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Completed

NCT Number: NCT04677972

SPI-1005 for the Treatment of Meniere's Disease

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.

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Key information

Conditions

Meniere Disease Dizziness Ear Diseases Endolymphatic Hydrops Hearing Disorders Hearing Loss Labyrinth Diseases Ménière Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Tinnitus Vertigo Vestibular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ebselen

Drug

Glutathione peroxidase mimetic

Other names: SPI-1005

Placebo

Drug

Matching placebo containing excipients

Primary outcomes

  1. Number of Participants With Treatment-Emergent Adverse Events

    Time frame: 84 days

    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

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

  3. 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.

Secondary outcomes

  1. Change in Tinnitus Severity

    Time frame: 84 days

    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

    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

    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

    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

    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.

Sponsors and collaborators

Lead sponsor

Sound Pharmaceuticals, Incorporated

Industry

Registry information

Official study 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

Acronym: STOPMD-3

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Dec 21, 2020
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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