Ebselen for Vertigo, Aural

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Michigan Ear Institute, Farmington Hills, MI
Vertigo, Aural+1 More
Ebselen - Drug
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

2 of 3
This is further along than 85% of similar trials

Other trials for Vertigo, Aural

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

3 of 3
This is further along than 85% of similar trials

Other trials for Vertigo, Aural

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: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Treatment
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
Photo of michigan 1Photo of michigan 2Photo of michigan 3
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 preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

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.