CompletedNCT02603081Updated Jun 29, 2026Results posted

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

A Phase 1/2 interventional study of SPI-1005 in Meniere's Disease, sponsored by Sound Pharmaceuticals, Incorporated. Completed at 5 sites in United States. Open to participants aged 19 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-06-29.

Sponsored by Sound Pharmaceuticals, Incorporated · Phase 1/2, Interventional, and Treatment

Phase: Phase 1/2
Study type: Interventional
Enrollment: 40
Allocation: Randomized
Ages: 19 Years to 70 Years
Sex: All

Study 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 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 studied

Meniere's Disease

Browse trials for

Keywords

Meniere's
hearing loss
vertigo
tinnitus
ebselen

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 40 is close to 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: 19 Years to 70 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

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 should be using and committed to continue using one of the following acceptable 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

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 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 drug or device study within 90 days prior to study enrollment;
Female patients who are pregnant or breastfeeding.

Terms in these criteria, in plain language(4)

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.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Study design

Phase: Phase 1 / Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 40 participants (actual)

Study arms

Placebo comparator
Placebo
0 mg SPI-1005 bid po x 21d
Drug: SPI-1005
Active comparator
Low dose
200 mg SPI-1005 bid po x 21d
Drug: SPI-1005
Active comparator
Mid dose
400 mg SPI-1005 bid po x 21d
Drug: SPI-1005
Active comparator
High dose
600 mg SPI-1005 bid po x 21d
Drug: SPI-1005

Interventions

DrugSPI-1005
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.
Also known as: ebselen

What researchers measure

Primary outcomes

Incidence of of Treatment-Emergent Adverse Events
Safety and tolerability of SPI-1005 using histories, physical exams, and clinical measures.
Time frame: 7 weeks

Secondary outcomes

Plasma Ebselen Levels of SPI-1005 After 21 Days of Dosing
Trough values
Time frame: 21 days
Plasma Selenium Levels
Plasma selenium levels at 28 days post-treatment
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 7 weeks

Results

Posted Jun 29, 2026

Participant flow

Participant flow — Overall Study
Milestone	Placebo	Low Dose	Mid Dose	High Dose
Started	10	10	10	10
Completed	9	10	10	9
Not completed	1	0	0	1
Withdrew: Withdrawal by subject	0	0	0	1
Withdrew: Non-compliance with protocol	1	0	0	0

Outcome measures

PrimaryIncidence of of Treatment-Emergent Adverse Events

Safety and tolerability of SPI-1005 using histories, physical exams, and clinical measures.

Time frame:: 7 weeks
Reported as:: Count of participants · Participants

Incidence of of Treatment-Emergent Adverse Events
Participants	Placebo	Low Dose	Mid Dose	High Dose
Incidence of of Treatment-Emergent Adverse Events	4	2	5	5

SecondaryPlasma Ebselen Levels of SPI-1005 After 21 Days of Dosing

Trough values

Time frame:: 21 days
Reported as:: Geometric mean · ng/mL

Plasma Ebselen Levels of SPI-1005 After 21 Days of Dosing
ng/mL	Placebo	Low Dose	Mid Dose	High Dose
Ebselen	—	16.766 ± 1.4675	67.232 ± 1.4578	77.209 ± 1.5030
Ebselen Glucuronide (major metabolite)	—	102.058 ± 2.5087	505.977 ± 3.2061	506.266 ± 3.1807

SecondaryPlasma Selenium Levels

Plasma selenium levels at 28 days post-treatment

Time frame:: 7 weeks
Reported as:: Mean · ng/mL

Plasma Selenium Levels
ng/mL	Placebo	Low Dose	Mid Dose	High Dose
Plasma Selenium Levels	139.5556 ± 23.17925	171.7778 ± 32.11611	187.3333 ± 45.73292	201.7500 ± 37.96145

SecondaryImpact 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.

Time frame:: 7 weeks
Reported as:: Count of participants · Participants

Impact on Sensorineural Hearing Loss
Participants	Placebo	Low Dose	Mid Dose	High Dose
Impact on Sensorineural Hearing Loss	3	6	6	4

SecondaryImpact 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.

Time frame:: 7 weeks
Reported as:: Count of participants · Participants

Impact on Speech Discrimination
Participants	Placebo	Low Dose	Mid Dose	High Dose
Impact on Speech Discrimination	4	3	6	3

SecondaryImpact 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).

Time frame:: 7 weeks
Reported as:: Count of participants · Participants

Impact on Tinnitus
Participants	Placebo	Low Dose	Mid Dose	High Dose
Impact on Tinnitus	5	6	5	3

SecondaryImpact 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).

Time frame:: 7 weeks
Reported as:: Count of participants · Participants

Impact on Vertigo
Participants	Placebo	Low Dose	Mid Dose	High Dose
Impact on Vertigo	7	5	4	3

Adverse events

Collected over 7 weeks. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Placebo	0/10 (0%)	0/10 (0%)	4/10 (40%)
Low Dose	0/10 (0%)	0/10 (0%)	2/10 (20%)
Mid Dose	0/10 (0%)	0/10 (0%)	5/10 (50%)
High Dose	0/9 (0%)	0/9 (0%)	5/9 (55.6%)

Most frequent other events

Showing 10 of 24

Most frequent other events
Event	Placebo	Low Dose	Mid Dose	High Dose
Alanine aminotransferase increasedInvestigations	0/10	0/10	2/10	3/9
Blood cholesterol increasedInvestigations	0/10	0/10	2/10	0/9
Blood lactate dehydrogenase increasedInvestigations	0/10	0/10	2/10	0/9
HyperglycaemiaMetabolism and nutrition disorders	0/10	0/10	2/10	0/9
Dry eyeEye disorders	0/10	0/10	0/10	1/9
FlatulenceGastrointestinal disorders	0/10	0/10	0/10	1/9
Kidney infectionInfections and infestations	0/10	1/10	0/10	1/9
Ophthalmic herpes simplexInfections and infestations	0/10	1/10	0/10	1/9
PharyngitisInfections and infestations	0/10	0/10	1/10	1/9
Aspartate aminotransferase increasedInvestigations	0/10	0/10	1/10	1/9

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Placebo	Low Dose	Mid Dose	High Dose	Total
Mean	54.5 ± 9.88	50.9 ± 9.75	48.7 ± 9.30	56.3 ± 9.27	52.6 ± 9.66

Sex: Female, Male
Sex: Female, Male(Participants)	Placebo	Low Dose	Mid Dose	High Dose	Total
Female	5	6	5	4	20
Male	5	4	5	6	20

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Placebo	Low Dose	Mid Dose	High Dose	Total
Hispanic or Latino	1	0	0	0	1
Not Hispanic or Latino	9	10	10	10	39
Unknown or Not Reported	0	0	0	0	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Placebo	Low Dose	Mid Dose	High Dose	Total
American Indian or Alaska Native	0	0	0	0	0
Asian	0	1	0	0	1
Native Hawaiian or Other Pacific Islander	0	0	0	0	0
Black or African American	0	1	0	1	2
White	10	7	10	9	36
More than one race	0	0	0	0	0
Unknown or Not Reported	0	1	0	0	1

Region of Enrollment
Region of Enrollment(participants)	Placebo	Low Dose	Mid Dose	High Dose	Total
United States	10	10	10	10	40

Plasma Selenium level
Plasma Selenium level(ng/mL)	Placebo	Low Dose	Mid Dose	High Dose	Total
Mean	162.0000 ± 55.30145	138.5714 ± 16.91013	153.6000 ± 18.06900	157.5556 ± 25.94760	153.7714 ± 32.9269

Study locations

5 sites

House Clinic
Los Angeles, California 90057, United States
New York Otology
New York, New York 10028, United States
MUSC
Charleston, South Carolina 29425, United States
Sound Pharmaceuticals, Inc.
Seattle, Washington 98103, United States
Northwest Ear
Seattle, Washington 98104, United States

References and documents

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 17030476 ↗
Lynch 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 33678494 ↗
Garland 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 documents

Study protocol ↗ · Nov 14, 2016
Statistical analysis plan ↗ · Sep 7, 2017

PDFs hosted by the registry, ClinicalTrials.gov.

Timeline

Tracking since Sep 25, 2026

Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Dec 2015, a primary completion of Aug 2017 and a completion of Aug 2017. It does not say whether these dates are actual or estimated.

Results were first posted in Jun 2026, 8 years 10 months after primary completion.

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

Registered: Nov 2, 2015
First posted: Nov 11, 2015
Start: Dec 2015
Primary completionActual: Aug 2017
CompletionActual: Aug 2017
Results first posted: Jun 29, 2026
Last update: Jun 29, 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 Jun 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02603081
Lead sponsor: Sound Pharmaceuticals, Incorporated
Responsible party: Sponsor
First posted: Nov 11, 2015
Start date: Dec 2015
Primary completion: Aug 2017
Completion: Aug 2017
Results posted: Jun 29, 2026
Last update: Jun 29, 2026

Study contacts

Jonathan Kil, MD

study chair · Sound Pharmaceuticals

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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