Study to Evaluate SPI-1005 in Adults With Meniere's Disease

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Meniere's Disease

In brief

This study will evaluate the safety and efficacy of three dose levels of SPI-1005 compared to placebo on vertigo, tinnitus and sensorineural hearing loss in 40 adults with Meniere's disease.

Key facts

Study ID

NCT02603081

Run by

Sound Pharmaceuticals, Incorporated

People needed

40

Starts

2015-12-01

Expected to finish

2017-08-01

Last updated by the study team

2026-06-29

Who can join

Age: 19 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• House Clinic — Los Angeles, California, United States
• New York Otology — New York, New York, United States
• MUSC — Charleston, South Carolina, United States
• Sound Pharmaceuticals, Inc. — Seattle, Washington, United States
• Northwest Ear — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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