Meniere’s Disease Clinical Trial at the Ear Institute and Icahn School of Medicine
Researchers at the Ear Institute at New York Eye and Ear Infirmary of Mount Sinai and the Icahn School of Medicine at Mount Sinai, along with Otonomy, are investigating the efficacy of a new Investigational Product, aimed at minimizing vertigo episodes in patient with Meniere’s disease. This treatment is administered as a single injection into the middle ear. It is considered “investigational,” as it has not yet been approved by the U.S. Food and Drug Administration (FDA) for treating Meniere’s disease.
Why Participate in this Meniere’s Disease Trial?
You or your loved one’s participation in this trial will help researchers learn more about Meniere’s disease and how to treat it in the future. The cause of this condition is not fully understood, but it is widely believed to be the result of an abnormal amount of fluid in the inner ear.
Currently, no cure exists for this disease. Available treatments tend to focus on relieving the vertigo (spinning) symptoms, but are not necessarily addressing the disorder as a whole. It is imperative that researchers continue investigating effective alternatives for current and future Meniere’s disease patients.
Who Is Eligible to Participate in the Study?
If you are interested in participating in this study and meet the criteria listed below, please email your contact information to firstname.lastname@example.org. One of our senior research coordinators will contact you to discuss enrollment in the study. To join the trial, participants must:
- Be between 18 and 85 years old
- Have been diagnosed with Meniere’s disease in one ear
- Have had vertigo episodes for two months prior to joining the trial
- Have no history of middle or inner ear surgery
Other criteria may apply.
What Can Trial Participants Expect?
If you are eligible and agree to join the trial, your participation will last about 16 weeks, including a 4-week lead-in period and a 12-week follow-up duration. Some highlights of participant activities are:
- During the lead-in period, participants will record their daily vertigo experiences by telephone in a trial diary.
- Upon completion of the diary entries during the lead-in time, participants will be randomly assigned (50/50 chance) to receive either a single injection of the active Investigational Product or placebo, which will have no active ingredients.
- After the injection, participants will continue to record their daily vertigo experiences. They will visit the trial facility at Weeks 4 and 8, and receive assessments to measure the effectiveness. Throughout this time, researchers will be monitoring the safety of the Product.
- Participants will have one final visit during Week 12.
Thank you for your interest and shared aim of effectively treating Meniere’s disease in the future.