Clinical trial NCT05776459: Efficacy and Safety of AC102 Compared to Steroids in Adults with Idiopathic Sudden Sensorineural Hearing Loss (ISSNHL)
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Hearing Loss, Sensorineural
Keywords: Hearing Loss
Hearing impairment
Hearing Loss, Sensorineural
Ear Diseases
Otorhinolaryngologic Diseases
Hearing Loss, Unilateral
Intratympanic Administration
Restoration of Hearing Loss
Lead sponsor: AudioCure Pharma GmbH
Sponsor class: INDUSTRY
First posted: 2023-03-20
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Change in pure tone audiometry (PTA; dB)
timeFrame: 28 days
Secondary outcomes:
measure: Absolute improvement of speech recognition measured in quiet compared to baseline using standardized word lists
timeFrame: 14, 28, 56, 84 days
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Universitätsklinik für Hals-, Nasen- und Ohrenheilkunde
city: Linz
country: Austria
facility: Ordensklinikum Linz GmbH Barmherzige Schwestern
city: Salzburg
country: Austria
facility: Universitätsklinik für Hals-Nasen-Ohren-Krankheiten
city: Wien
country: Austria
facility: Universitätsklinik für Hals-, Nasen- und Ohrenkrankheiten
city: Hradec Králové
country: Czechia
facility: Fakultní nemocnice Hradec Králové
city: Olomouc
country: Czechia
facility: Zdravotnická zařízení Olomouc, ORL
city: Pardubice
country: Czechia
facility: Pardubická nemocnice, Klinika ORL a chirurgie hlavy a krku
city: Praha
country: Czechia
facility: Fakultní nemocnice v Motole
city: Berlin
country: Germany
facility: Klinik für Hals-, Nasen-, Ohrenheilkunde - Charité Campus Benjamin Franklin - HNO Hochschulambulanz
city: Dresden
country: Germany
facility: University Hospital Dresden 'Carl Gustav Carus' - HNO
city: Greifswald
country: Germany
facility: Klinik und Poliklinik für Hals-, Nasen-, Ohrenkrankheiten, Kopf- und Halschirurgie
city: Halle (Saale)
country: Germany
facility: Universitätsklinik und Poliklinik für Hals-, Nasen-, Ohrenheilkunde, Kopf- und Halschirurgie
city: Heidelberg
country: Germany
facility: HNO Praxis Heidelberg
city: Jena
country: Germany
facility: Klinik für Hals-, Nasen- und Ohrenheilkunde am Universitätsklinikum
city: Minden
country: Germany
facility: Johannes Weseling Clinic Minden
city: Oldenburg
country: Germany
facility: Evangelisches Krankenhaus - Universitätsklinik für HNO
city: Regensburg
country: Germany
facility: Universitätsklinikum Regensburg - Klinik für HNO-Heilkunde
city: Suhl
country: Germany
facility: SRH Zentralklinikum Suhl GmbH
city: Würzburg
country: Germany
facility: Universitätsklinikum HNO
city: Nijmegen
country: Netherlands
facility: Radboud University Medical Center
city: Uden
country: Netherlands
facility: Bernhoven Hospital
city: Bydgoszcz
country: Poland
facility: Centrum Medyczne Kwiatowa
city: Katowice
country: Poland
facility: Centrum Medyczne MAVIT - Szpital Specjalistyczny Katowice
city: Nadarzyn
country: Poland
facility: Centrum Słuchu i Mowy Sp. z o.o.
city: Opole
country: Poland
facility: Oddział Laryngologii
city: Rzeszów
country: Poland
facility: Kliniczny Szpital Wojewódzki Nr 1 im. Fryderyka Chopina w Rzeszowie
city: Szczecin
country: Poland
facility: Uniwersytecki Szpital Kliniczny Nr 1
city: Warsaw
country: Poland
facility: Centrum Zdrowia MDM
city: Warsaw
country: Poland
facility: Trialmed
city: Łódź
country: Poland
facility: ALL-MED Cetrum Medyczne
city: Belgrade
country: Serbia
facility: University Clinical Centre of Serbia
city: Belgrade
country: Serbia
facility: Clinical Hospital Centar "dr Dragisa Misovic-Dedinje"
city: Belgrade
country: Serbia
facility: Clinical Hospital Centre Zvezdara
city: Belgrade
country: Serbia
facility: Clinical-Hospital Center Zemun
city: Belgrad
country: Serbia
facility: Military Medical Academy - ENT department
city: Ivano-Frankivs'k
country: Ukraine
facility: Municipal non-profit enterprise Regional Clinical Hospital of Ivano-Frankivsk Regional Council
city: Ivano-Frankivsk
country: Ukraine
facility: Communal non-profit enterprise "Central city clinical hospital of Ivano-Frankivsk city council"
city: Kyiv
country: Ukraine
facility: Municipal non-profit enterprise Oleksandrivska clinical hospital of Kyiv of the executive body of Kyiv city council
city: Kyiv
country: Ukraine
facility: MC Universal Clinic Oberig of Kapytal LLC
city: Úzhgorod
country: Ukraine
facility: LLC Clinic of Healthy Family Astramed
Study officials:
affiliation: AudioCure Pharma GmbH
name: Reimar Schlingensiepen, MD
role: STUDY_DIRECTOR
References: