disease | Drug: OTO-104 Drug: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 149 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Randomized, Double-blind, Placebo-controlled, Multicenter |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Prospective, Randomized, Double Blind, Placebo-controlled, Multicenter, Phase 3 Efficacy and Safety Study of OTO-104 Given as a Single Intratympanic Injection in Subjects With Unilateral Meniere's Disease |
Actual Study Start Date : | August 27, 2018 |
Actual Primary Completion Date : | December 22, 2020 |
Actual Study Completion Date : | December 22, 2020 |

Arm | Intervention/treatment |
---|---|
Experimental: OTO-104 |
Drug: OTO-104
Single intratympanic injection of 12 mg dexamethasone |
Placebo Comparator: placebo |
Drug: Placebo
Single intratympanic injection of placebo |
- The number of definitive vertigo days [ Time Frame: 3 months ]subject diary
- Audiometry [ Time Frame: 3 months ]assessment of hearing function
- Otoscopic examination - use of an otoscope to assess the health of the ear [ Time Frame: 3 months ]assessment of the auditory canal and tympanic membrane
- Adverse events [ Time Frame: 3 months ]medical events reported by the subject
- Impact of vertigo experience on daily activities [ Time Frame: 3 Months ]subject diary

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Ages Eligible for Study: | 18 Years to 85 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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:
- Subject is pregnant or lactating.
- Subject has a history of immunodeficiency disease.
- Subject has a history of significant middle ear or inner ear surgery, or endolymphatic sac surgery in the affected ear.
- Subject has a history of tympanostomy tubes with evidence of perforation or lack of closure.
- Subject has a history of vestibular migraine.
- Subject has used an investigational drug or device in the 3 months prior to screening.
- Subject has previously been randomized to a clinical study of OTO-104.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03664674

Responsible Party: | Otonomy, Inc. |
ClinicalTrials.gov Identifier: | NCT03664674 |
Other Study ID Numbers: |
104-201811 |
First Posted: | September 10, 2018 Key Record Dates |
Last Update Posted: | February 15, 2021 |
Last Verified: | February 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Meniere's Disease Vertigo Endolymphatic Hydrops |
Labyrinth Diseases Ear Diseases Otorhinolaryngologic Diseases |
Meniere Disease Endolymphatic Hydrops Labyrinth Diseases Ear Diseases Otorhinolaryngologic Diseases |