Meniere's DiseasePhase 1/2NCT02603081
Study to Evaluate SPI-1005 in Adults With Meniere's Disease
A Phase 1/2 study testing SPI-1005 in people with Meniere's Disease, run by Sound Pharmaceuticals, Incorporated at 5 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- Meniere's Disease
- What is being tested?
- SPI-1005
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 5 sitesUnited States
- Study dates
- Dec 2015to Aug 2017
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
MUSC
Charleston, South Carolina, 29425
House Clinic
Los Angeles, California, 90057
New York Otology
New York, New York, 10028
Sound Pharmaceuticals, Inc.
Seattle, Washington, 98103
Northwest Ear
Seattle, Washington, 98104
About this study
Official title: Phase 1b Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of SPI-1005 in Meniere's Disease
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.
Read the detailed description
Randomized, double-blind, placebo-controlled safety, pharmacokinetic, pharmacodynamic study of oral SPI-1005 in adults with Meniere's disease. All subjects will undergo baseline audiometric testing and have their severity of sensorineural hearing loss, tinnitus and vertigo determined before the start of a 21-day course of treatment with SPI-1005 or placebo. During treatment with SPI-1005, and 7 days and 28 days following the cessation of SPI-1005, subjects will have their hearing loss, tinnitus and vertigo assessed. Additional testing including electrocochleography will be performed at baseline, at the end of SPI-1005 treatment, and 28 days after the SPI-1005 treatment has stopped. Six outpatient visits will be performed over a 7-week period.
- Conditions
- Meniere's Disease
- Being tested
- SPI-1005
- Keywords
- Meniere's, hearing loss, vertigo, tinnitus, ebselen
- Medical subject headings
- Meniere Disease, Hearing Loss, Vertigo, Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPI-1005Drug
Also called ebselen
Ebselen is a small molecule mimic and inducer of glutathione peroxidase (GPx). GPx reduces reactive oxygen species by the binding of free radicals to its selenium moiety. Ebselen has strong anti-inflammatory characteristics.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 0 mg SPI-1005 bid po x 21d Receives: Drug: SPI-1005 |
| Low dose | Active comparator | 200 mg SPI-1005 bid po x 21d Receives: Drug: SPI-1005 |
| Mid dose | Active comparator | 400 mg SPI-1005 bid po x 21d Receives: Drug: SPI-1005 |
| High dose | Active comparator | 600 mg SPI-1005 bid po x 21d Receives: Drug: SPI-1005 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of of Treatment-Emergent Adverse Events
Safety and tolerability of SPI-1005 using histories, physical exams, and clinical measures.
Measured: 7 weeks
Secondary outcomes (6)
Plasma Ebselen Levels of SPI-1005 After 21 Days of Dosing
Trough values
Measured: 21 days
Plasma Selenium Levels
Plasma selenium levels at 28 days post-treatment
Measured: 7 weeks
Impact on Sensorineural Hearing Loss
Number of participants demonstrating improvement in Sensorineural Hearing Loss measured using pure tone audiometry. Improvement was defined as a decrease from baseline value by 10 dB or more at one or more low-frequency thresholds (0.25, 0.5, or 1.0 kHz) in at least one ear.
Measured: 7 weeks
Impact on Speech Discrimination
Number of participants demonstrating improvement in Speech Discrimination measured using the Words in Noise test. Improvement was defined as an increase from baseline value by 10% or more in the total score (0-35, where a higher score is a better outcome) in at least one ear.
Measured: 7 weeks
Impact on Tinnitus
Number of participants demonstrating improvement in the Tinnitus Functional Index (TFI). Improvement was defined as a decrease from baseline value by 10 points or more in the total score (0-100, where a higher score is a worse outcome).
Measured: 7 weeks
Impact on Vertigo
Number of participants demonstrating improvement in the Vertigo Symptom Scale - Short Form (VSS). Improvement was defined as a decrease from baseline value by 6 points or more in the total score (0-60, where a higher score is a worse outcome).
Measured: 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2015 (estimated)
- Study startDec 2015
- Primary completionAug 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Meniere's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sound Pharmaceuticals, Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jonathan Kil, MD, Study chair, Sound Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02603081
- Sponsor's protocol ID
- SPI-1005-151
- Status last verified
- Jun 2026
- First submitted
- 2 Nov 2015
- Last updated
- 29 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Kil J, Pierce C, Tran H, Gu R, Lynch ED. Ebselen treatment reduces noise induced hearing loss via the mimicry and induction of glutathione peroxidase. Hear Res. 2007 Apr;226(1-2):44-51. doi: 10.1016/j.heares.2006.08.006. Epub 2006 Oct 6.
PubMed 17030476Lynch E, Kil J. Development of ebselen, a glutathione peroxidase mimic, for the prevention and treatment of noise-induced hearing loss. Semin Hear 2009; 30(1):47-55.
Kil J, Harruff EE, Longenecker RJ. Development of ebselen for the treatment of sensorineural hearing loss and tinnitus. Hear Res. 2022 Jan;413:108209. doi: 10.1016/j.heares.2021.108209. Epub 2021 Feb 19.
PubMed 33678494Garland M, Hryckowian AJ, Tholen M, Bender KO, Van Treuren WW, Loscher S, Sonnenburg JL, Bogyo M. The Clinical Drug Ebselen Attenuates Inflammation and Promotes Microbiome Recovery in Mice after Antibiotic Treatment for CDI. Cell Rep Med. 2020 Apr 21;1(1):100005. doi: 10.1016/j.xcrm.2020.100005.
PubMed 32483557
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1b Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of SPI-1005 in Meniere's Disease
- ClinicalTrials.gov ID
- NCT02603081
- Acronym / sponsor ID
- SPI-1005-151
- Conditions
- Meniere's Disease
- Keywords
- Meniere's, hearing loss, vertigo, tinnitus, ebselen
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Sound Pharmaceuticals, IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Dec 2015
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 11 Nov 2015 (estimated)
- Results
- Posted 29 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Randomized, double-blind, placebo-controlled safety, pharmacokinetic, pharmacodynamic study of oral SPI-1005 in adults with Meniere's disease. All subjects will undergo baseline audiometric testing and have their severity of sensorineural hearing loss, tinnitus and vertigo determined before the start of a 21-day course of treatment with SPI-1005 or placebo. During treatment with SPI-1005, and 7 days and 28 days following the cessation of SPI-1005, subjects will have their hearing loss, tinnitus and vertigo assessed. Additional testing including electrocochleography will be performed at baseline, at the end of SPI-1005 treatment, and 28 days after the SPI-1005 treatment has stopped. Six outpatient visits will be performed over a 7-week period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: SPI-10050 mg SPI-1005 bid po x 21d |
| Low dose | Active comparator | Drug: SPI-1005200 mg SPI-1005 bid po x 21d |
| Mid dose | Active comparator | Drug: SPI-1005400 mg SPI-1005 bid po x 21d |
| High dose | Active comparator | Drug: SPI-1005600 mg SPI-1005 bid po x 21d |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
- 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.
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SPI-1005Also: ebselenEbselen is a small molecule mimic and inducer of glutathione peroxidase (GPx). GPx reduces reactive oxygen species by the binding of free radicals to its selenium moiety. Ebselen has strong anti-inflammatory characteristics. | Drug | High dose, Low dose, Mid dose, Placebo |
Primary outcome
Incidence of of Treatment-Emergent Adverse Events
Time frame: 7 weeks
Safety and tolerability of SPI-1005 using histories, physical exams, and clinical measures.
6 secondary outcomes
Plasma Ebselen Levels of SPI-1005 After 21 Days of Dosing
Time frame: 21 days
Plasma Selenium Levels
Time frame: 7 weeks
Impact on Sensorineural Hearing Loss
Time frame: 7 weeks
Impact on Speech Discrimination
Time frame: 7 weeks
Impact on Tinnitus
Time frame: 7 weeks
Impact on Vertigo
Time frame: 7 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17030476Kil J, Pierce C, Tran H, Gu R, Lynch ED. Ebselen treatment reduces noise induced hearing loss via the mimicry and induction of glutathione peroxidase. Hear Res. 2007 Apr;226(1-2):44-51. doi: 10.1016/j.heares.2006.08.006. Epub 2006 Oct 6.
- BackgroundLynch E, Kil J. Development of ebselen, a glutathione peroxidase mimic, for the prevention and treatment of noise-induced hearing loss. Semin Hear 2009; 30(1):47-55.
- Background: PubMed 33678494Kil J, Harruff EE, Longenecker RJ. Development of ebselen for the treatment of sensorineural hearing loss and tinnitus. Hear Res. 2022 Jan;413:108209. doi: 10.1016/j.heares.2021.108209. Epub 2021 Feb 19.
- Derived from this study: PubMed 32483557Garland M, Hryckowian AJ, Tholen M, Bender KO, Van Treuren WW, Loscher S, Sonnenburg JL, Bogyo M. The Clinical Drug Ebselen Attenuates Inflammation and Promotes Microbiome Recovery in Mice after Antibiotic Treatment for CDI. Cell Rep Med. 2020 Apr 21;1(1):100005. doi: 10.1016/j.xcrm.2020.100005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan Kil, MD study chair
Sound Pharmaceuticals
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing SPI-1005 in people with Meniere's Disease, run by Sound Pharmaceuticals, Incorporated at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of of Treatment-Emergent Adverse Events (time frame: 7 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02603081, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.