Clinical Trial OTO-104

A clinical trial of a new investigational drug for vertigo in Ménière’s disease - OTO-104

By:  The OTO-104 Study Team

What is a clinical trial?

Clinical trials help scientists and doctors explore whether a medical strategy, treatment, or device is safe and effective for humans.  Information obtained during this trial may be useful scientifically and therefore may be helpful to people with Meniere’s disease in the future.  It is not known if the Investigational Product (IP) or placebo will help your condition.

What is the purpose of this trial?

The purpose of this trial is to determine the safety and effectiveness of the investigational product on vertigo episodes (spinning feeling) in patients with Meniere’s disease.

Why participate?

Your participation in this trial may help researchers learn more about Meniere’s disease and potentially find a treatment option for patients with Meniere’s disease in the future.

Meniere’s disease is a disorder of the inner ear that causes episodes in which you feel like you are spinning (vertigo) and have fluctuating hearing loss, ringing in the ear (tinnitus), and ear fullness or pressure. The cause of Meniere’s disease is not fully understood, but one popular theory is that Meniere’s disease is the result of an abnormal amount of fluid in the inner ear. Currently, there is no cure for the disease.  Available treatment tends to focus on relieving the vertigo symptoms, but these treatments can be ineffective. It is important that researchers continue to trial more effective alternatives for Meniere’s disease.

Who can join?

You may be able to join the trial if you meet these criteria*:

- 18 to 85 years of age

- Have been diagnosed with Meniere’s disease in one ear

- Have had spinning (vertigo) episodes for 2 months before joining the trial

*Other criteria will apply.

What is the investigational product?

The investigational product is given as a single injection into the middle ear through the eardrum. It is considered “investigational” because it has not been approved by the United States Food and Drug Administration (FDA) or another regulatory authority for treating Meniere’s disease. The investigational product is being developed in hopes that it may relieve vertigo symptoms.

This active investigational product will be compared to placebo, which is also given as an injection, but it has no active ingredients.

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 period.

- During the lead-in period, you will record your daily vertigo experiences by telephone in a trial diary.

- If you complete your diary entries during the lead-in period and qualify to participate, you will be randomly assigned (like by the flip of a coin), with a 50/50 chance, to receive either a single injection of the active Investigational Product or placebo.

- After your injection, you will continue to record your daily vertigo experiences. You will visit the trial clinic at Weeks 4 and 8, and you will receive assessments to measure the effectiveness and monitor the safety of the Investigational Product or placebo. You will have a final visit at Week 12.

Where and when is it taking place?

The study is underway now and is taking place at the following clinical research centres and hospitals in the UK:
 
Ninewells Hospital and Medical School
Dundee, Angus, United Kingdom, DD1 9SY 
Contact: P Spielmann, (+44) 0138 2633899, patrickspielmann@nhs.net
    
Royal Victoria Hospital
Belfast, United Kingdom, BT12 6BA 
Contact: Neil Bailie, Neila.Bailie@belfasttrust.hscni.net
    
Cambridge University Hospitals NHS Foundation Trust
Cambridge, United Kingdom, CB2 0QQ 
Contact: Neil Donnelly, (+44) 012 2358 6638, neil.donnelly@addenbrookes.nhs.uk
    
University Hospital of Wales
Cardiff, United Kingdom, CF14 4XW 
Contact: Julia Dolby, (+44) 029 2074 3174, julia.dolby@wales.nhs.uk
    
Gloucestershire Royal Hospital
Gloucester, United Kingdom, GL1 3NN 
Contact: Matthew Clark, matthew.clark11@nhs.net
    
University Hospitals of Leicester NHS Trust, Leicester Royal Infirmary
Leicester, United Kingdom, LE1 5WW 
Contact: Adam Lewszuk, (+44)011 6258 5973, clinical.research@uhl-tr.nhs.uk
    
Guy's and St Thomas' NHS Foundation Trust
London, United Kingdom, SE1 9RT 
Contact: Abigail Tetteh, ENTResearch@gstt.nhs.uk
    
Manchester Head and Neck Centre, Peter Mount Building
Manchester, United Kingdom, M13 9WL 
Contact: Alice Panes, (+44) 0161 701 1262, alice.panes@mft.nhs.uk  
 
Norfolk & Norwich University Hospital
Norwich, United Kingdom, NR4 7UY 
Contact: Catherine Wright, (+44) 016 0364 6108, catherine.wright@nnuh.nhs.uk
    
The Royal Hallamshire Hospital
Sheffield, United Kingdom, S10 2JF 
Contact: Jayne Wilson, (+44) 0114 271339, jayne.willson@sth.nhs.uk
 
More information
If you are interested in taking part in the study and would like to receive further information, please contact the hospital or research centre noted above that’s located closest to you.

To find out more about clinical trials, please visit:  https://bepartofresearch.nihr.ac.uk/

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