Could a new drug quiet the ringing and dizziness of Meniere's disease?
NCT ID NCT02603081
First seen Jun 29, 2026 · Last updated Jun 30, 2026 · Updated 1 time
Summary
This study tests an experimental drug called SPI-1005 (ebselen) in adults with Meniere's disease, a condition that causes vertigo, tinnitus, and hearing loss. The trial compares three doses of SPI-1005 against a placebo to see if it safely reduces these symptoms. Researchers will monitor side effects, drug levels in the blood, and changes in hearing and balance over several weeks.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- SPI-1005 (ebselen)
- What this could lead to
- If successful, SPI-1005 could offer a new treatment option to reduce vertigo attacks and hearing loss in people with Meniere's disease.
- What could go wrong
- This is an early-phase trial with only 40 participants, so results may not apply to everyone. The drug's safety and effectiveness are still unproven.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
-
40 people
The number who actually took part.
- Start date
-
Dec 2015
- Finished
-
Aug 2017
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
19 to 70 years
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
House Clinic
Los Angeles, California, 90057, United States
-
MUSC
Charleston, South Carolina, 29425, United States
-
New York Otology
New York, New York, 10028, United States
-
Northwest Ear
Seattle, Washington, 98104, United States
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Sound Pharmaceuticals, Inc.
Seattle, Washington, 98103, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Wearable eye-tracker aims to catch dizziness in the act
- New MRI scan could diagnose Meniere's disease without needle dye
- New hope for hearing loss? drug targets inner ear inflammation
- Scientists hunt for genetic clues to Menière's disease
- Scientists dive deep into mysterious hearing fluctuations
- Hope for Meniere's sufferers: new drug enters final testing phase