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.

Phase 2

Recruiting

• Conditions: Idiopatic Sudden Sensorineural Hearing loss; Sudden Hearing loss; 10019243

• Registration Number: NL-OMON56096
• Lead Sponsor: Audiocure Pharma GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 20

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 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
(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 attend the trial visits
8. 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)
9. 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

Exclusion Criteria

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:
o Human immunodeficiency virus (HIV), hepatitis B, or hepatitis C infection
o Systemic mycosis and parasitosis (amoebic or worm infections)
o Acute and chronic bacterial infections
o Tuberculosis
o Severe osteoporosis
o Narrow and wide-angle glaucoma, corneal ulceration and corneal
injury
o Severe ulcerative colitis with impending perforation, with abscesses or
purulent inflammations
o Exercise-induced angina, known class III or IV heart failure, as defined by
the New York Heart Association (NYHA) functional classification system
o Gastric or duodenal ulcer, existing or treated within <1 year prior to
randomization
o Myasthenia gravis
o Patients 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 C-SSRS
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
2

Study & Design

• Study Type: Interventional
• Study Design: Not specified