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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04677972
Recruitment Status : Recruiting
First Posted : December 21, 2020
Last Update Posted : March 1, 2023
Sponsor:
Information provided by (Responsible Party):
Sound Pharmaceuticals, Incorporated

Tracking Information
First Submitted Date  ICMJE June 8, 2020
First Posted Date  ICMJE December 21, 2020
Last Update Posted Date March 1, 2023
Actual Study Start Date  ICMJE August 2, 2022
Estimated Primary Completion Date July 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 18, 2020)
  • Incidence of Treatment-Emergent Adverse Events [ Time Frame: 84 days ]
    Safety and tolerability assessed based on comparison of adverse events vs. placebo
  • 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
  • Change in Words-in-Noise Test score [ Time Frame: 56 days ]
    Co-primary efficacy endpoint; assessment of word recognition by Words-in-Noise Test
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 15, 2021)
  • Change in tinnitus severity [ Time Frame: 56 days ]
    Tinnitus Functional Index (0-100) where higher score is worse outcome
  • 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
  • Change in vertigo severity [ Time Frame: 56 days ]
    Vertigo Symptom Scale (0-60) where higher score is worse outcome
  • Change in aural fullness [ Time Frame: 56 days ]
    Aural Fullness Scale (0-10) where higher score is worse outcome
  • Change in dizziness [ Time Frame: 56 days ]
    Dizziness Handicap Inventory (0-100) where higher score is worse outcome
Original Secondary Outcome Measures  ICMJE
 (submitted: December 18, 2020)
  • Change in tinnitus severity [ Time Frame: 56 days ]
    Tinnitus Functional Index (0-100) where higher score is worse outcome
  • Change in vertigo severity [ Time Frame: 56 days ]
    Vertigo Symptom Scale (0-60) where higher score is worse outcome
  • Change in aural fullness [ Time Frame: 56 days ]
    Aural Fullness Scale (0-10) where higher score is worse outcome
  • Change in dizziness [ Time Frame: 56 days ]
    Dizziness Handicap Inventory (0-100) where higher score is worse outcome
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE SPI-1005 for the Treatment of Meniere's Disease
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Meniere Disease
  • Ménière
Intervention  ICMJE
  • Drug: Ebselen
    Glutathione peroxidase mimetic
    Other Name: SPI-1005
  • Drug: Placebo
    Matching placebo containing excipients
Study Arms  ICMJE
  • Experimental: SPI-1005 400 mg BID
    Oral administration of SPI-1005 400 mg BID for 28 days, with 84-day followup
    Intervention: Drug: Ebselen
  • Placebo Comparator: Placebo
    Oral administration of matching placebo BID for 28 days, with 84-day followup
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 18, 2020)		 200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2024
Estimated Primary Completion Date July 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jonathan Kil, MD 2066342559 info@soundpharma.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04677972
Other Study ID Numbers  ICMJE SPI-1005-351
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Sound Pharmaceuticals, Incorporated
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Sound Pharmaceuticals, Incorporated
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Sound Pharmaceuticals, Incorporated
Verification Date February 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP