SPI-1005 for the Treatment of Meniere's Disease

Recruitment Status
COMPLETED
(See Contacts and Locations)Verified October 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 7, 2020
First Posted
December 20, 2020
Last Update Posted
July 31, 2024
Last Verified
October 2023

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

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Meniere DiseaseMénière
Drug: EbselenDrug: 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 1, 2022
Actual Primary Completion DateSeptember 18, 2023
Actual Study Completion DateJuly 24, 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
Matching placebo containing excipients

Outcome Measures

Primary Outcome Measures
  1. Incidence of Treatment-Emergent Adverse Events
    Safety and tolerability assessed based on comparison of adverse events vs. placebo
  2. Change in low frequency hearing thresholds measured by pure tone audiometry
    Co-primary efficacy endpoint; assessment of hearing by pure tone audiometry
  3. Change in Words-in-Noise Test score
    Co-primary efficacy endpoint; assessment of word recognition by Words-in-Noise Test
Secondary Outcome Measures
  1. Change in tinnitus severity
    Tinnitus Functional Index (0-100) where higher score is worse outcome
  2. Change in tinnitus loudness
    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
    Vertigo Symptom Scale (0-60) where higher score is worse outcome
  4. Change in aural fullness
    Aural Fullness Scale (0-10) where higher score is worse outcome
  5. Change in dizziness
    Dizziness Handicap Inventory (0-100) where higher score is worse outcome

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
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 CollaboratorsSound Pharmaceuticals, Incorporated
Locations
University of Arkansas for Medical Sciences | Little Rock Arkansas, United States, 72205University of Southern California | Los Angeles California, United States, 90033House Clinic | Los Angeles California, United States, 90057Sacramento Ear, Nose, & Throat | Roseville California, United States, 95661George Washington University | Washington D.C. District of Columbia, United States, 20037ENT and Allergy Associates of Florida | Boca Raton Florida, United States, 33487Indiana University | Indianapolis Indiana, United States, 46202Kansas University Medical Center | Kansas City Kansas, United States, 66160Advanced ENT & Allergy | Louisville Kentucky, United States, 40207Piedmont Ear, Nose & Throat Associates | Winston-Salem North Carolina, United States, 27103Thomas Jefferson University | Philadelphia Pennsylvania, United States, 19144Medical University of South Carolina | Charleston South Carolina, United States, 29425