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

• Status: Completed
• Trial end date: 2020-12-22
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Otonomy, Inc.

Criteria

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.