This section is designed for patients who are interested in participating in the REGAIN trial.
A drug is in development that may be able to restore hearing loss. The REGAIN study aims to test how safe the drug is and if it affects the ability to hear The REGAIN trial is currently open to participants in the UK that are able to travel to the Royal National Throat Nose and Ear Hospital in London. Compensation for your time and travel will be provided.
We hope that you find the information you are looking for here on the website. If you are interested in taking part, please contact the REGAIN team using the contact details at the bottom of this page.
The aim of this study is to test a new drug that may be able to treat sensorineural hearing loss. This is the most common form of hearing loss. It can be caused by damage to the hair cells lining the inner ear. When sound waves enter the inner ear, the hair cells move, which sends a signal to the nerve that runs from the ear to the brain. The brain recognises these signals as sounds.
Up until now, damage to the inner ear hair cells has been considered irreversible. Once hair cells become damaged, they will remain damaged throughout a person’s life. Hearing aids can be used for people with hearing loss to amplify sounds to make it easier for damaged hair cells to detect them but there is currently no cure. Recently, scientists have made discoveries, which show that it is possible to regrow hair cells, and potentially restore hearing loss, using a drug known as a gamma secretase inhibitor.
The study drug, a gamma secretase inhibitor, is a small chemical compound that may help supporting cells in the inner ear to develop into new hair cells. It has been tested in animals in which it was found to be safe at the doses given. This is the first time the study drug LY3056480 will be tested in people. The study drug is a liquid that must be delivered to the inner ear, through the eardrum using a syringe. This technique is commonly used to deliver other drugs, such as corticosteroids, inside the ear, for example for the treatment of Meniere’s Disease. Each participant will receive an injection in one ear, three times in total by an experienced Ear Nose and Throat surgeon. The same ear will be treated during the study. This will be the ear most affected by your hearing loss. If you feel there is no difference, the study doctor will decide which ear to treat.
This safety study is designed to test 4 dose levels of the study drug. A minimum of three people will receive each dose. Every participant will receive the drug. This is an open-label study, which means that both you and the research team will know which dose you are given.
You may be eligible if:
For further information, please contact the REGAIN study team:
Telephone: 0203 108 9344
or complete the contact form on your right.