Hearing Restoration Clinical Trial NCT02132130
Novartis Pharmaceuticals is sponsoring a gene therapy clinical research trial for women and men between the ages of 18 to 75 years old with severe hearing loss in one or both of their ears. The purpose of this study is to evaluate the safety, tolerability, and the potential ability of a new gene therapy to improve hearing. In the study, the drug will be initially administered to the inner ear using a surgical procedure. The study therapy is expected to help existing cells in the inner ear change to become new and functioning sensory hair cells.
The first two parts of this study have been completed, patients are now being actively recruited for the third and final part. In this part of the study, patients will receive the highest dose of the study drug that was declared safe and tolerable in the first two parts of the study.
To learn more about hearing loss, click here.
To see if you may be eligible, click here for a pre-screener/questionnaire.
Find out if there is a clinical study location nearby.
Patients who wish to participate in this trial must meet the following requirements:
- Must be between 18 to 75 years old
- Must weigh at least 89 pounds (40 kilograms)
- Must have severe-to-profound hearing loss in one or both ears with intact vestibular function
- Must have had an MRI scan within six months or at screening to confirm suitability for inner ear surgery
- Cannot have hearing loss due to a genetic or developmental disorder
- Cannot have cochlear implants or a past cochlear implant in the study ear
- Cannot have had previous surgery on the study ear
- Cannot have a history of radiation therapy to the head and neck
- Cannot have any past serious adverse reactions to anesthesia
- Cannot be pregnant or nursing
Patients who are eligible and decide to enroll in this trial:
- Will not be charged to participate
- Will receive compensation for time and travel costs
- May withdraw from the trial at any time, for any reason.
Additional study locations may be listed as they open in the future. We encourage you to share this information via the links at the top of the page.