Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
254 participants
INTERVENTIONAL
2022-08-02
2024-07-25
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
SPI-1005 for the Treatment of Meniere's Disease (Open Label)
NCT06859788
Study to Evaluate SPI-1005 in Adults With Meniere's Disease
NCT02603081
Safety of APSLXR in Patients Presenting Vertigo of Vestibular Origin or Meniere's Disease
NCT04674735
Study of OTO-104 in Subjects With Unilateral Meniere's Disease
NCT02612337
Efficacy and Safety of Isosorbide Oral Solution in Patients With Meniere's Disease
NCT06765993
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
SPI-1005 400 mg BID
Oral administration of SPI-1005 400 mg BID for 28 days, with 84-day followup
Ebselen
Glutathione peroxidase mimetic
Placebo
Oral administration of matching placebo BID for 28 days, with 84-day followup
Placebo
Matching placebo containing excipients
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Ebselen
Glutathione peroxidase mimetic
Placebo
Matching placebo containing excipients
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Sound Pharmaceuticals, Incorporated
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
University of Southern California
Los Angeles, California, United States
House Clinic
Los Angeles, California, United States
Sacramento Ear, Nose, & Throat
Roseville, California, United States
George Washington University
Washington D.C., District of Columbia, United States
ENT and Allergy Associates of Florida
Boca Raton, Florida, United States
Indiana University
Indianapolis, Indiana, United States
Kansas University Medical Center
Kansas City, Kansas, United States
Advanced ENT & Allergy
Louisville, Kentucky, United States
Piedmont Ear, Nose & Throat Associates
Winston-Salem, North Carolina, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SPI-1005-351
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.