Clinical trial: SPI-1005 for the Treatment of Patients With Meniere's Disease (NCT03325790)

Eligibility criteria:
Inclusion Criteria:

          -  Adult male and female patients, 18-75 years of age at the time of enrollment.

          -  Diagnosis of probable or definitive Meniere's disease by American Academy of
             Otolaryngology-Head and Neck Surgery (AAO-HNS) 1995 criteria.

          -  Two of three active symptoms including vertigo or disequilibrium, fluctuating hearing
             loss, or tinnitus within the 3 months prior to study enrollment.

          -  Hearing loss of ≥ 30 decibels (dBHL) at either 250, 500 or 1000 Hz.

          -  Voluntary consent to participate in the study.

          -  Male subjects that are willing to use condoms throughout the study period and 90-days
             following study completion even if not fertile.

          -  Females of childbearing potential should either be sexually inactive (abstinent) for
             14 days prior to screening and throughout the study or be using one of the following
             acceptable birth control methods:

               -  Intrauterine Device in place for at least 3 months prior to study; 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 and through
                  study completion; or

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

          -  Females of non-childbearing potential should be surgically sterile (bilateral tubal
             ligation with surgery at least 6 months prior to study enrollment, hysterectomy, or
             bilateral oophorectomy at least 2 months prior to study) or be at least 1 year since
             last menses.

        Exclusion Criteria:

          -  Current use of or within 60 days prior to study IV ototoxic medications such as
             chemotherapy including cisplatin, carboplatinum, or oxaliplatin; aminoglycoside
             antibiotics including gentamicin, amikacin, tobramycin, kanamycin, or streptomycin; or
             loop diuretics including furosemide.

          -  History of otosclerosis or vestibular schwannoma.

          -  History of significant middle ear or inner ear surgery.

          -  Current conductive hearing loss, otitis media, or mixed hearing loss.

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

          -  Current use or within 30 days prior to study enrollment systemic steroids or drugs
             known to be strong inhibitors or inducers of cytochrome P450 enzymes.

          -  Hypersensitivity or idiosyncratic reaction to compounds related to ebselen or
             selenium.

          -  Female patients who are pregnant or breastfeeding.

          -  Participation in another interventional drug or device study within 30 days prior to
             study consent.
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? 1