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

      A clinical study team are looking for volunteers to test their new investigational drug, OTO-104, for vertigo episodes in Ménière’s disease.

      By: The OTO-104 Study Team | 11 March 2020

      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 Ménière’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 Ménière’s disease.

      Why participate?


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

      Ménière’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 Ménière’s disease is not fully understood, but one popular theory is that Ménière’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 Ménière’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 Ménière’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 Ménière’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/
      A clinical trial of a new investigational drug for vertigo in Ménière’s disease

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