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OTO-413 in Subjects With Speech-in-Noise Hearing Impairment
Phase 1 & 2
Waitlist Available
Research Sponsored by Otonomy, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 2 weeks (dependent on dose group), 4 weeks, 8 weeks and 12 weeks after dosing
Summary
This trial is testing a medication called OTO-413, which is injected into the ear, to help people who have trouble hearing speech in noisy environments. OTO-413 is a formulation of brain derived neurotrophic factor (BDNF) that has shown potential to improve hearing function.
Eligible Conditions
- Sensorineural Hearing Loss
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 2 weeks (dependent on dose group), 4 weeks, 8 weeks and 12 weeks after dosing
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 2 weeks (dependent on dose group), 4 weeks, 8 weeks and 12 weeks after dosing
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Audiometry (Safety)
Otoscopic Examinations (Safety)
Treatment Emergent Adverse Events (Safety)
Other study objectives
Electrophysiological Endpoint (dependent on dose group)
Patient Global Impression of Change
Speech-in-noise Hearing Tests
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: OTO-413Experimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention
Find a Location
Who is running the clinical trial?
Otonomy, Inc.Lead Sponsor
21 Previous Clinical Trials
3,009 Total Patients Enrolled