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

104-201811

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

2018-08-27

2020-12-22

2020-12-22

Completed

Early phase I

148

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized, Double-blind, Placebo-controlled, Multicenter', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 148, 'type': 'ACTUAL'}}

2022-12-07