A Study to Evaluate the Efficacy, Safety and Tolerability of a Single Injection of AC102 into the Middle Ear Compared to Oral Steroid Treatment in Patients with Sudden Hearing Loss.
- Conditions
- 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.Therapeutic area: Diseases [C] - Ear, nose and throat diseases [C09]
- Registration Number
- EUCTR2021-004323-33-CZ
- Lead Sponsor
- AudioCure Pharma GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- 210
1. Signed Institutional Review Board (IRB) / Independent Ethics
Committee (IEC) approved informed consent form (ICF)
2. Female or male patients aged between 18 and 85 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 30 dB compared to the current audiogram of the non-affected ear (average of the three most affected consecutive frequencies between 0.25 and 8 kHz).
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:
o 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
o 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:
o Patient is unable to procreate, defined as surgically sterile (i.e. has undergone a vasectomy at last 6 months before Screening)
o 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
1. Insufficient handling of the language used in the speech audiometry tests
2.
a) Bilateral 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). Only if the limit for bone conduction is reached, tympanogram type can be used (other than A).
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 1 year in the affected ear
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. Medical History of one of the following diseases:
oHuman immunodeficiency virus (HIV), hepatitis B, or hepatitis C infection
oSystemic mycosis and parasitosis (amoebic or worm infections)
oAcute and chronic bacterial infections
oTuberculosis
oSevere osteoporosis
oNarrow and wide-angle glaucoma, corneal ulceration and corneal injury
oSevere ulcerative colitis with impending perforation, with abscesses or purulent inflammations
oExercise-induced angina, known class III or IV heart failure, as defined by the New York Heart
association (NYHA) functional classification system
oGastric or duodenal ulcer, existing or treated within <1 year prior to randomization
oMyasthenia gravis
oPatients with diagnosed anxiety disorders, psychosis, depression, schizophrenia, suicidal ideation or other significant psychiatric conditions. Inclusion only after critical evaluation by the Investigator
16.Uncontrolled systolic (>180 mmHg) or diastolic (>100 mmHg) blood pressure at Screening
17.Difficult to control diabetes
18.Treatment with medication listed in 4.4 of the protocol
19.Patients who have answered yes to questions 4 or 5 of the CSSRS
20.Hypersensitivity to prednisolone
21.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
22.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
23.Patients who are involved in the organization of the clinical investigation or are in any way dependent on the Investigator or Sponsor
24.Major surgery within eight weeks before Screening or scheduled/planned surgery within the time frame of the study
25.Medical reasons which, in the opinion of the Investigator, preclude inclusion in the study
26.Legal incapacity or limited legal capacity
27.Patients who have been committed to an institution by v
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method