What is the purpose of this study?

This study wants to test the effectiveness of AM-111 when used to treat acute hearing loss. It also wants to learn more about the safety of AM-111 and how well it is tolerated. Currently, there is no approved treatment available that cures acute hearing loss.

AM-111 is a gel that is injected through the eardrum, directly into the middle ear space. In this study, two doses of AM-111 will be compared against placebo. The placebo looks like AM-111, but does not contain any active medication.

You will be randomly assigned by chance (like the flipping of a coin) to one of the following treatment groups:

  • Low-dose AM-111
  • Higher-dose AM-111
  • Placebo.

There is a 2 in 3 (66%) chance that you will receive AM-111, and a 1 in 3 (33%) chance that you will receive placebo. You will receive one injection of AM-111 or placebo in your affected ear.
AM-111 is an investigational product, which means it is still being studied to find out if it works in the treatment of sudden hearing loss.  AM-111 is not approved for sale in your country or any other country, and may only be used in research studies like this one. You may have the option for your study doctor to prescribe a corticosteroid therapy (for instance, prednisolone) as background therapy which is considered standard of care.

AM-111 has been developed to protect hearing cells and nerves following acute hearing loss. For AM-111 to be effective, it must be administered as soon as possible after the occurrence of acute hearing loss. This helps protect the damaged cells, which can then recover and continue carrying out their function. In previous studies, AM-111 showed effectiveness in patients with severe to profound hearing loss and was found to be very well-tolerated.

The following individuals are eligible for our clinical trial:

  • those who are older than 18,
  • those who have hearing loss that started no more than 72 hours prior to treatment,
  • not have had hearing loss from noise, air pressure change or head trauma,
  • for females: not pregnant or breastfeeding.

Before you can take part in the trial, a study doctor will carry out procedures to check if you are eligible to participate. If your hearing loss started more than 72 hours ago, we advise you consult your local ear specialist or primary care doctor.