Clinical trial: OTO-104 for Meniere's Disease (NCT01084525)

Eligibility criteria:
Inclusion Criteria:

          1. Subject has a diagnosis of unilateral Meniere's disease by 1995 American Academy of
             Otolaryngology - Head and Neck Surgery (AAOHNS) criteria and reports active vertigo
             for the 2 months prior to the study lead-in period.

          2. Subject has experienced active vertigo during the lead-in period.

          3. Subject has asymmetric low frequency sensorineural hearing loss.

          4. Subject agrees to maintain their current treatments for Meniere's disease while
             on-study.

          5. Subjects not currently on a low-salt diet or diuretic should have a medical history of
             having used one or both of these treatments for at least 1 month without relief of
             symptoms.

          6. Subjects currently on a low-salt diet and/or diuretic at the time of screening agree
             to continue this treatment throughout the study.

        Exclusion Criteria:

          1. Subject has an infection in the ear, sinuses, or upper respiratory system.

          2. Subject is pregnant or lactating.

          3. Subject has a history of immunodeficiency disease.

          4. Subject has a history of previous endolymphatic sac surgery.

          5. Subject has a history of previous use of intratympanic (IT) gentamicin in the affected
             ear.

          6. Subject has a history of tympanostomy tubes with evidence of perforation or lack of
             closure.

          7. Subject has experienced an adverse reaction to IT injection of steroids.

          8. Subject has used an investigational drug or device in the 3 months prior to screening.

          9. Subject has had a duration of Meniere's disease of >20 years.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 75 Years

Patient description (medical language): A 47-year-old woman comes to the clinic complaining of dizziness.  She also has occasional nausea and ringing in her right ear.  The patient also has difficulty hearing while holding her phone to the left ear, although hearing in her right ear is normal.  The dizziness improves spontaneously, and she feels fine between episodes.  Past medical history is notable for hypothyroidism and low vit D level, for which she is using Levothyroxine and Vit D pearl.  She does not use tobacco or drink alcohol. Physical examination shows sensorineural hearing loss in the left ear. She has only one-man sexual partner and menopaused 2 years ago.

Patient description (patient's own words): The other day, I had to go to the clinic due to severe dizziness. I'm 47 years old, and I've been suffering from nausea and ringing in my right ear. I also have difficulty hearing in my left ear while I hold my phone, even if my hearing in my right ear is normal. The dizziness just gets me all of a sudden but I don't have any symptoms in between 2 episodes. I suffer from hypothyroidism and low vitamin D levels. So I take Levothyrox and vitamin D pearl. I don't smoke or drink. They conducted a physical exam and said I had hearing loss in my left ear. My only partner is my husband, and I'm menopause for 2 years now.

Does the patient match the trial criteria? Entailment