BridgeMD
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.
EU CTIS ID: 2024-513658-31-00
What this study is testing
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.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Signed Institutional Review Board (IRB) / Independent Ethics Committee (IEC) approved informed consent form (ICF)
- Female or male patients aged between 18 and 85 years (inclusive) at the day of Screening
- Unilateral ISSNHL
- Onset of unilateral ISSNHL between 24 to 120 hours prior to randomization
- 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)
- 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).
You likely can't join if
- Insufficient handling of the language used in the speech audiometry tests
- History of ISSNHL in the past 1 year in the affected ear.
- History of radiation-induced hearing loss, fluctuating hearing, endolymphatic hydrops or Menière’s disease in either ear
- History of chronic inflammatory or chronic suppurative ear disease or cholesteatoma in the affected ear
- History of otosclerosis in the affected ear
- Family history of hearing impairment other than age-related
See the full eligibility criteria
Who can join
- Signed Institutional Review Board (IRB) / Independent Ethics Committee (IEC) approved informed consent form (ICF)
- Female or male patients aged between 18 and 85 years (inclusive) at the day of Screening
- Unilateral ISSNHL
- Onset of unilateral ISSNHL between 24 to 120 hours prior to randomization
- 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)
- 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).
- Willing and able to attend the trial visits
- 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).
- 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
What rules you out
- Insufficient handling of the language used in the speech audiometry tests
- History of ISSNHL in the past 1 year in the affected ear.
- History of radiation-induced hearing loss, fluctuating hearing, endolymphatic hydrops or Menière’s disease in either ear
- History of chronic inflammatory or chronic suppurative ear disease or cholesteatoma in the affected ear
- History of otosclerosis in the affected ear
- Family history of hearing impairment other than age-related
- If one of the following diseases is known: - Active disease and/or confirmed infection with immunodeficiency virus (HIV),- Active hepatitis B or hepatitis C virus infection; - Systemic mycosis and parasitosis (amoebic or worm infections) ; - Acute and chronic bacterial infections; -History of or active tubercolosis; - 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 <1 year prior to randomization; -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
- Uncontrolled systolic (>180 mmHg) or diastolic (>100 mmHg) blood pressure at Screening
- Difficult to control diabetes
- Treatment with medication listed in 4.4 of the protocol
- Patients who have answered “yes” to questions 4 or 5 of the C-SSRS
- 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)
- Hypersensitivity to prednisolone
- 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
- 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
- Patients who are involved in the organization of the clinical investigation or are in any way dependent on the Investigator or Sponsor
- Major surgery within eight weeks before Screening or scheduled/planned surgery within the time frame of the study
- Medical reasons which, in the opinion of the Investigator, preclude inclusion in the study
- Legal incapacity or limited legal capacity
- Patients who have been committed to an institution by virtue of an order issued either by the judicial or the administrative authorities
- 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). Only if the limit for bone conduction is reached, tympanogram type can be used (other than A).
- Suspected perilymph fistula or round window membrane rupture in either ear
- Otitis media or otitis externa that is ongoing or ended within 30 days prior to randomization or is occurring several times per year
- Patients with abnormality of the tympanic membrane or the outer ear canal that would preclude intratympanic administration
- Evidence or history of vestibular schwannoma (acoustic neuroma) or other retrocochlear damage in the affected ear
The study team makes the final eligibility decision.
Where it's taking place
- Serbia
- Ukraine
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Serbia; Ukraine. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.