Efficacy and Safety of AC102 Compared to Steroids in Adults With Idiopathic Sudden Sensorineural Hearing Loss (ISSNHL)

Sponsor

AudioCure Pharma GmbH (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05776459

Collaborator

(none)

210

Enrollment

Location

Arms

26.6

Anticipated Duration (Months)

7.9

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Hearing Loss, Sensorineural	Drug: AC102 gel Drug: Prednisolone Other: Placebo Tablets Other: Placebo gel	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

210 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 13, 2022

Anticipated Primary Completion Date :

Oct 30, 2024

Anticipated Study Completion Date :

Dec 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: AC102 AC102 gel and placebo tablets	Drug: AC102 gel Drug: AC102 Single intratympanic injection Other: Placebo Tablets Placebo Tablets taken daily by mouth
Active Comparator: Prednisolone Placebo gel and prednisolone tablets	Drug: Prednisolone Active comparator: Prednisolone Tablets taken daily by mouth Other: Placebo gel Placebo Single intratympanic injection

Arm

Intervention/Treatment

Experimental: AC102

AC102 gel and placebo tablets

Drug: AC102 gel

Drug: AC102 Single intratympanic injection

Other: Placebo Tablets

Placebo Tablets taken daily by mouth

Active Comparator: Prednisolone

Placebo gel and prednisolone tablets

Drug: Prednisolone

Active comparator: Prednisolone Tablets taken daily by mouth

Other: Placebo gel

Placebo Single intratympanic injection

Outcome Measures

Primary Outcome Measures

Change in pure tone audiometry (PTA; dB) [28 days]
Mean change in absolute hearing thresholds measured by PTA from baseline to Day 28

Secondary Outcome Measures

Absolute improvement of speech recognition measured in quiet compared to baseline using standardized word lists [14, 28, 56, 84 days]
Scores between 0% to 100% correctly understood words at predefined sound pressure levels are determined

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Male or female patients aged between 18 and 80 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, but less than 100 dB
Patients with a relative hearing loss of at least 40 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 2 years