Clinical trial: Study to Evaluate SPI-1005 in Adults With Meniere's Disease (NCT02603081)

Eligibility criteria:
Inclusion Criteria:

          -  Diagnosis of probable or definite Meniere's Disease by AAO-HNS 1995 criteria within 12
             months of study enrollment;

          -  Voluntarily consent to participate in the study;

          -  Females of childbearing potential should be using and committed to continue using one
             of the following acceptable birth control methods:

               -  Sexual abstinence (inactivity) for 14 days prior to screening through study
                  completion; or

               -  IUD in place for at least 3 months prior to study through study completion; or

               -  Barrier method (condom or diaphragm) with spermicide for at least 14 days prior
                  to screening through study completion; or

               -  Stable hormonal contraceptive for at least 3 months prior to study through study
                  completion; or

               -  Surgical sterilization (vasectomy) of partner at least 6 months prior to study.

          -  Females of non-childbearing potential should be surgically sterile (bilateral tubal
             ligation with surgery at least 6 months prior to study, hysterectomy, or bilateral
             oophorectomy at least 2 months prior to study) or be at least 3 years since last
             menses.

        Exclusion Criteria:

          -  Current use or within 90 days prior to study of ototoxic medications such as
             aminoglycoside antibiotics (gentamicin, tobramycin, amikacin, streptomycin);
             platinum-containing chemotherapies (cisplatin, carboplatin, oxaliplatin); or loop
             diuretic (furosemide);

          -  History of idiopathic sensorineural hearing loss, otosclerosis, or vestibular
             schwannoma;

          -  History of middle ear or inner ear surgery;

          -  Current conductive hearing loss or middle ear effusion;

          -  Significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal,
             endocrine, immunologic, or psychiatric disease;

          -  History of hypersensitivity or idiosyncratic reaction to compounds related to ebselen;

          -  Current use or within 30 days prior to study of drugs or substances known to be strong
             inhibitors or inducers of cytochrome P450 enzymes;

          -  Participation in another investigational drug or device study within 90 days prior to
             study enrollment;

          -  Female patients who are pregnant or breastfeeding.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 19 Years old.
Subject must be at most 70 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? 1