A study to see of local application (in the ear) of dexamethasone (a corticosteroid) to people with Meniere's disease could help with their symptoms and if it is safe to use.

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.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-004496-71-GB

Enrollment

160

Registered

2015-12-15

Start date

2016-03-01

Completion date

Unknown

Last updated

2019-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Meniere's disease MedDRA version: 20.0 Level: PT Classification code 10027183 Term: Meniere's disease System Organ Class: 10013993 - Ear and labyrinth disorders

Interventions

Product Name: OTO-104 Product Code: OTO-104 Pharmaceutical Form: Powder and solvent for suspension for injection INN or Proposed INN: DEXAMETHASONE

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Subject is a male or female aged 18 to 85 years, inclusive. - Subject has a diagnosis of definite unilateral Meniere’s disease by 1995 AAO-HNS criteria. - Subject self-reports active, definitive vertigo episodes for the 2 months prior to the study lead-in period. - Subject has documented asymmetric sensorineural hearing loss at screening or within the past 12 months according to AAO-HNS 1995 criteria defined as one of the following: a. The arithmetic mean of hearing thresholds (pure tone average, PTA) at 250, 500 and 1000 Hz of 15 dB or more higher than the PTA of 1000, 2000, and 3000 Hz, b. The arithmetic mean of PTA at 500, 1000, 2000 and 3000 Hz is 20 dB or more poorer in the ear in question than on the opposite side, c. It is the judgment of the investigator that the subject’s hearing loss meets reasonable audiometric criteria for hearing loss characteristic of Meniere’s disease, and if so, it should be justified and documented. - Subject is able to use the telephone to complete their daily diary. At the completion of the first 28 days of the lead-in period: - Subject completed at least 22 of 28 diary entries during the 4-week lead-in period. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 120 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40

Exclusion criteria

Exclusion criteria: - Subject has an infection in the ear, sinuses, or upper respiratory system at the time of randomization. - Subject is pregnant or lactating. - Subject has a history of immunodeficiency disease. - Subject has an abnormality of the tympanic membrane in the affected ear that would increase the risk associated with intratympanic injection including but not limited to monomeric tympanic membrane. - Subject has used systemic steroids within 1 month prior to entering the lead-in period. - Subject has previously been randomized to a trial of OTO-104.

Design outcomes

Primary

Measure	Time frame
Main Objective: To confirm the efficacy of OTO-104 in subjects with Meniere’s disease, as measured by the number of definitive vertigo days (DVD) at Week 12 (the 4-week interval from Week 9 through Week 12).;Secondary Objective: To describe the safety profile of OTO-104 in subjects with Meniere’s disease.;Primary end point(s): The number of definitive vertigo days (DVD) at Week 12 [the 4-week (28-day) interval from Week 9 through Week 12];Timepoint(s) of evaluation of this end point: Week 12	—

Measure

Time frame

Main Objective: To confirm the efficacy of OTO-104 in subjects with Meniere’s disease, as measured by the number of definitive vertigo days (DVD) at Week 12 (the 4-week interval from Week 9 through Week 12).;Secondary Objective: To describe the safety profile of OTO-104 in subjects with Meniere’s disease.;Primary end point(s): The number of definitive vertigo days (DVD) at Week 12 [the 4-week (28-day) interval from Week 9 through Week 12];Timepoint(s) of evaluation of this end point: Week 12

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Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: Week 4, Week 8, Week 12 as specified in the endpoint description.; Secondary end point(s): - The number of definitive vertigo days (DVD) at Week 8 [the 4-week (28-day) interval from Week 5 through Week 8] - The number of definitive vertigo days (DVD) at Week 4 [the 4-week (28-day) interval from Week 1 through Week 4] - The change from baseline in vertigo frequency (VF) during the 4-week study interval (Week 9 through Week 12), where vertigo frequency is defined as the proportion of days during the 4-week interval where a definitive vertigo episode was recorded divided by the number of non-missing diary entries for the relevant interval The change from baseline with respect to severity of vertigo episodes as measured by the mean Vertigo Score during the 4-week study interval (Week 9 through Week 12) - The change from baseline in average daily count of vertigo episodes, during the 4-week study interval (Week 9 through Week 12) - Occurrence of Normal activity, Slight limitation, Moderate limitation, Sick at home, and Bed ridden events as a consequence of vertigo at Week 12 - SF-36 at Week 12 o Physical Health Summary Measure o Mental Health Summary Measure o 8 Scales	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: Week 4, Week 8, Week 12 as specified in the endpoint description.; Secondary end point(s): - The number of definitive vertigo days (DVD) at Week 8 [the 4-week (28-day) interval from Week 5 through Week 8] - The number of definitive vertigo days (DVD) at Week 4 [the 4-week (28-day) interval from Week 1 through Week 4] - The change from baseline in vertigo frequency (VF) during the 4-week study interval (Week 9 through Week 12), where vertigo frequency is defined as the proportion of days during the 4-week interval where a definitive vertigo episode was recorded divided by the number of non-missing diary entries for the relevant interval The change from baseline with respect to severity of vertigo episodes as measured by the mean Vertigo Score during the 4-week study interval (Week 9 through Week 12) - The change from baseline in average daily count of vertigo episodes, during the 4-week study interval (Week 9 through Week 12) - Occurrence of Normal activity, Slight limitation, Moderate limitation, Sick at home, and Bed ridden events as a consequence of vertigo at Week 12 - SF-36 at Week 12 o Physical Health Summary Measure o Mental Health Summary Measure o 8 Scales

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Countries

Belgium, France, Germany, Italy, Poland, United Kingdom

Contacts

Public ContactClinical Project Manager

Otonomy Inc.

16193232200

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026