Phase 1 Study of SPT-2101 Given as a Single Intratympanic Injection in Subjects with Unilateral Meniere's Disease

Phase 1

Recruiting

• Conditions: nilateral Meniere's Disease; Unilateral Meniere's Disease; Ear - Other ear disorders

• Registration Number: ACTRN12621000964819
• Lead Sponsor: Spiral Therapeutics Australia Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-23
• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Age 18 years to 85 years (inclusive) at the time of screening
2. Provides written informed consent prior to participation in any study procedure
3. Has a diagnosis of unilateral Definite Meniere's disease defined by the Classification Committee of the Bárány Society or the American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS)
4. Self-reports active, definitive vertigo (lasting 20 minutes or more) in the 3 months prior to screening and records 2 or more Definitive Vertigo Days in the lead-in period.
5. Has documented acquired asymmetric sensorineural hearing loss, as reported by the patient or documented by audiometric testing

Exclusion Criteria

1. Ongoing chronic inflammatory or infectious middle ear disease
2. Active infection in the ear, sinuses, or upper respiratory system
3. Current tympanic membrane perforation, including ventilation tube, in the affected ear.
4. Active benign paroxysmal positional vertigo (BPPV) symptoms
5. History of superior canal dehiscence

Study & Design

• Study Type: Interventional
• Study Design: Not specified