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6-Fluoro-9-Methyl-9H-Pyrido[3,4-B]-Indole

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.

Table of Contents

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[1].

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[1].

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[1].

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[1].

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[1].

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[1].

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[1].

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.

Aspect Details
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

FAQ

  • What is the main purpose of this clinical trial? The main purpose is to evaluate the effectiveness of a single dose of AC102 injected into the middle ear compared to oral steroids for treating sudden hearing loss.
  • Who can participate in this study? Participants must be between 18 and 85 years old, have unilateral ISSNHL that started 24 to 120 hours before the study, and meet specific hearing loss criteria.
  • How is AC102 administered in this trial? AC102 is administered as a single intratympanic injection, which means it's injected directly into the middle ear.
  • What are the main outcomes being measured? The primary outcome is the improvement in hearing threshold from baseline to Day 28. Secondary outcomes include long-term hearing improvement, speech recognition, and quality of life measures.
  • How long does the study last for each participant? The study follows participants for up to 84 days (about 12 weeks) to assess long-term effects of the treatment.

Ongoing Clinical Trials on 6-Fluoro-9-Methyl-9H-Pyrido[3,4-B]-Indole

  • Study on the Effectiveness and Safety of AC102 Injection vs. Oral Prednisolone for Patients with Sudden Hearing Loss

    Not recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    Austria Czechia Germany The Netherlands Poland

Glossary

  • Idiopathic Sudden Sensorineural Hearing Loss (ISSNHL): A rapid loss of hearing in one ear with no known cause, typically affecting the inner ear or neural pathways.
  • Intratympanic: Referring to a procedure or medication administered into the middle ear space.
  • Pure Tone Audiometry (PTA): A hearing test that measures the softest sounds a person can hear at different pitches or frequencies.
  • Speech Recognition: The ability to understand spoken words, often tested as part of hearing assessments.
  • Tympanic Membrane: Also known as the eardrum, it's a thin membrane that separates the outer ear from the middle ear.
  • Conductive Hearing Loss: Hearing loss caused by problems in the outer or middle ear that prevent sound from reaching the inner ear effectively.
  • Sensorineural Hearing Loss: Hearing loss caused by damage to the inner ear or the nerve pathways from the inner ear to the brain.
  • Cochlear Implant: An electronic device that can help provide a sense of sound to a person with severe hearing loss.
  • Hearing Handicap Inventory (HHIA): A questionnaire used to assess how hearing loss affects a person's daily life and emotional well-being.

References

  1. http://clinicaltrials.eu/trial/study-on-the-effectiveness-and-safety-of-ac102-injection-vs-oral-prednisolone-for-patients-with-sudden-hearing-loss/