Meniere DiseasePhase 3STOPMD-3NCT04677972
SPI-1005 for the Treatment of Meniere's Disease
A Phase 3 study testing Ebselen in people with Meniere Disease and Ménière, run by Sound Pharmaceuticals, Incorporated at 12 sites in United States.
Trial summary
The study is a randomized, double-blind, placebo-controlled, multi-center clinical trial (RCT) with open-label extension study (OLE), of SPI-1005 in adult subjects with definite Meniere's disease with active symptoms within three months preceding study enrollment. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Meniere Disease, Ménière
- What is being tested?
- Ebselen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 220 participants
- Where
- 12 sitesUnited States
- Study dates
- 2 Aug 2022to 25 Jul 2024
- Phase
- Phase 3
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult males/females, 18-75 years of age at the time of enrollment.
- Diagnosis of definite Meniere's Disease by AAO-HNS Amended 2015 Criteria.
- Hearing loss of ≥30 dB at 250, 500, or 1000 Hz at study enrollment.
- At least two of three active symptoms (tinnitus; aural fullness; vertigo or dizziness) of Meniere's disease by AAO-HNS Amended 2015 Criteria, within 3 months of study enrollment.
Who cannot join
- Current, or within 60 days prior to study enrollment, use of IV ototoxic medications
- History of otosclerosis or vestibular schwannoma.
- History of significant middle ear or inner ear surgery in the affected ear.
- Conductive hearing loss with air-bone gap ≥15 dB, otitis media, or mixed hearing loss.
- Significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, neurological, or psychiatric disease.
- Current use or within 30 days prior to study enrollment systemic steroids.
- Current use or within 7 days prior to study enrollment intratympanic steroids.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
ENT and Allergy Associates of Florida
Boca Raton, Florida, 33487
Medical University of South Carolina
Charleston, South Carolina, 29425
Indiana University
Indianapolis, Indiana, 46202
Kansas University Medical Center
Kansas City, Kansas, 66160
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
University of Southern California
Los Angeles, California, 90033
House Clinic
Los Angeles, California, 90057
Advanced ENT & Allergy
Louisville, Kentucky, 40207
Thomas Jefferson University
Philadelphia, Pennsylvania, 19144
Sacramento Ear, Nose, & Throat
Roseville, California, 95661
George Washington University
Washington D.C., District of Columbia, 20037
Piedmont Ear, Nose & Throat Associates
Winston-Salem, North Carolina, 27103
About this study
Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of SPI-1005 in Meniere's Disease and Open Label Extension Study to Evaluate the Chronic Safety of SPI-1005
The study is a randomized, double-blind, placebo-controlled, multi-center clinical trial (RCT) with open-label extension study (OLE), of SPI-1005 in adult subjects with definite Meniere's disease with active symptoms within three months preceding study enrollment.
- Conditions
- Meniere Disease, Ménière
- Being tested
- Ebselen, Placebo
- Keywords
- ebselen, hearing loss, tinnitus, vertigo, dizziness, SPI-1005
- Medical subject headings
- Meniere Disease, Hearing Loss, Tinnitus, Vertigo, Dizziness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EbselenDrug
Also called SPI-1005
Glutathione peroxidase mimetic
PlaceboDrug
Matching placebo containing excipients
| Study group | Role | What they receive |
|---|---|---|
| SPI-1005 400 mg BID | Experimental | Oral administration of SPI-1005 400 mg BID for 28 days, with 84-day followup Receives: Drug: Ebselen |
| Placebo | Placebo comparator | Oral administration of matching placebo BID for 28 days, with 84-day followup Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-Emergent Adverse Events
Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
Measured: 84 days
Change in Low Frequency Hearing Thresholds Measured by Pure Tone Audiometry
Co-primary efficacy endpoint; assessment of hearing by pure tone audiometry
Measured: 84 days
Change in Words-in-Noise Test Score
Co-primary efficacy endpoint; assessment of speech discrimination by Words-in-Noise (WIN) Test (WIN Score Improvement from Baseline >=4 words)
The Words-in-Noise (WIN) test is a speech discrimination test which involves the presentation of specific words against a background noise (multi-talker babble). A total of 35 words are presented to each ear, with 5 words presented at each of 7 different signal-to-noise ratios representing increasing difficulty as the test progresses. The WIN Score is the sum total number of words correct (minimum 0, maximum 35) for each ear. A higher WIN Score is considered to be a better outcome. A WIN Score Improvement is an increase in score from baseline.
The co-primary efficacy endpoint is the number of participants who had a WIN Score Improvement from Baseline of >=4 words out of the maximum of 35 words, in one or both ears.
Measured: 84 days
Secondary outcomes (5)
Change in Tinnitus Severity
Tinnitus Functional Index (0-100) where higher score is worse outcome. Mean change from baseline is reported, where a decrease in score is a better outcome.
Measured: 84 days
Change in Tinnitus Loudness
Tinnitus Functional Index Question #2 -- How Strong or Loud was your Tinnitus? (0-10) where higher score is worse outcome. Mean change from baseline is reported, where a decrease in score is a better outcome.
Measured: 84 days
Change in Vertigo Severity
Vertigo Symptom Scale (0-60) where higher score is worse outcome. Mean change from baseline is reported, where a decrease in score is a better outcome.
Measured: 84 days
Change in Aural Fullness
Aural Fullness Scale (0-10) where higher score is worse outcome. Mean change from baseline is reported, where a decrease in score is a better outcome.
Measured: 84 days
Change in Dizziness
Dizziness Handicap Inventory (0-100) where higher score is worse outcome. Mean change from baseline is reported, where a decrease in score is a better outcome.
Measured: 84 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2020
- Study start2 Aug 2022
- Primary completion19 Sep 2023
- Study completion25 Jul 2024
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 (3)Papers the sponsor has linked to this study.
- Other trials for Meniere 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sound Pharmaceuticals, Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04677972
- Sponsor's protocol ID
- SPI-1005-351
- Acronym
- STOPMD-3
- Status last verified
- Jun 2026
- First submitted
- 8 Jun 2020
- Last updated
- 23 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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 33678494Kil 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 17030476Kil J, Lobarinas E, Spankovich C, Griffiths SK, Antonelli PJ, Lynch ED, Le Prell CG. Safety and efficacy of ebselen for the prevention of noise-induced hearing loss: a randomised, double-blind, placebo-controlled, phase 2 trial. Lancet. 2017 Sep 2;390(10098):969-979. doi: 10.1016/S0140-6736(17)31791-9. Epub 2017 Jul 14.
PubMed 28716314
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of SPI-1005 in Meniere's Disease and Open Label Extension Study to Evaluate the Chronic Safety of SPI-1005
- ClinicalTrials.gov ID
- NCT04677972
- Acronym / sponsor ID
- STOPMD-3 / SPI-1005-351
- Conditions
- Meniere Disease, Ménière
- Keywords
- ebselen, hearing loss, tinnitus, vertigo, dizziness, SPI-1005
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Sound Pharmaceuticals, IncorporatedIndustry (pharma, biotech, devices)
- Study start
- 2 Aug 2022 (actual)
- Primary completion
- 19 Sep 2023 (actual)
- Study completion
- 25 Jul 2024 (actual)
- First posted
- 21 Dec 2020 (actual)
- Results
- Posted 26 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is a randomized, double-blind, placebo-controlled, multi-center clinical trial (RCT) with open-label extension study (OLE), of SPI-1005 in adult subjects with definite Meniere's disease with active symptoms within three months preceding study enrollment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SPI-1005 400 mg BID | Experimental | Drug: EbselenOral administration of SPI-1005 400 mg BID for 28 days, with 84-day followup |
| Placebo | Placebo comparator | Drug: PlaceboOral administration of matching placebo BID for 28 days, with 84-day followup |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult males/females, 18-75 years of age at the time of enrollment.
- Diagnosis of definite Meniere's Disease by AAO-HNS Amended 2015 Criteria.
- Hearing loss of ≥30 dB at 250, 500, or 1000 Hz at study enrollment.
- At least two of three active symptoms (tinnitus; aural fullness; vertigo or dizziness) of Meniere's disease by AAO-HNS Amended 2015 Criteria, within 3 months of study enrollment.
Key exclusion criteria (7 listed)
- Current, or within 60 days prior to study enrollment, use of IV ototoxic medications
- History of otosclerosis or vestibular schwannoma.
- History of significant middle ear or inner ear surgery in the affected ear.
- Conductive hearing loss with air-bone gap ≥15 dB, otitis media, or mixed hearing loss.
- Significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, neurological, 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 |
|---|---|---|
| EbselenAlso: SPI-1005Glutathione peroxidase mimetic | Drug | SPI-1005 400 mg BID |
| PlaceboMatching placebo containing excipients | Drug | Placebo |
Primary outcome
Number of Participants With Treatment-Emergent Adverse Events
Time frame: 84 days
Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
Change in Low Frequency Hearing Thresholds Measured by Pure Tone Audiometry
Time frame: 84 days
Co-primary efficacy endpoint; assessment of hearing by pure tone audiometry
Change in Words-in-Noise Test Score
Time frame: 84 days
Co-primary efficacy endpoint; assessment of speech discrimination by Words-in-Noise (WIN) Test (WIN Score Improvement from Baseline >=4 words) The Words-in-Noise (WIN) test is a speech discrimination test which involves the presentation of specific words against a background noise (multi-talker babble). A total of 35 words are presented to each ear, with 5 words presented at each of 7 different signal-to-noise ratios representing increasing difficulty as the test progresses. The WIN Score is the sum total number of words correct (minimum 0, maximum 35) for each ear. A higher WIN Score is considered to be a better outcome. A WIN Score Improvement is an increase in score from baseline. The co-primary efficacy endpoint is the number of participants who had a WIN Score Improvement from Baseline of >=4 words out of the maximum of 35 words, in one or both ears.
5 secondary outcomes
Change in Tinnitus Severity
Time frame: 84 days
Change in Tinnitus Loudness
Time frame: 84 days
Change in Vertigo Severity
Time frame: 84 days
Change in Aural Fullness
Time frame: 84 days
Change in Dizziness
Time frame: 84 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
- 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.
- Background: PubMed 28716314Kil J, Lobarinas E, Spankovich C, Griffiths SK, Antonelli PJ, Lynch ED, Le Prell CG. Safety and efficacy of ebselen for the prevention of noise-induced hearing loss: a randomised, double-blind, placebo-controlled, phase 2 trial. Lancet. 2017 Sep 2;390(10098):969-979. doi: 10.1016/S0140-6736(17)31791-9. Epub 2017 Jul 14.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ebselen in people with Meniere Disease and Ménière, run by Sound Pharmaceuticals, Incorporated at 12 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 4 inclusion and 7 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 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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 phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 26 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?
Number of Participants With Treatment-Emergent Adverse Events (time frame: 84 days). The study lists 3 primary outcomes in all. 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 NCT04677972, which also lists 3 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 23 Jul 2026.