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

ClinicalTrials.gov processed this data on July 30, 2024. Link to the current ClinicalTrials.gov record.

Recruitment Status

COMPLETED (See Contacts and Locations)
Verified November 2023 by Sound Pharmaceuticals, Incorporated

Sponsor

Sound Pharmaceuticals, Incorporated

Information Provided by (Responsible Party)

Sound Pharmaceuticals, Incorporated

Clinicaltrials.gov Identifier

NCT04677972
Other Study ID Numbers: SPI-1005-351
First Submitted: June 8, 2020
First Posted: December 21, 2020
Last Update Posted: August 1, 2024
Last Verified: November 2023
History of Changes

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Study Description

Not Provided
Condition or Disease Intervention/Treatment
  • Meniere Disease
  • Ménière
  • Drug: Ebselen
  • Drug: Placebo

Study Design

Study TypeInterventional
Actual Enrollment254 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingQuadruple
Primary PurposeTreatment
Official TitleA 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
Study Start DateAugust 2, 2022
Actual Primary Completion DateSeptember 19, 2023
Actual Study Completion DateJuly 25, 2024

Groups and Cohorts

Group/ CohortIntervention/ Treatment
  • 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
  • Placebo
    • Oral administration of matching placebo BID for 28 days, with 84-day followup
  • Drug: Placebo

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of Treatment-Emergent Adverse Events [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 [56 days]
      Co-primary efficacy endpoint; assessment of hearing by pure tone audiometry
    3. Change in Words-in-Noise Test score [56 days]
      Co-primary efficacy endpoint; assessment of word recognition by Words-in-Noise Test

    Secondary Outcome Measures

    1. Change in tinnitus severity [56 days]
      Tinnitus Functional Index (0-100) where higher score is worse outcome
    2. Change in tinnitus loudness [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 [56 days]
      Vertigo Symptom Scale (0-60) where higher score is worse outcome
    4. Change in aural fullness [56 days]
      Aural Fullness Scale (0-10) where higher score is worse outcome
    5. Change in dizziness [56 days]
      Dizziness Handicap Inventory (0-100) where higher score is worse outcome

    Eligibility Criteria

    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.

    Contacts and Locations

    Sponsors and Collaborators Sound Pharmaceuticals, Incorporated
    Locations
    • University of Arkansas for Medical Sciences | Little Rock, Arkansas, United States, 72205
    • University of Southern California | Los Angeles, California, United States, 90033
    • House Clinic | Los Angeles, California, United States, 90057
    • Sacramento Ear, Nose, & Throat | Roseville, California, United States, 95661
    • George Washington University | Washington, District of Columbia, United States, 20037
    • ENT and Allergy Associates of Florida | Boca Raton, Florida, United States, 33487
    • Indiana University | Indianapolis, Indiana, United States, 46202
    • Kansas University Medical Center | Kansas City, Kansas, United States, 66160
    • Advanced ENT & Allergy | Louisville, Kentucky, United States, 40207
    • Piedmont Ear, Nose & Throat Associates | Winston-Salem, North Carolina, United States, 27103
    • Thomas Jefferson University | Philadelphia, Pennsylvania, United States, 19144
    • Medical University of South Carolina | Charleston, South Carolina, United States, 29425