CompletedNCT04677972STOPMD-3Updated Jul 23, 2026Results posted

SPI-1005 for the Treatment of Meniere's Disease

A Phase 3 interventional study of Ebselen and Placebo in Meniere Disease and Ménière, sponsored by Sound Pharmaceuticals, Incorporated. Completed at 12 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-07-23.

Sponsored by Sound Pharmaceuticals, Incorporated · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 220
Allocation: Randomized
Ages: 18 Years to 75 Years
Sex: All

Study 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.

Conditions studied

Meniere Disease
Ménière

Browse trials for

Keywords

ebselen
hearing loss
tinnitus
vertigo
dizziness
SPI-1005

In context

Meniere Disease

74 studies on the registry are indexed under Meniere Disease; 12 are open to participants now.

This study's enrollment of 220 is above the median of 44 across 61 interventional studies indexed under Meniere Disease.

Browse Meniere Disease studies →

Lead sponsor

Sound Pharmaceuticals, Incorporated is the lead sponsor of 13 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 75 Years
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria:

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 .
Current use or within 7 days prior to study enrollment intratympanic steroids.

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 220 participants (actual)

Study arms

Experimental
SPI-1005 400 mg BID
Oral administration of SPI-1005 400 mg BID for 28 days, with 84-day followup
Drug: Ebselen
Placebo comparator
Placebo
Oral administration of matching placebo BID for 28 days, with 84-day followup
Drug: Placebo

Interventions

DrugEbselen
Glutathione peroxidase mimetic
Also known as: SPI-1005
DrugPlacebo
Matching placebo containing excipients

What researchers measure

Primary outcomes

Number of Participants With Treatment-Emergent Adverse Events
Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
Time frame: 84 days
Change in Low Frequency Hearing Thresholds Measured by Pure Tone Audiometry
Co-primary efficacy endpoint; assessment of hearing by pure tone audiometry
Time frame: 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.
Time frame: 84 days

Secondary outcomes

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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 84 days

Results

Posted Jun 26, 2026

Participant flow

Randomized Controlled Trial (RCT)

Participant flow — Randomized Controlled Trial (RCT)
Milestone	SPI-1005 400 mg BID	Placebo
Started	112	108
Completed	106	105
Not completed	6	3
Withdrew: Adverse event	1	0
Withdrew: Withdrawal by subject	1	0
Withdrew: Protocol violation	4	3

Open Label Extension (OLE)

Participant flow — Open Label Extension (OLE)
Milestone	SPI-1005 400 mg BID	Placebo
Started	197	0
Day 180 (6-months treatment)	153	0
Day 360 (12-months treatment)	89	0
Completed	125	0
Not completed	72	0
Withdrew: Withdrawal by subject	36	0
Withdrew: Protocol violation	26	0
Withdrew: Lost to follow-up	6	0
Withdrew: Physician decision	2	0
Withdrew: Adverse event	2	0

Outcome measures

PrimaryNumber of Participants With Treatment-Emergent Adverse Events

Number of Participants with Treatment-Emergent Adverse Events (TEAEs)

Time frame:: 84 days
Reported as:: Count of participants · Participants

Number of Participants With Treatment-Emergent Adverse Events
Participants	SPI-1005 400 mg BID	Placebo
Total Number of Patients with Treatment Emergent Adverse Events (TEAE)	59	45
Number of Patients with Mild TEAE	32	17
Number of Patients with Moderate TEAE	23	26
Number of Patients with Severe TEAE	4	2

PrimaryChange in Low Frequency Hearing Thresholds Measured by Pure Tone Audiometry

Co-primary efficacy endpoint; assessment of hearing by pure tone audiometry

Time frame:: 84 days
Reported as:: Count of participants · Participants

Change in Low Frequency Hearing Thresholds Measured by Pure Tone Audiometry
Participants	SPI-1005 400 mg BID	Placebo
Threshold Improvement from Baseline >=10 dB in at least 1 low frequency (250, 500, or 1000Hz)	59	40
Threshold Improvement from Baseline >=10 dB in 2 adjacent low frequencies (250, 500, or 1000Hz)	43	16

PrimaryChange 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.

Time frame:: 84 days
Reported as:: Count of participants · Participants

Change in Words-in-Noise Test Score
Participants	SPI-1005 400 mg BID	Placebo
Change in Words-in-Noise Test Score	45	30

SecondaryChange 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.

Time frame:: 84 days
Reported as:: Mean · scores on a scale

Change in Tinnitus Severity
scores on a scale	SPI-1005 400 mg BID	Placebo
Change in Tinnitus Severity	-7.9 ± 20.42	-6.6 ± 16.15

SecondaryChange 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.

Time frame:: 84 days
Reported as:: Mean · scores on a scale

Change in Tinnitus Loudness
scores on a scale	SPI-1005 400 mg BID	Placebo
Change in Tinnitus Loudness	-0.8 ± 2.22	-0.9 ± 2.16

SecondaryChange 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.

Time frame:: 84 days
Reported as:: Mean · scores on a scale

Change in Vertigo Severity
scores on a scale	SPI-1005 400 mg BID	Placebo
Change in Vertigo Severity	-0.3 ± 1.16	-0.1 ± 1.43

SecondaryChange 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.

Time frame:: 84 days
Reported as:: Mean · scores on a scale

Change in Aural Fullness
scores on a scale	SPI-1005 400 mg BID	Placebo
Change in Aural Fullness	-1.2 ± 3.00	-0.6 ± 2.65

SecondaryChange 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.

Time frame:: 84 days
Reported as:: Mean · scores on a scale

Change in Dizziness
scores on a scale	SPI-1005 400 mg BID	Placebo
Change in Dizziness	-5.9 ± 14.71	-6.1 ± 14.88

Adverse events

Collected over SPI-1005 400 mg BID & Placebo: 3 months Open Label Extension: SPI-1005 400 mg BID: 6 to 12 months. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
SPI-1005 400 mg BID	0/112 (0%)	2/112 (1.8%)	25/112 (22.3%)
Placebo	0/108 (0%)	0/108 (0%)	19/108 (17.6%)
Open Label Extension: SPI-1005 400 mg BID	0/197 (0%)	4/197 (2%)	90/197 (45.7%)

Most frequent serious events

Most frequent serious events
Event	SPI-1005 400 mg BID	Placebo	Open Label Extension: SPI-1005 400 mg BID
HypoacusisEar and labyrinth disorders	1/112	0/108	0/197
DiverticulitisInfections and infestations	1/112	0/108	0/197
NauseaGastrointestinal disorders	0/112	0/108	1/197
VomitingGastrointestinal disorders	0/112	0/108	1/197
Ankle fractureInjury, poisoning and procedural complications	0/112	0/108	1/197
DepressionPsychiatric disorders	0/112	0/108	1/197
Knee arthroplastySurgical and medical procedures	0/112	0/108	1/197

Most frequent other events

Most frequent other events
Event	SPI-1005 400 mg BID	Placebo	Open Label Extension: SPI-1005 400 mg BID
Alanine aminotransferase increasedInvestigations	1/112	11/108	32/197
VertigoEar and labyrinth disorders	11/112	9/108	25/197
TinnitusEar and labyrinth disorders	10/112	7/108	23/197
Aspartate aminotransferase increasedInvestigations	1/112	6/108	21/197
COVID-19Infections and infestations	3/112	3/108	18/197
HypoacusisEar and labyrinth disorders	4/112	6/108	14/197
DizzinessNervous system disorders	4/112	0/108	13/197
Ear discomfortEar and labyrinth disorders	4/112	2/108	10/197

Baseline characteristics

Age, Continuous
Age, Continuous(years)	SPI-1005 400 mg BID	Placebo	Total
Mean	54.5 ± 11.55	56.8 ± 10.58	55.7 ± 11.12

Sex: Female, Male
Sex: Female, Male(Participants)	SPI-1005 400 mg BID	Placebo	Total
Female	46	55	101
Male	66	53	119

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	SPI-1005 400 mg BID	Placebo	Total
Hispanic or Latino	4	5	9
Not Hispanic or Latino	108	103	211
Unknown or Not Reported	0	0	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	SPI-1005 400 mg BID	Placebo	Total
American Indian or Alaska Native	0	0	0
Asian	6	1	7
Native Hawaiian or Other Pacific Islander	0	1	1
Black or African American	6	2	8
White	97	102	199
More than one race	0	0	0
Unknown or Not Reported	3	2	5

Region of Enrollment
Region of Enrollment(participants)	SPI-1005 400 mg BID	Placebo	Total
United States	112	108	220

Study locations

12 sites

University of Arkansas for Medical Sciences
Little Rock, Arkansas 72205, United States
University of Southern California
Los Angeles, California 90033, United States
House Clinic
Los Angeles, California 90057, United States
Sacramento Ear, Nose, & Throat
Roseville, California 95661, United States
George Washington University
Washington D.C., District of Columbia 20037, United States
ENT and Allergy Associates of Florida
Boca Raton, Florida 33487, United States
Indiana University
Indianapolis, Indiana 46202, United States
Kansas University Medical Center
Kansas City, Kansas 66160, United States
Advanced ENT & Allergy
Louisville, Kentucky 40207, United States
Piedmont Ear, Nose & Throat Associates
Winston-Salem, North Carolina 27103, United States
Thomas Jefferson University
Philadelphia, Pennsylvania 19144, United States
Medical University of South Carolina
Charleston, South Carolina 29425, United States

References and documents

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 33678494 ↗
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 17030476 ↗
Kil 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 documents

Study protocol ↗ · Apr 8, 2021
Statistical analysis plan ↗ · Sep 20, 2024

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reached

Ran from Aug 2022 to primary completion in Sep 2023, 13 months.

Results were first posted in Jun 2026, 2 years 9 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered: Jun 8, 2020
First posted: Dec 21, 2020
StartActual: Aug 2, 2022
Primary completionActual: Sep 19, 2023
CompletionActual: Jul 25, 2024
Results first posted: Jun 26, 2026
Last update: Jul 23, 2026

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Jul 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04677972
Lead sponsor: Sound Pharmaceuticals, Incorporated
Responsible party: Sponsor
First posted: Dec 21, 2020
Start date: Aug 2, 2022
Primary completion: Sep 19, 2023
Completion: Jul 25, 2024
Results posted: Jun 26, 2026
Last update: Jul 23, 2026

Oversight

Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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