SPI-1005 for the Treatment of Meniere's Disease
STOPMD-3
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
1 other identifier
interventional
220
1 country
12
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Aug 2022
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 8, 2020
CompletedFirst Posted
Study publicly available on registry
December 21, 2020
CompletedStudy Start
First participant enrolled
August 2, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 19, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 25, 2024
CompletedResults Posted
Study results publicly available
June 26, 2026
CompletedJuly 23, 2026
June 1, 2026
1.1 years
June 8, 2020
June 1, 2026
June 25, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Number of Participants With Treatment-Emergent Adverse Events
Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
84 days
Change in Low Frequency Hearing Thresholds Measured by Pure Tone Audiometry
Co-primary efficacy endpoint; assessment of hearing by pure tone audiometry
84 days
Change in Words-in-Noise Test Score
Co-primary efficacy endpoint; assessment of speech discrimination by Words-in-Noise (WIN) Test (WIN Score Improvement from Baseline \>=4 words) The Words-in-Noise (WIN) test is a speech discrimination test which involves the presentation of specific words against a background noise (multi-talker babble). A total of 35 words are presented to each ear, with 5 words presented at each of 7 different signal-to-noise ratios representing increasing difficulty as the test progresses. The WIN Score is the sum total number of words correct (minimum 0, maximum 35) for each ear. A higher WIN Score is considered to be a better outcome. A WIN Score Improvement is an increase in score from baseline. The co-primary efficacy endpoint is the number of participants who had a WIN Score Improvement from Baseline of \>=4 words out of the maximum of 35 words, in one or both ears.
84 days
Secondary Outcomes (5)
Change in Tinnitus Severity
84 days
Change in Tinnitus Loudness
84 days
Change in Vertigo Severity
84 days
Change in Aural Fullness
84 days
Change in Dizziness
84 days
Study Arms (2)
SPI-1005 400 mg BID
EXPERIMENTALOral administration of SPI-1005 400 mg BID for 28 days, with 84-day followup
Placebo
PLACEBO COMPARATOROral administration of matching placebo BID for 28 days, with 84-day followup
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205, United States
University of Southern California
Los Angeles, California, 90033, United States
House Clinic
Los Angeles, California, 90057, United States
Sacramento Ear, Nose, & Throat
Roseville, California, 95661, United States
George Washington University
Washington D.C., District of Columbia, 20037, United States
ENT and Allergy Associates of Florida
Boca Raton, Florida, 33487, United States
Indiana University
Indianapolis, Indiana, 46202, United States
Kansas University Medical Center
Kansas City, Kansas, 66160, United States
Advanced ENT & Allergy
Louisville, Kentucky, 40207, United States
Piedmont Ear, Nose & Throat Associates
Winston-Salem, North Carolina, 27103, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19144, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Related Publications (3)
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.
PMID: 33678494BACKGROUNDKil 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.
PMID: 17030476BACKGROUNDKil 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.
PMID: 28716314BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Sound Pharmaceuticals, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 8, 2020
First Posted
December 21, 2020
Study Start
August 2, 2022
Primary Completion
September 19, 2023
Study Completion
July 25, 2024
Last Updated
July 23, 2026
Results First Posted
June 26, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will not share