Idiopathic Sudden Sensorineural Hearing Loss (ISSNHL) ISSNHL is most commonly defined as sensorineural hearing loss of 30dB or greater over at least three contiguous audiometric frequencies occurring within a 72-hr period. Inclusion within this trial applies for moderately severe to profound cases ( 65 to <100 dB) within 24 to 120 hours after onset.
Conditions
Interventions
Product Name: -
Product Code: AC102
Pharmaceutical Form: Gel for injection
INN or Proposed INN: not yet assigned
CAS Number: 1688675-80-0
Current Sponsor code: AC102
Other descriptive name: 6-fluor
Sponsors
AudioCure Pharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed Institutional Review Board (IRB) / Independent Ethics Committee (IEC) approved informed consent form (ICF) 2. Female or male patients aged between 18 and 80 years (inclusive) at the day of Screening 3. Unilateral ISSNHL 4. Onset of unilateral ISSNHL between 24 to 120 hours prior to randomization 5. Patients with an absolute air conduction hearing threshold of at least 65 dB, but less than 100 dB (average of the three most affected consecutive frequencies between 0.25 and 8 kHz). 6. Patients with a relative hearing loss of at least 40 dB compared to the current audiogram of the non-affected ear. 7. Willing and able to use adequate hearing protection and to refrain from engaging in activities or work involving loud noise exposure where sufficient hearing protection is not possible or ensured for the duration of their participation in this study 8. Willing and able to protect the ear canal and middle ear from water exposure for as long as the tympanic membrane is not fully closed 9. Willing and able to attend the trial visits 10. Able to read and understand trial documents and follow Investigator and trial personnel instructions during visits. Willing and able to comply with procedures of audiological assessments (in particular pure tone audiometry and speech audiometry). 11. Female patients must meet one of the following criteria: • If of childbearing potential – have a negative urine pregnancy test and agree to use a highly effective medically accepted contraceptive method for at least 30 days after the last study medication intake. • If of non-childbearing potential – should be surgically sterile (i.e. has undergone complete hysterectomy, bilateral oophorectomy, or bilateral tubal ligation) or in a postmenopausal state (at least one year without menses at Screening) Male patients with sexual partners who could become pregnant must meet the following criteria: • Patient is unable to procreate, defined as surgically sterile (i.e. has undergone a vasectomy at last 6 months before Screening) • Patient agrees to use one of the accepted contraceptive regimens for at least 30 days after the last study medication intake. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 140 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 70
Exclusion criteria
Exclusion criteria: 1. Insufficient handling of the language used in the speech audiometry tests 2. a) Bilateral acute hearing loss b) Sudden hearing loss in the only hearing ear (i.e. pre-existing hearing loss in the contralateral ear of 40 dB or more measured by PTA in the range of 0.5-4 kHz) 3. Acute hearing loss from noise trauma, barotrauma or head trauma in either ear at any time 4. Congenital hearing loss 5. Conductive hearing loss or combined hearing loss determined by a 4PTA > 10 dB 6. Suspected perilymph fistula or round window membrane rupture in either ear 7. Otitis media or otitis externa that is ongoing or ended within 30 days prior to randomization or is occurring several times per year 8. Patients with abnormality of the tympanic membrane or the outer ear canal that would preclude intratympanic administration 9. Evidence or history of vestibular schwannoma (acoustic neuroma) or other retrocochlear damage in the affected ear 10. History of ISSNHL in the past 2 years 11. History of radiation-induced hearing loss, fluctuating hearing, endolymphatic hydrops or Menière’s disease in either ear 12. History of chronic inflammatory or chronic suppurative ear disease or cholesteatoma in the affected ear 13. History of otosclerosis in the affected ear 14. Family history of hearing impairment other than age related 15. History within the past 2 years or presence of drug abuse or alcoholism based on patient reports and judgment of the investigator 16. Positive urine screen of drugs of abuse at Screening 17. Acute SARS-CoV-2 infection (antigen-test) 18. If any of the following diseases is known: • Human immunodeficiency virus (HIV), hepatitis B, or hepatitis C infection • Systemic mycosis and parasitosis (amoebic or worm infections) • Acute and chronic bacterial infections • Tuberculosis • Severe osteoporosis • Narrow and wide-angle glaucoma, corneal ulceration and corneal injury • Severe ulcerative colitis with impending perforation, with abscesses or purulent inflammations • Exercise-induced angina, known class III or IV heart failure, as defined by the New York Heart Association (NYHA) functional classification system • Gastric or duodenal ulcer, existing or treated within 180 mmHg) or diastolic (>100 mmHg) blood pressure at Screening 20. Difficult to control diabetes. 21. Treatment with medication listed in 4.4. of the protocol. 22. Patients who have answered “yes” to questions 4 or 5 of the C-SSRS. 23. Hypersensitivity to prednisolone 24. Vaccination with live vaccines or mRNA or vector vaccines planned in the next 8 weeks or that was less than 2 weeks ago 25. Concurrent participation in another clinical study or participation in another clinical study within 30 days or 5 half-lives of the respective experimental drug (whichever is longer) prior to Screening Visit 26. Women who are breast feeding, pregnant or plan to become pregnant during the study or women of childbearing potential who are unwilling or unable to practice an effective method of contraception 27. Patients who are involved in the organization of the clinical investigation or are in any way dependent on the Investigator or Sponsor 28. Major surgery within eight weeks before Screening or schedul
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Efficacy of a single dose administration of AC102 compared to oral steroids in patients with moderately-severe to profound ISSNHL. The evaluation will be based on the improvement of the hearing threshold (average of the three most affected consecutive frequencies) tested by pure tone audiometry from baseline to Day 28. ;Secondary Objective: • Improvement of the hearing threshold over the time course of the whole study duration (up to Day 84) tested by pure tone audiometry • Improvement of speech recognition in quiet over the time course of the study focusing on the final test at Day 84 • Incidence of complete, partial and no recovery • Percentage of patients eligible for salvage therapy • Improvement of Hearing Handicap Inventory Score/ Quality of Life • Safety and tolerability ;Primary end point(s): Mean change in absolute hearing thresholds (average of the three most affected consecutive frequencies from 0.25 to 8 kHz) measured by PTA from baseline to Day 28 ;Timepoint(s) of evaluation of this end point: from baseline to Day 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Absolute improvement of speech recognition from baseline to Day 84 • Mean change in absolute hearing thresholds of PTA from baseline to Day 14, 56 and 84 at the three mostly affected consecutive frequencies and mean change of 4PTA (PTA at the frequencies 0.5, 1, 2, and 4 kHz) • Percentage of patients with complete, partial or no remission on Day 28, 56 and 84 based on Wilson's criteria (no recovery: = 10 dB, complete: within 10 dB to the contralateral ear) • Absolute improvement of speech recognition in quiet from baseline to Day 14, 28 and 56 • Percentage of patients eligible for salvage therapy • Improvement of scoring in HHIA from baseline to Day 28 and 84 ;Timepoint(s) of evaluation of this end point: • Absolute improvement of speech recognition from baseline to Day 84 • Mean change in absolute hearing thresholds of PTA from baseline to Day 14, 56 and 84 at the three mostly affected consecutive frequencies and mean change of 4PTA (PTA at the frequencies 0.5, 1, 2, and 4 kHz) • Percentage of patients with complete, partial or no remission on Day 28, 56 and 84 • Absolute improvement of speech recognition in quiet from baseline to Day 14, 28 and 56 • Percentage of patients eligible for salvage therapy • Improvement of scoring in HHIA from baseline to Day 28 and 84 | — |
Countries
Austria, Bulgaria, Czechia, Czech Republic, Germany, Netherlands, Poland, Russian Federation, Serbia
Contacts
Public ContactClinical Research
Audiocure Pharma GmbH
Outcome results
None listed