Ebselen for Vertigo, Aural
Phase-Based Progress Estimates
Effectiveness
Safety
Michigan Ear Institute, Farmington Hills, MI
Vertigo, Aural+1 More
Ebselen - DrugEligibility
18+
All Sexes
What conditions do you have?
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Eligibility
18+
All Sexes
What conditions do you have?
Select
Study Summary
This trial is testing a new drug for Meniere's disease, a disorder of the inner ear. The trial is comparing the drug to a placebo, and is double-blind (neither the subjects nor the researchers know who is receiving the drug or the placebo). Ebselen is used to treat the condition known as vertigo, which is a type of dizziness that is caused by specific changes in head position.
Eligible Conditions
- Vertigo, Aural
- Ménière
Treatment Effectiveness
Effectiveness Progress
This is further along than 85% of similar trials
Study Objectives
3 Primary · 5 Secondary · Reporting Duration: 84 days
56 days
Change in Words-in-Noise Test score
Change in aural fullness
Change in dizziness
Change in low frequency hearing thresholds measured by pure tone audiometry
Change in tinnitus loudness
Change in tinnitus severity
Change in vertigo severity
84 days
Incidence of Treatment-Emergent Adverse Events
Trial Safety
Safety Progress
This is further along than 85% of similar trials
Trial Design
2 Treatment Groups
SPI-1005 400 mg BID
1 of 2
Placebo
1 of 2
Experimental Treatment
Non-Treatment Group
200 Total Participants · 2 Treatment Groups
Primary Treatment: Ebselen · Has Placebo Group · Phase 3
SPI-1005 400 mg BID
Drug
Experimental Group · 1 Intervention: Ebselen · Intervention Types: DrugPlacebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: DrugTreatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ebselen
Not yet FDA approved
Trial Logistics
Trial Timeline
Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 84 days
Closest Location: Michigan Ear Institute · Farmington Hills, MI
2011First Recorded Clinical Trial
0 TrialsResearching Vertigo, Aural
5 CompletedClinical Trials
Who is running the clinical trial?
Sound Pharmaceuticals, IncorporatedLead Sponsor
11 Previous Clinical Trials
874 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 4 Total Inclusion Criteria
Mark “yes” if the following statements are true for you:You are an adult male or female, 18-75 years of age at the time of enrollment.
You have hearing loss of 30 dB or more at 250, 500, or 1000 Hz at study enrollment.
You have two or more active symptoms of Meniere's disease within 3 months of study enrollment.
About The Reviewer
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
References
- Kil, Jonathan, E. Emily Harruff, and Ryan J. Longenecker. 2022. “Development of Ebselen for the Treatment of Sensorineural Hearing Loss and Tinnitus”. Hearing Research. Elsevier BV. doi:10.1016/j.heares.2021.108209.
- Kil, Jonathan, Edward Lobarinas, Christopher Spankovich, Scott K Griffiths, Patrick J Antonelli, Eric D Lynch, and Colleen G Le Prell. 2017. “Safety and Efficacy of Ebselen for the Prevention of Noise-induced Hearing Loss: A Randomised, Double-blind, Placebo-controlled, Phase 2 Trial”. The Lancet. Elsevier BV. doi:10.1016/s0140-6736(17)31791-9.
- Kil, Jonathan, Carol Pierce, Huy Tran, Rende Gu, and Eric D. Lynch. 2007. “Ebselen Treatment Reduces Noise Induced Hearing Loss via the Mimicry and Induction of Glutathione Peroxidase”. Hearing Research. Elsevier BV. doi:10.1016/j.heares.2006.08.006.
- Kil, Jonathan, E. Emily Harruff, and Ryan J. Longenecker. 2022. “Development of Ebselen for the Treatment of Sensorineural Hearing Loss and Tinnitus”. Hearing Research. Elsevier BV. doi:10.1016/j.heares.2021.108209.
- Kil, Jonathan, E. Emily Harruff, and Ryan J. Longenecker. 2022. “Development of Ebselen for the Treatment of Sensorineural Hearing Loss and Tinnitus”. Hearing Research. Elsevier BV. doi:10.1016/j.heares.2021.108209.
- 2022. "SPI-1005 for the Treatment of Meniere's Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04677972.
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