SPI-1005 for the Treatment of Patients With Meniere's Disease
Condition: Meniere's Disease
MeSH terms: Meniere Disease
Intervention: 200mg SPI-1005 BID; 400mg SPI-1005 BID; Placebo
Intervention description: Active: low dose; Active: high dose; Placebo Comparator
Intervention MeSH terms: Ebselen
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: DOUBLE-BLIND
Enrollment: 149.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Meniere's disease; Hearing Loss; Vertigo; Tinnitus; Ebselen; Pharmacokinetics; Safety; Efficacy; Speech

Summary:

      This study will evaluate the safety, efficacy, and Pharmacokinetics (PK) of two dose levels
      of SPI-1005 administered for 28 days compared to placebo in patients with Meniere's disease.
    

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, carboplatin, 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.