Phase 3 Study of OTO-104 in Subjects With Unilateral Meniere's Disease

Otonomy

Status and phase: Completed; Phase 3

Conditions: Meniere Disease

Treatments: Drug: Placebo; Drug: OTO-104

Study type: Interventional

Funder types: Industry

Identifiers

NCT03664674

104-201811

Details and patient eligibility

About

The purpose of this study is to evaluate the effectiveness of OTO-104 for the treatment of Meniere's disease.

Enrollment: 148 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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148 participants in 2 patient groups, including a placebo group

OTO-104

Experimental group

Treatment:

Drug: OTO-104

placebo

Placebo Comparator group

Treatment:

Drug: Placebo