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

Hearing Loss, Sensorineural Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05776459
• Other study ID #: AC102-201
• Status: Recruiting
• Phase: Phase 2
• Start date: October 13, 2022
• Est. completion date: December 30, 2024

Study information

• Verified date: November 2023
• Source: AudioCure Pharma GmbH
• Contact: Christin Galetzka
• Phone: 0049 30 221 839 780
• Email: trials[@]audiocure.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 210
• Est. completion date: December 30, 2024
• Est. primary completion date: October 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Deafness
• Hearing Loss
• Hearing Loss, Sensorineural

Intervention

Drug:
• AC102 gel
Drug: AC102 Single intratympanic injection
• Prednisolone
Active comparator: Prednisolone Tablets taken daily by mouth

Other:
• Placebo Tablets
Placebo Tablets taken daily by mouth
• Placebo gel
Placebo Single intratympanic injection

Locations

Country	Name	City	State
Austria	Universitätsklinik für Hals-, Nasen- und Ohrenheilkunde	Graz
Austria	Ordensklinikum Linz GmbH Barmherzige Schwestern	Linz
Austria	Universitätsklinik für Hals-Nasen-Ohren-Krankheiten	Salzburg
Austria	Universitätsklinik für Hals-, Nasen- und Ohrenkrankheiten	Wien
Czechia	Fakultní nemocnice Hradec Králové	Hradec Králové
Czechia	Pro-audio, s.r.o.	Mladá Boleslav
Czechia	Zdravotnická zarízení Olomouc, ORL	Olomouc
Czechia	Pardubická nemocnice, Klinika ORL a chirurgie hlavy a krku	Pardubice
Czechia	ORL Poliklinika Modrany	Prague
Czechia	Fakultní nemocnice v Motole	Praha
Germany	HNO Praxis	Bad Schönborn
Germany	HNO Facharztpraxis Alte Post	Göttingen
Germany	Klinik und Poliklinik für Hals-, Nasen-, Ohrenkrankheiten, Kopf- und Halschirurgie	Greifswald
Germany	Universitätsklinik und Poliklinik für Hals-, Nasen-, Ohrenheilkunde, Kopf- und Halschirurgie	Halle (Saale)
Germany	HNO am Neckar	Heidelberg
Germany	HNO Praxis Heidelberg	Heidelberg
Germany	Klinik für Hals-, Nasen- und Ohrenheilkunde am Universitätsklinikum	Jena
Germany	Johannes Weseling Clinic Minden	Minden
Germany	SRH Zentralklinikum Suhl GmbH	Suhl
Netherlands	Canisius Wilhelmina Hospital	Nijmegen
Netherlands	Radboud University Medical Center	Nijmegen
Netherlands	Bernhoven Hospital	Uden
Poland	Centrum Medyczne Audika w Bialymstoku	Bialystok
Poland	Centrum Medyczne Kwiatowa	Bydgoszcz
Poland	Centrum Medyczne MAVIT - Szpital Specjalistyczny Katowice	Katowice
Poland	Kliniczny Szpital Wojewódzki Nr 1 im. Fryderyka Chopina w Rzeszowie	Rzeszów
Poland	Centrum Medyczne LiMED	Tarnowskie Góry
Serbia	Clinical Hospital Centar "dr Dragisa Misovic-Dedinje"	Belgrade
Serbia	Clinical Hospital Centre Zvezdara	Belgrade
Serbia	Clinical-Hospital Center Zemun	Belgrade
Serbia	University Clinical Centre of Serbia	Belgrade

Sponsors (1)

Lead Sponsor	Collaborator
AudioCure Pharma GmbH

Countries where clinical trial is conducted

Austria,  Czechia,  Germany,  Netherlands,  Poland,  Serbia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in pure tone audiometry (PTA; dB)	Mean change in absolute hearing thresholds measured by PTA from baseline to Day 28	28 days
Secondary	Absolute improvement of speech recognition measured in quiet compared to baseline using standardized word lists	Scores between 0% to 100% correctly understood words at predefined sound pressure levels are determined	14, 28, 56, 84 days