NCT05776459Active, not recruitingPhase 2
Phase II, Multi-Center, Randomized, Blinded Study Evaluating the Efficacy, Safety and Tolerability of a Single Intratympanic Dose of AC102 Compared to Oral Steroids for the Treatment of Idiopathic Sudden Sensorineural Hearing Loss
AudioCure Pharma GmbH39 sites in 6 countries210 target enrollmentStarted: October 13, 2022Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Active, not recruiting
- Sponsor
- AudioCure Pharma GmbH
- Enrollment
- 210
- Locations
- 39
- Primary Endpoint
- Change in pure tone audiometry (PTA; dB)
Study Overview
Brief Summary
The purpose of this Phase 2 clinical trial is to evaluate the safety, tolerability and efficacy of AC102 administered as single intratympanic injection compared to oral steroid treatment in patients with Idiopathic Sudden Sensorineural Hearing Loss (ISSNHL).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Male or female patients aged between 18 and 85 years
- •Unilateral ISSNHL
- •Onset of unilateral ISSNHL between 24 to 120 hours prior to randomization
- •An absolute air conduction hearing threshold of at least 65 dB,
- •Patients with a relative hearing loss of at least 30 dB compared to the current audiogram of the non-affected ear
Exclusion Criteria
- •Insufficient handling of the language used in the speech audiometry tests
- •Bilateral hearing loss
- •Acute hearing loss from noise trauma, barotrauma or head trauma in either ear at any time
- •Congenital hearing loss
- •Conductive hearing loss or combined hearing loss determined by a 4PTA > 10 dB
- •History of ISSNHL in the past 1 years in the affected ear
Arms & Interventions
Prednisolone
Active Comparator
Placebo gel and prednisolone tablets
Intervention: Prednisolone (Drug)
AC102
Experimental
AC102 gel and placebo tablets
Intervention: AC102 gel (Drug)
AC102
Experimental
AC102 gel and placebo tablets
Intervention: Placebo Tablets (Other)
Prednisolone
Active Comparator
Placebo gel and prednisolone tablets
Intervention: Placebo gel (Other)
Outcomes
Primary Outcomes
Change in pure tone audiometry (PTA; dB)
Time Frame: 28 days
Mean change in absolute hearing thresholds measured by PTA from baseline to Day 28
Secondary Outcomes
- Absolute improvement of speech recognition measured in quiet compared to baseline using standardized word lists(14, 28, 56, 84 days)
Investigators
Study Sites (39)
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