In short
This article discusses a clinical trial investigating the use of AC102, a new drug containing 6-Fluoro-9-Methyl-9H-Pyrido[3,4-B]-Indole, for treating idiopathic sudden sensorineural hearing loss (ISSNHL). The study compares a single intratympanic injection of AC102 to traditional oral steroid treatment, focusing on efficacy, safety, and tolerability in patients with moderately-severe to profound ISSNHL.
At a glance
- Study Type
- Phase II, Multi-Center, Randomized, Blinded
- Condition
- Idiopathic Sudden Sensorineural Hearing Loss (ISSNHL)
- Intervention
- Single intratympanic dose of AC102 vs. oral steroids
- Primary Outcome
- Hearing threshold improvement from baseline to Day 28
- Key Inclusion Criteria
- Age 18-85, unilateral ISSNHL, onset 24-120 hours before randomization
- Key Exclusion Criteria
- History of certain ear diseases, severe systemic conditions, recent ISSNHL
- Study Duration
- Up to 84 days per participant
What is AC102?
AC102 is a new medication being studied for the treatment of sudden hearing loss. Its active ingredient is 6-fluoro-9-methyl-9h-pyrido[3,4-b]-indole, a chemical compound that may help improve hearing in patients with this condition. AC102 is currently being developed by AudioCure Pharma GmbH and is considered an orphan drug, which means it's intended to treat a rare medical condition.
What condition does AC102 treat?
AC102 is being investigated as a treatment for Idiopathic Sudden Sensorineural Hearing Loss (ISSNHL). This is a condition where a person experiences a rapid and unexplained loss of hearing, typically in one ear. The term "idiopathic" means that the cause is unknown, "sudden" indicates that it occurs rapidly (usually within 72 hours), and "sensorineural" refers to the type of hearing loss, which involves the inner ear or auditory nerve.
How is AC102 administered?
AC102 is administered as a single intratympanic injection. This means the medication is injected directly into the middle ear. The drug comes in the form of a gel for injection, with a concentration of 12 mg/ml. The maximum dose used in the study is 0.8 ml, given as a single treatment.
Clinical Trial Details
A Phase II clinical trial is currently underway to evaluate the effectiveness and safety of AC102. This study is: Multi-center: Conducted at multiple medical facilities Randomized: Participants are randomly assigned to either receive AC102 or the standard treatment (oral steroids) Blinded: Participants and some study staff don't know which treatment each person is receiving The main goal of this trial is to compare the effectiveness of a single dose of AC102 to oral steroids in patients with moderately-severe to profound ISSNHL.
Potential Benefits
The study aims to determine if AC102 can provide benefits such as: Improvement in hearing threshold (how quiet a sound can be for a person to hear it) Better speech recognition Improved quality of life related to hearing Reduced need for hearing aids or cochlear implants These potential benefits will be assessed over a period of 84 days (about 3 months) after treatment.
Eligibility Criteria
To participate in this study, patients must meet certain criteria, including: Age between 18 and 85 years Sudden hearing loss in one ear only, occurring within 24 to 120 hours before starting the study Significant hearing loss (at least 65 dB in the affected ear) No history of certain medical conditions that could affect hearing or treatment safety It's important to note that there are many other specific inclusion and exclusion criteria that a healthcare provider would need to review.
Safety Considerations
As with any medical treatment, safety is a key concern. The study will carefully monitor participants for any side effects or adverse reactions. Some patients may not be eligible for the study if they have certain medical conditions or are taking specific medications that could interfere with the treatment or increase risks.
It's important to remember that AC102 is still an experimental treatment. While it shows promise, its effectiveness and safety are still being evaluated. Patients experiencing sudden hearing loss should consult with their healthcare provider to discuss the best treatment options for their individual situation.