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
Status: Recruiting
Location: See all (36) locations...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Austria
Universitätsklinik für Hals-, Nasen- und Ohrenheilkunde
RECRUITING
Graz
Ordensklinikum Linz GmbH Barmherzige Schwestern
RECRUITING
Linz
Universitätsklinik für Hals-Nasen-Ohren-Krankheiten
RECRUITING
Salzburg
Universitätsklinik für Hals-, Nasen- und Ohrenkrankheiten
RECRUITING
Vienna
Germany
Klinik für Hals-, Nasen-, Ohrenheilkunde - Charité Campus Benjamin Franklin - HNO Hochschulambulanz
RECRUITING
Berlin
University Hospital Dresden 'Carl Gustav Carus' - HNO
RECRUITING
Dresden
Klinik und Poliklinik für Hals-, Nasen-, Ohrenkrankheiten, Kopf- und Halschirurgie
RECRUITING
Greifswald
Universitätsklinik und Poliklinik für Hals-, Nasen-, Ohrenheilkunde, Kopf- und Halschirurgie
RECRUITING
Halle
HNO Praxis Heidelberg
RECRUITING
Heidelberg
Klinik für Hals-, Nasen- und Ohrenheilkunde am Universitätsklinikum
RECRUITING
Jena
Johannes Weseling Clinic Minden
RECRUITING
Minden
Evangelisches Krankenhaus - Universitätsklinik für HNO
RECRUITING
Oldenburg
Universitätsklinikum Regensburg - Klinik für HNO-Heilkunde
RECRUITING
Regensburg
SRH Zentralklinikum Suhl GmbH
RECRUITING
Suhl
Universitätsklinikum HNO
RECRUITING
Würzburg
Netherlands
Radboud University Medical Center
RECRUITING
Nijmegen
Bernhoven Hospital
RECRUITING
Uden
Poland
Centrum Medyczne Kwiatowa
RECRUITING
Bydgoszcz
Centrum Medyczne MAVIT - Szpital Specjalistyczny Katowice
RECRUITING
Katowice
ALL-MED Cetrum Medyczne
RECRUITING
Lodz
Centrum Słuchu i Mowy Sp. z o.o.
RECRUITING
Nadarzyn
Oddział Laryngologii
RECRUITING
Opole
Kliniczny Szpital Wojewódzki Nr 1 im. Fryderyka Chopina w Rzeszowie
RECRUITING
Rzeszów
Uniwersytecki Szpital Kliniczny Nr 1
RECRUITING
Szczecin
Centrum Zdrowia MDM
RECRUITING
Warsaw
Trialmed
RECRUITING
Warsaw
Serbia
Clinical Hospital Centar dr Dragisa Misovic-Dedinje
RECRUITING
Belgrade
Clinical Hospital Centre Zvezdara
RECRUITING
Belgrade
Clinical-Hospital Center Zemun
RECRUITING
Belgrade
Military Medical Academy - ENT department
RECRUITING
Belgrade
University Clinical Centre of Serbia
RECRUITING
Belgrade
Ukraine
Communal non-profit enterprise Central city clinical hospital of Ivano-Frankivsk city council
RECRUITING
Ivano-frankivsk
Municipal non-profit enterprise Regional Clinical Hospital of Ivano-Frankivsk Regional Council
RECRUITING
Ivano-frankivsk
MC Universal Clinic Oberig of Kapytal LLC
RECRUITING
Kyiv
Municipal non-profit enterprise Oleksandrivska clinical hospital of Kyiv of the executive body of Kyiv city council
RECRUITING
Kyiv
LLC Clinic of Healthy Family Astramed
RECRUITING
Uzhhorod
Contact Information
Primary
Christin Galetzka
trials@audiocure.com
0049 30 221 839 780
Time Frame
Start Date: 2022-10-13
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 210
Treatments
Experimental: AC102
AC102 gel and placebo tablets
Active_comparator: Prednisolone
Placebo gel and prednisolone tablets
Related Therapeutic Areas
Sponsors
Leads: AudioCure Pharma GmbH