Skip to content

Trial · Interventional

CompletedPhase 3Results postedRegistry data

SPI-1005 for the Treatment of Meniere's Disease

Short name STOPMD-3

NCTNCT04677972 (opens ClinicalTrials.gov in a new tab)Other idSPI-1005-351
Open at ClinicalTrials.govAsk about this trial

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 3
Enrollment
220 participants (actual)
Sponsor
Sound Pharmaceuticals, Incorporated · Industry
Design
Randomized · Quadruple masking
Countries
1 country

United States

Start
2 Aug 2022
Primary completion
19 Sept 2023
Completion
25 Jul 2024
First posted
21 Dec 2020
Last update posted
23 Jul 2026
Conditions
Meniere Disease · Ménière

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2022202320242025
  1. Ph 3

    STOPMD-3

    NCT04677972

    2 Aug 2022 to 25 Jul 2024

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • EbselenDrug
  • PlaceboDrug

Arms2

  • Experimental

    SPI-1005 400 mg BID

    Oral administration of SPI-1005 400 mg BID for 28 days, with 84-day followup

  • Placebo comparator

    Placebo

    Oral administration of matching placebo BID for 28 days, with 84-day followup

Primary outcomes3

Outcomes the sponsor listed as primary.

  1. Number of Participants With Treatment-Emergent Adverse Events

    Time frame · 84 days

    Registry description

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

  2. Change in Low Frequency Hearing Thresholds Measured by Pure Tone Audiometry

    Time frame · 84 days

    Registry description

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

  3. Change in Words-in-Noise Test Score

    Time frame · 84 days

    Registry description

    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.

Secondary outcomes(5)

  1. Change in Tinnitus Severity

    Time frame · 84 days

    Registry description

    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.

  2. Change in Tinnitus Loudness

    Time frame · 84 days

    Registry description

    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.

  3. Change in Vertigo Severity

    Time frame · 84 days

    Registry description

    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.

  4. Change in Aural Fullness

    Time frame · 84 days

    Registry description

    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.

  5. Change in Dizziness

    Time frame · 84 days

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeCount of participants· 84 days

Number of Participants With Treatment-Emergent Adverse Events

GroupValue (Participants)
SPI-1005 400 mg BID59
Placebo45
Primary outcomeCount of participants· 84 days

Change in Low Frequency Hearing Thresholds Measured by Pure Tone Audiometry

GroupValue (Participants)
SPI-1005 400 mg BID59
Placebo40
Primary outcomeCount of participants· 84 days

Change in Words-in-Noise Test Score

GroupValue (Participants)
SPI-1005 400 mg BID45
Placebo30
Secondary and other outcome results(5)
Secondary outcomeMean· 84 days

Change in Tinnitus Severity

GroupValue (scores on a scale)Spread
SPI-1005 400 mg BID-7.920.42
Placebo-6.616.15
Secondary outcomeMean· 84 days

Change in Tinnitus Loudness

GroupValue (scores on a scale)Spread
SPI-1005 400 mg BID-0.82.22
Placebo-0.92.16
Secondary outcomeMean· 84 days

Change in Vertigo Severity

GroupValue (scores on a scale)Spread
SPI-1005 400 mg BID-0.31.16
Placebo-0.11.43
Secondary outcomeMean· 84 days

Change in Aural Fullness

GroupValue (scores on a scale)Spread
SPI-1005 400 mg BID-1.23.00
Placebo-0.62.65
Secondary outcomeMean· 84 days

Change in Dizziness

GroupValue (scores on a scale)Spread
SPI-1005 400 mg BID-5.914.71
Placebo-6.114.88

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
SPI-1005 400 mg BIDOral administration of SPI-1005 400 mg BID for 28 days, with 84-day followup Ebselen: Glutathione peroxidase mimetic0 / 1122 / 11225 / 112
PlaceboOral administration of matching placebo BID for 28 days, with 84-day followup Placebo: Matching placebo containing excipients0 / 1080 / 10819 / 108
Open Label Extension: SPI-1005 400 mg BIDOral administration of SPI-1005 400 mg BID for up to 360 days Ebselen: Glutathione peroxidase mimetic0 / 1974 / 19790 / 197

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.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 75 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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: * 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.

PepBank is a research reference. Talk to a doctor before you use any peptide.