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SPI-1005 for the Treatment of Meniere's Disease (STOPMD-3)

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ClinicalTrials.gov Identifier: NCT04677972
Recruitment Status : Recruiting
First Posted : December 21, 2020
Last Update Posted : March 1, 2023
Information provided by (Responsible Party):
Sound Pharmaceuticals, Incorporated

Brief 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.

Condition or disease Intervention/treatment Phase
Meniere Disease Ménière Drug: Ebselen Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : August 2, 2022
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : August 2024

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: SPI-1005 400 mg BID
Oral administration of SPI-1005 400 mg BID for 28 days, with 84-day followup
Drug: Ebselen
Glutathione peroxidase mimetic
Other Name: SPI-1005

Placebo Comparator: Placebo
Oral administration of matching placebo BID for 28 days, with 84-day followup
Drug: Placebo
Matching placebo containing excipients

Primary Outcome Measures :
  1. Incidence of Treatment-Emergent Adverse Events [ Time Frame: 84 days ]
    Safety and tolerability assessed based on comparison of adverse events vs. placebo

  2. Change in low frequency hearing thresholds measured by pure tone audiometry [ Time Frame: 56 days ]
    Co-primary efficacy endpoint; assessment of hearing by pure tone audiometry

  3. Change in Words-in-Noise Test score [ Time Frame: 56 days ]
    Co-primary efficacy endpoint; assessment of word recognition by Words-in-Noise Test

Secondary Outcome Measures :
  1. Change in tinnitus severity [ Time Frame: 56 days ]
    Tinnitus Functional Index (0-100) where higher score is worse outcome

  2. Change in tinnitus loudness [ Time Frame: 56 days ]
    Tinnitus Functional Index Question #2 -- How Strong or Loud was your Tinnitus? (0-10) where higher score is worse outcome

  3. Change in vertigo severity [ Time Frame: 56 days ]
    Vertigo Symptom Scale (0-60) where higher score is worse outcome

  4. Change in aural fullness [ Time Frame: 56 days ]
    Aural Fullness Scale (0-10) where higher score is worse outcome

  5. Change in dizziness [ Time Frame: 56 days ]
    Dizziness Handicap Inventory (0-100) where higher score is worse outcome

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04677972

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Contact: Jonathan Kil, MD 2066342559 info@soundpharma.com

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United States, Arkansas
University of Arkansas for Medical Sciences Recruiting
Little Rock, Arkansas, United States, 72205
Contact: Monica Smith       mrsmith@uams.edu   
United States, California
University of Southern California Recruiting
Los Angeles, California, United States, 90033
Contact: Gita Itani    323-865-6156    gita.itani@med.usc.edu   
House Clinic Recruiting
Los Angeles, California, United States, 90057
Contact: Clinical Trials    213-770-1808    clinicaltrials@hifla.org   
Sacramento Ear, Nose, & Throat Recruiting
Roseville, California, United States, 95661
Contact: Rose Khalatyan, MPH    916-531-2788    rkhalatyan@davinciresearch.net   
United States, District of Columbia
George Washington University Recruiting
Washington, District of Columbia, United States, 20037
Contact: Tremaine Brock       tbrock@mfa.gwu.edu   
United States, Florida
ENT and Allergy Associates of Florida Recruiting
Boca Raton, Florida, United States, 33487
Contact: O. Sandy DiBattista, CCMA    561-834-4670    oadibattista@entaaf.com   
United States, Indiana
Indiana University Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Joey Calcagno    317-274-3121    Jcalcagn@IU.edu   
United States, Kansas
Kansas University Medical Center Recruiting
Kansas City, Kansas, United States, 66160
Contact: Bryan Humphrey       bhumphrey@kumc.edu   
United States, Kentucky
Advanced ENT & Allergy Recruiting
Louisville, Kentucky, United States, 40207
Contact: Pamela McCullough, PhD    502-893-0159 ext 1180    PMcCullough@advancedentandallergy.com   
United States, North Carolina
Piedmont Ear, Nose & Throat Associates Recruiting
Winston-Salem, North Carolina, United States, 27103
Contact: Onyi Ukaegbe, PhD    336-714-1039 ext 222      
United States, Pennsylvania
Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19144
Contact: Jay Shah       Jay.Shah2@jefferson.edu   
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Director of Clinical Research    843-792-1356      
Sponsors and Collaborators
Sound Pharmaceuticals, Incorporated
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Responsible Party: Sound Pharmaceuticals, Incorporated
ClinicalTrials.gov Identifier: NCT04677972    
Other Study ID Numbers: SPI-1005-351
First Posted: December 21, 2020    Key Record Dates
Last Update Posted: March 1, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sound Pharmaceuticals, Incorporated:
hearing loss
Additional relevant MeSH terms:
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Meniere Disease
Endolymphatic Hydrops
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Anti-Ulcer Agents
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Neuroprotective Agents