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

Primary Purpose

Hearing Loss, Sensorineural

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
AC102 gel
Prednisolone
Placebo Tablets
Placebo gel
Sponsored by
AudioCure Pharma GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hearing Loss, Sensorineural focused on measuring Hearing Loss, Hearing impairment, Hearing Loss, Sensorineural, Ear Diseases, Otorhinolaryngologic Diseases, Hearing Loss, Unilateral, Intratympanic Administration, Restoration of Hearing Loss

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Universitätsklinik für Hals-, Nasen- und OhrenheilkundeRecruiting
  • Ordensklinikum Linz GmbH Barmherzige SchwesternRecruiting
  • Universitätsklinik für Hals-Nasen-Ohren-KrankheitenRecruiting
  • Universitätsklinik für Hals-, Nasen- und OhrenkrankheitenRecruiting
  • Medical Institute of the Ministry of InteriorRecruiting
  • MHAT MMA, ENT Dept.Recruiting
  • Trakia HospitalRecruiting
  • FN sv. Anny - Klinika otorinolaryngologie a chirurgie hlavy a krkuRecruiting
  • Fakultní nemocnice Hradec KrálovéRecruiting
  • Pro-audio, s.r.o.Recruiting
  • Zdravotnická zařízení Olomouc, ORLRecruiting
  • Pardubická nemocnice, Klinika ORL a chirurgie hlavy a krkuRecruiting
  • ORL Poliklinika ModřanyRecruiting
  • Fakultní nemocnice v MotoleRecruiting
  • HNO PraxisRecruiting
  • Klinik und Poliklinik für Hals-, Nasen-, Ohrenkrankheiten, Kopf- und HalschirurgieRecruiting
  • HNO Facharztpraxis Alte PostRecruiting
  • Universitätsklinik und Poliklinik für Hals-, Nasen-, Ohrenheilkunde, Kopf- und HalschirurgieRecruiting
  • HNO am NeckarRecruiting
  • HNO Praxis HeidelbergRecruiting
  • Klinik für Hals-, Nasen- und Ohrenheilkunde am UniversitätsklinikumRecruiting
  • SRH Zentralklinikum Suhl GmbHRecruiting
  • Radboud University Medical CenterRecruiting
  • Bernhoven HospitalRecruiting
  • Centrum Medyczne Audika w BialymstokuRecruiting
  • Centrum Medyczne KwiatowaRecruiting
  • Centrum Medyczne MAVIT - Szpital Specjalistyczny KatowiceRecruiting
  • Kliniczny Szpital Wojewódzki Nr 1 im. Fryderyka Chopina w RzeszowieRecruiting
  • Centrum Medyczne LiMEDRecruiting
  • Clinical Hospital Centar "dr Dragisa Misovic-Dedinje"Recruiting
  • Clinical Hospital Centre ZvezdaraRecruiting
  • Clinical-Hospital Center ZemunRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

AC102

Prednisolone

Arm Description

AC102 gel and placebo tablets

Placebo gel and prednisolone tablets

Outcomes

Primary Outcome Measures

Change in pure tone audiometry (PTA; dB)
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
Scores between 0% to 100% correctly understood words at predefined sound pressure levels are determined

Full Information

First Posted
March 3, 2023
Last Updated
September 29, 2023
Sponsor
AudioCure Pharma GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT05776459
Brief Title
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 13, 2022 (Actual)
Primary Completion Date
October 30, 2024 (Anticipated)
Study Completion Date
December 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AudioCure Pharma GmbH

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss, Sensorineural
Keywords
Hearing Loss, Hearing impairment, Hearing Loss, Sensorineural, Ear Diseases, Otorhinolaryngologic Diseases, Hearing Loss, Unilateral, Intratympanic Administration, Restoration of Hearing Loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
210 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
AC102
Arm Type
Experimental
Arm Description
AC102 gel and placebo tablets
Arm Title
Prednisolone
Arm Type
Active Comparator
Arm Description
Placebo gel and prednisolone tablets
Intervention Type
Drug
Intervention Name(s)
AC102 gel
Intervention Description
Drug: AC102 Single intratympanic injection
Intervention Type
Drug
Intervention Name(s)
Prednisolone
Intervention Description
Active comparator: Prednisolone Tablets taken daily by mouth
Intervention Type
Other
Intervention Name(s)
Placebo Tablets
Intervention Description
Placebo Tablets taken daily by mouth
Intervention Type
Other
Intervention Name(s)
Placebo gel
Intervention Description
Placebo Single intratympanic injection
Primary Outcome Measure Information:
Title
Change in pure tone audiometry (PTA; dB)
Description
Mean change in absolute hearing thresholds measured by PTA from baseline to Day 28
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Absolute improvement of speech recognition measured in quiet compared to baseline using standardized word lists
Description
Scores between 0% to 100% correctly understood words at predefined sound pressure levels are determined
Time Frame
14, 28, 56, 84 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christin Galetzka
Phone
0049 30 221 839 780
Email
trials@audiocure.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reimar Schlingensiepen, MD
Organizational Affiliation
AudioCure Pharma GmbH
Official's Role
Study Director
Facility Information:
Facility Name
Universitätsklinik für Hals-, Nasen- und Ohrenheilkunde
City
Graz
ZIP/Postal Code
8036
Country
Austria
Individual Site Status
Recruiting
Facility Name
Ordensklinikum Linz GmbH Barmherzige Schwestern
City
Linz
ZIP/Postal Code
4010
Country
Austria
Individual Site Status
Recruiting
Facility Name
Universitätsklinik für Hals-Nasen-Ohren-Krankheiten
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Individual Site Status
Recruiting
Facility Name
Universitätsklinik für Hals-, Nasen- und Ohrenkrankheiten
City
Wien
ZIP/Postal Code
1090
Country
Austria
Individual Site Status
Recruiting
Facility Name
Medical Institute of the Ministry of Interior
City
Sofia
ZIP/Postal Code
1303
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
MHAT MMA, ENT Dept.
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Trakia Hospital
City
Stara Zagora
ZIP/Postal Code
6000
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
FN sv. Anny - Klinika otorinolaryngologie a chirurgie hlavy a krku
City
Brno
ZIP/Postal Code
656 91
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Fakultní nemocnice Hradec Králové
City
Hradec Králové
ZIP/Postal Code
500 05
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Pro-audio, s.r.o.
City
Mladá Boleslav
ZIP/Postal Code
293 01
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Zdravotnická zařízení Olomouc, ORL
City
Olomouc
ZIP/Postal Code
779 00
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Pardubická nemocnice, Klinika ORL a chirurgie hlavy a krku
City
Pardubice
ZIP/Postal Code
532 03
Country
Czechia
Individual Site Status
Recruiting
Facility Name
ORL Poliklinika Modřany
City
Prague
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Fakultní nemocnice v Motole
City
Praha
ZIP/Postal Code
150 06
Country
Czechia
Individual Site Status
Recruiting
Facility Name
HNO Praxis
City
Bad Schönborn
ZIP/Postal Code
76669
Country
Germany
Individual Site Status
Recruiting
Facility Name
Klinik und Poliklinik für Hals-, Nasen-, Ohrenkrankheiten, Kopf- und Halschirurgie
City
Greifswald
ZIP/Postal Code
17475
Country
Germany
Individual Site Status
Recruiting
Facility Name
HNO Facharztpraxis Alte Post
City
Göttingen
ZIP/Postal Code
37073
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsklinik und Poliklinik für Hals-, Nasen-, Ohrenheilkunde, Kopf- und Halschirurgie
City
Halle (Saale)
ZIP/Postal Code
06120
Country
Germany
Individual Site Status
Recruiting
Facility Name
HNO am Neckar
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Individual Site Status
Recruiting
Facility Name
HNO Praxis Heidelberg
City
Heidelberg
ZIP/Postal Code
69126
Country
Germany
Individual Site Status
Recruiting
Facility Name
Klinik für Hals-, Nasen- und Ohrenheilkunde am Universitätsklinikum
City
Jena
ZIP/Postal Code
07747
Country
Germany
Individual Site Status
Recruiting
Facility Name
SRH Zentralklinikum Suhl GmbH
City
Suhl
ZIP/Postal Code
98527
Country
Germany
Individual Site Status
Recruiting
Facility Name
Radboud University Medical Center
City
Nijmegen
ZIP/Postal Code
6525
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Bernhoven Hospital
City
Uden
ZIP/Postal Code
5406
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Centrum Medyczne Audika w Bialymstoku
City
Białystok
ZIP/Postal Code
15-232
Country
Poland
Individual Site Status
Recruiting
Facility Name
Centrum Medyczne Kwiatowa
City
Bydgoszcz
ZIP/Postal Code
85-047
Country
Poland
Individual Site Status
Recruiting
Facility Name
Centrum Medyczne MAVIT - Szpital Specjalistyczny Katowice
City
Katowice
ZIP/Postal Code
40-431
Country
Poland
Individual Site Status
Recruiting
Facility Name
Kliniczny Szpital Wojewódzki Nr 1 im. Fryderyka Chopina w Rzeszowie
City
Rzeszów
ZIP/Postal Code
35-055
Country
Poland
Individual Site Status
Recruiting
Facility Name
Centrum Medyczne LiMED
City
Tarnowskie Góry
ZIP/Postal Code
42-600
Country
Poland
Individual Site Status
Recruiting
Facility Name
Clinical Hospital Centar "dr Dragisa Misovic-Dedinje"
City
Belgrade
ZIP/Postal Code
11040
Country
Serbia
Individual Site Status
Recruiting
Facility Name
Clinical Hospital Centre Zvezdara
City
Belgrade
ZIP/Postal Code
11050
Country
Serbia
Individual Site Status
Recruiting
Facility Name
Clinical-Hospital Center Zemun
City
Belgrade
ZIP/Postal Code
11080
Country
Serbia
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

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

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