Primary outcomeCount of participants· 7 weeks
Incidence of of Treatment-Emergent Adverse Events
| Group | Value (Participants) |
|---|---|
| Placebo | 4 |
| Low Dose | 2 |
| Mid Dose | 5 |
| High Dose | 5 |
Trial · Interventional
CompletedPhase 1/2Results postedRegistry dataStudy to Evaluate SPI-1005 in Adults With Meniere's Disease
NCTNCT02603081 (opens ClinicalTrials.gov in a new tab)Other idSPI-1005-151
This trial does not test a peptide that PepBank tracks.
- Names Glutathione, does not test it. It appears in the description.
Overview
- Status
- Completed
- Phase
- Phase 1/2
- Enrollment
- 40 participants (actual)
- Sponsor
- Sound Pharmaceuticals, Incorporated · Industry
- Design
- Randomized · Double masking
- Countries
1 country
United States
- Start
- Dec 2015
- Primary completion
- Aug 2017
- Completion
- Aug 2017
- First posted
- 11 Nov 2015 (estimated)
- Last update posted
- 29 Jun 2026
- Conditions
- Meniere's Disease
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
2015201620172018
- Ph 1/2
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- SPI-1005Drug
Arms4
Placebo comparator
Placebo
0 mg SPI-1005 bid po x 21d
Active comparator
Low dose
200 mg SPI-1005 bid po x 21d
Active comparator
Mid dose
400 mg SPI-1005 bid po x 21d
Active comparator
High dose
600 mg SPI-1005 bid po x 21d
Primary outcomes1
Outcomes the sponsor listed as primary.
Incidence of of Treatment-Emergent Adverse Events
Time frame · 7 weeks
Registry description
Safety and tolerability of SPI-1005 using histories, physical exams, and clinical measures.
Secondary outcomes(6)
Plasma Ebselen Levels of SPI-1005 After 21 Days of Dosing
Time frame · 21 days
Registry description
Trough values
Plasma Selenium Levels
Time frame · 7 weeks
Registry description
Plasma selenium levels at 28 days post-treatment
Impact on Sensorineural Hearing Loss
Time frame · 7 weeks
Registry description
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.
Impact on Speech Discrimination
Time frame · 7 weeks
Registry description
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.
Impact on Tinnitus
Time frame · 7 weeks
Registry description
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).
Impact on Vertigo
Time frame · 7 weeks
Registry description
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).
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(6)
Secondary outcomeGeometric mean· 21 days
Plasma Ebselen Levels of SPI-1005 After 21 Days of Dosing
| Group | Value (ng/mL) | Spread |
|---|---|---|
| Placebo | not posted | – |
| Low Dose | 16.766 | 1.4675 |
| Mid Dose | 67.232 | 1.4578 |
| High Dose | 77.209 | 1.5030 |
Secondary outcomeMean· 7 weeks
Plasma Selenium Levels
| Group | Value (ng/mL) | Spread |
|---|---|---|
| Placebo | 139.5556 | 23.17925 |
| Low Dose | 171.7778 | 32.11611 |
| Mid Dose | 187.3333 | 45.73292 |
| High Dose | 201.7500 | 37.96145 |
Secondary outcomeCount of participants· 7 weeks
Impact on Sensorineural Hearing Loss
| Group | Value (Participants) |
|---|---|
| Placebo | 3 |
| Low Dose | 6 |
| Mid Dose | 6 |
| High Dose | 4 |
Secondary outcomeCount of participants· 7 weeks
Impact on Speech Discrimination
| Group | Value (Participants) |
|---|---|
| Placebo | 4 |
| Low Dose | 3 |
| Mid Dose | 6 |
| High Dose | 3 |
Secondary outcomeCount of participants· 7 weeks
Impact on Tinnitus
| Group | Value (Participants) |
|---|---|
| Placebo | 5 |
| Low Dose | 6 |
| Mid Dose | 5 |
| High Dose | 3 |
Secondary outcomeCount of participants· 7 weeks
Impact on Vertigo
| Group | Value (Participants) |
|---|---|
| Placebo | 7 |
| Low Dose | 5 |
| Mid Dose | 4 |
| High Dose | 3 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Placebo0 mg SPI-1005 bid po x 21d SPI-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. | 0 / 10 | 0 / 10 | 4 / 10 |
| Low Dose200 mg SPI-1005 bid po x 21d SPI-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. | 0 / 10 | 0 / 10 | 2 / 10 |
| Mid Dose400 mg SPI-1005 bid po x 21d SPI-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. | 0 / 10 | 0 / 10 | 5 / 10 |
| High Dose600 mg SPI-1005 bid po x 21d SPI-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. | 0 / 9 | 0 / 9 | 5 / 9 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Other registry references
References listed at the registry that are not in PepBank. They link to PubMed.
- DerivedGarland 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. PMID 32483557
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 19 Years up to 70 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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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