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
This research study is investigating a new treatment called AC102 for people who experience sudden hearing loss. It's a 'Phase II' study, which means it’s still in the early stages, looking to see if the treatment is effective and safe. We're comparing AC102, which is given as a single injection directly into the ear, with steroid tablets (Prednisolone), a common treatment for this condition. We want to find out how well each treatment helps to improve hearing over time and to make sure they are well-tolerated. The main goal is to see if AC102 can help people hear better after 28 days.
At a glance
What is this study about?
This research is looking for better ways to treat sudden hearing loss, which is when you lose your hearing very quickly, usually in one ear, for no clear reason. Doctors call this 'Idiopathic Sudden Sensorineural Hearing Loss'. It can be a very worrying experience, and currently, steroid tablets are often used to try and help.
In this study, called ACUTEC, we are testing a new treatment called AC102. This new treatment is given as a single injection directly into the affected ear. We want to see how it compares to taking steroid tablets by mouth, which is a common way to treat this condition. The study aims to find out if AC102 is effective at improving hearing, how safe it is, and if people can tolerate it well.
The main thing we're looking at is how much hearing improves on average after 28 days of treatment. We'll also be checking how well people can understand speech, their hearing levels over a longer period (up to 84 days), and if they need a hearing aid or if their quality of life improves. This kind of study helps doctors understand if new treatments could be helpful for future patients.
Key takeaways
- The study is testing a new ear injection, AC102, for sudden hearing loss.
- It compares AC102 to standard steroid tablets.
- The main goal is to see if hearing improves after 4 weeks.
- Participation involves clinic visits and hearing checks over 12 weeks.
- You might receive the new drug, steroids, or an inactive treatment.
Who may be eligible?
To join this study, you must be at least 18 years old. Both men and women are welcome to take part. The study is specifically for people who have recently experienced 'Idiopathic Sudden Sensorineural Hearing Loss' – that's when you've had a sudden loss of hearing in one ear without a clear cause.
There will be other specific medical checks to make sure the study is right for you, for your safety and to ensure the results are accurate. These checks will be explained by the study team, and they will make sure you fit all the necessary requirements before you can join. It's important to discuss your full medical history with them.
- Are you 18 years old or older?
- Have you recently experienced sudden hearing loss in one ear?
- Are you able to attend several clinic appointments over 12 weeks?
- Are you comfortable with the idea of a single ear injection or taking tablets?
- Are you willing to potentially receive an inactive treatment (placebo)?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part in this study, you will be in the study for about 12 weeks (84 days) in total. During this time, you'll have several visits to the clinic. At these visits, you will have hearing tests to measure your hearing levels, especially speech recognition. You might also fill out questionnaires about how your hearing loss affects your daily life.
The study treatment involves either receiving a single injection of AC102 into your ear, or taking steroid tablets, or receiving a 'dummy' treatment (placebo gel or dummy tablets). Which treatment you receive will be decided by chance, and neither you nor your study doctor will know which one you are getting. This is to make sure the results are fair. We will check your hearing at several points, including on days 14, 28, 56, and 84 after you start the treatment.
Potential risks and benefits
Locations (5)
- —Poland
- —Czechia
- —Germany
- —Austria
- —Netherlands
Common questions
What is 'sudden hearing loss'?
It's when you suddenly lose hearing, usually in one ear, often without knowing why.
What is AC102?
AC102 is a new liquid medicine that is given as an injection directly into the ear to treat sudden hearing loss.
Will I know if I'm getting the new drug or standard treatment?
No, neither you nor your doctor will know which treatment you are getting; this is to ensure fair results.
How long will I be in the study?
You will be watched and tested for about 12 weeks, or 84 days, after you start treatment.
Can I leave the study early?
Yes, you can choose to leave the study at any time without giving a reason, and it won't affect your care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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