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

Primary Purpose

Meniere Disease, Ménière

Status
Active
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Ebselen
Placebo
Sponsored by
Sound Pharmaceuticals, Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Meniere Disease focused on measuring ebselen, hearing loss, tinnitus, vertigo, dizziness, SPI-1005

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Arkansas for Medical Sciences
  • University of Southern California
  • House Clinic
  • Sacramento Ear, Nose, & Throat
  • George Washington University
  • ENT and Allergy Associates of Florida
  • Indiana University
  • Kansas University Medical Center
  • Advanced ENT & Allergy
  • Piedmont Ear, Nose & Throat Associates
  • Thomas Jefferson University
  • Medical University of South Carolina

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

SPI-1005 400 mg BID

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Incidence of Treatment-Emergent Adverse Events
Safety and tolerability assessed based on comparison of adverse events vs. placebo
Change in low frequency hearing thresholds measured by pure tone audiometry
Co-primary efficacy endpoint; assessment of hearing by pure tone audiometry
Change in Words-in-Noise Test score
Co-primary efficacy endpoint; assessment of word recognition by Words-in-Noise Test

Secondary Outcome Measures

Change in tinnitus severity
Tinnitus Functional Index (0-100) where higher score is worse outcome
Change in tinnitus loudness
Tinnitus Functional Index Question #2 -- How Strong or Loud was your Tinnitus? (0-10) where higher score is worse outcome
Change in vertigo severity
Vertigo Symptom Scale (0-60) where higher score is worse outcome
Change in aural fullness
Aural Fullness Scale (0-10) where higher score is worse outcome
Change in dizziness
Dizziness Handicap Inventory (0-100) where higher score is worse outcome

Full Information

First Posted
June 8, 2020
Last Updated
May 26, 2023
Sponsor
Sound Pharmaceuticals, Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT04677972
Brief Title
SPI-1005 for the Treatment of Meniere's Disease
Acronym
STOPMD-3
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 2, 2022 (Actual)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sound Pharmaceuticals, Incorporated

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meniere Disease, Ménière
Keywords
ebselen, hearing loss, tinnitus, vertigo, dizziness, SPI-1005

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
254 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SPI-1005 400 mg BID
Arm Type
Experimental
Arm Description
Oral administration of SPI-1005 400 mg BID for 28 days, with 84-day followup
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Oral administration of matching placebo BID for 28 days, with 84-day followup
Intervention Type
Drug
Intervention Name(s)
Ebselen
Other Intervention Name(s)
SPI-1005
Intervention Description
Glutathione peroxidase mimetic
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo containing excipients
Primary Outcome Measure Information:
Title
Incidence of Treatment-Emergent Adverse Events
Description
Safety and tolerability assessed based on comparison of adverse events vs. placebo
Time Frame
84 days
Title
Change in low frequency hearing thresholds measured by pure tone audiometry
Description
Co-primary efficacy endpoint; assessment of hearing by pure tone audiometry
Time Frame
56 days
Title
Change in Words-in-Noise Test score
Description
Co-primary efficacy endpoint; assessment of word recognition by Words-in-Noise Test
Time Frame
56 days
Secondary Outcome Measure Information:
Title
Change in tinnitus severity
Description
Tinnitus Functional Index (0-100) where higher score is worse outcome
Time Frame
56 days
Title
Change in tinnitus loudness
Description
Tinnitus Functional Index Question #2 -- How Strong or Loud was your Tinnitus? (0-10) where higher score is worse outcome
Time Frame
56 days
Title
Change in vertigo severity
Description
Vertigo Symptom Scale (0-60) where higher score is worse outcome
Time Frame
56 days
Title
Change in aural fullness
Description
Aural Fullness Scale (0-10) where higher score is worse outcome
Time Frame
56 days
Title
Change in dizziness
Description
Dizziness Handicap Inventory (0-100) where higher score is worse outcome
Time Frame
56 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
House Clinic
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Facility Name
Sacramento Ear, Nose, & Throat
City
Roseville
State/Province
California
ZIP/Postal Code
95661
Country
United States
Facility Name
George Washington University
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
ENT and Allergy Associates of Florida
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33487
Country
United States
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Kansas University Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Advanced ENT & Allergy
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Facility Name
Piedmont Ear, Nose & Throat Associates
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19144
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33678494
Citation
Kil J, Harruff EE, Longenecker RJ. Development of ebselen for the treatment of sensorineural hearing loss and tinnitus. Hear Res. 2022 Jan;413:108209. doi: 10.1016/j.heares.2021.108209. Epub 2021 Feb 19.
Results Reference
background
PubMed Identifier
17030476
Citation
Kil J, Pierce C, Tran H, Gu R, Lynch ED. Ebselen treatment reduces noise induced hearing loss via the mimicry and induction of glutathione peroxidase. Hear Res. 2007 Apr;226(1-2):44-51. doi: 10.1016/j.heares.2006.08.006. Epub 2006 Oct 6.
Results Reference
background
PubMed Identifier
28716314
Citation
Kil J, Lobarinas E, Spankovich C, Griffiths SK, Antonelli PJ, Lynch ED, Le Prell CG. Safety and efficacy of ebselen for the prevention of noise-induced hearing loss: a randomised, double-blind, placebo-controlled, phase 2 trial. Lancet. 2017 Sep 2;390(10098):969-979. doi: 10.1016/S0140-6736(17)31791-9. Epub 2017 Jul 14.
Results Reference
background

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SPI-1005 for the Treatment of Meniere's Disease

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