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Selenium-containing molecule

Ebselen for Meniere's Disease

Medical University of South Carolina, Charleston, SC

Targeting 2 different conditionsEbselen +1 morePhase 3Waitlist AvailableResearch Sponsored by Sound Pharmaceuticals, Incorporated

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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.

Be older than 18 years old

Must not have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up84 days

Awards & highlights

Pivotal Trial

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).

Eligible Conditions

Meniere's Disease
Ménière's Disease

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below

Select...

You have experienced at least two out of three common symptoms of Meniere's disease (ringing in the ears, feeling of fullness in the ears, and dizziness or spinning sensation) within the past three months before starting the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 84 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~84 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 84 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Words-in-Noise Test score

Change in low frequency hearing thresholds measured by pure tone audiometry

Incidence of Treatment-Emergent Adverse Events

Secondary outcome measures

Change in aural fullness

Change in dizziness

Change in tinnitus loudness

+2 more

Side effects data

From 2019 Phase 2 trial • 149 Patients • NCT03325790

12%

Blood triglycerides increased

Alanine aminotransferase increased

Gamma-glutamyltransferase increased

Upper respiratory tract infection

100%

80%

60%

40%

20%

Study treatment Arm

200mg SPI-1005 Twice Daily (BID)

Placebo

400mg SPI-1005 BID

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: SPI-1005 400 mg BIDExperimental Treatment1 Intervention

Oral administration of SPI-1005 400 mg BID for 28 days, with 84-day followup

Group II: PlaceboPlacebo Group1 Intervention

Oral administration of matching placebo BID for 28 days, with 84-day followup

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ebselen

Not yet FDA approved

0 / 1Eligibility criteria met

Find a site

Who is running the clinical trial?

Sound Pharmaceuticals, IncorporatedLead Sponsor

11 Previous Clinical Trials

874 Total Patients Enrolled

Media Library

Ebselen (Selenium-containing molecule) Clinical Trial Eligibility Overview. Trial Name: NCT04677972 — Phase 3

Meniere's Disease Research Study Groups: SPI-1005 400 mg BID, Placebo

Meniere's Disease Clinical Trial 2023: Ebselen Highlights & Side Effects. Trial Name: NCT04677972 — Phase 3

Ebselen (Selenium-containing molecule) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04677972 — Phase 3

Meniere's Disease Patient Testimony for trial: Trial Name: NCT04677972 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there several hospitals running this trial in the metropolitan area?

"Currently, this study is enrolling patients from a total of 24 sites. While some of the locations are in Farmington Hills, Maywood and San Francisco, others are more dispersed. If you are interested in participating, it may be best to choose a location that is close to you to avoid extensive travel."

Answered by AI

Are participants being actively recruited for this experiment as of now?

"The listed clinical trial on clinicaltrials.gov is currently recruiting patients. This specific trial was posted on 8/2/2022 and updated on 11/3/2022."

Answered by AI

What are the main objectives of this research project?

"The primary outcome of this 56 day clinical trial, as reported by Sound Pharmaceuticals, Incorporated, is the Incidence of Treatment-Emergent Adverse Events. Additionally, the study will secondary outcomes including Change in tinnitus loudness, Change in aural fullness, and Change in dizziness."

Answered by AI

Could you please summarize the existing Ebselen research?

"Currently, 4 clinical trials for Ebselen are underway. 1 of these trials is in Phase 3. These trials began in Durham, North Carolina but have since expanded to 39 different locations."

Answered by AI

How does Ebselen consumption impact human health?

"Ebselen has been evaluated as a level 3 medication, meaning that while there is data supporting its efficacy, multiple rounds of testing have also confirmed its safety."

Answered by AI

Does this method of research have any precedent?

"Ebselen is being trialed in 23 cities across 2 nations. The first time Ebselen was trialed was in 2021 by Sound Pharmaceuticals, Incorporated. That initial study had 50 patients and completed Phase 1 of the approval process. Since then, 18268 more trials have been conducted."

Answered by AI

Is this research open to people who are above the age of 75 years old?

"The enrolled participants in this particular clinical trial must be aged 18 to 75. There are 1 clinical trials specifically for people who are underage and 20 trials for people who are geriatric."

Answered by AI

Who would be a good candidate to take part in this experiment?

"To be eligible for this clinical trial, patients must suffer from vertigo and aural symptoms. Furthermore, they should be between the ages of 18 and 75. This study will accept a total of 200 individuals."

Answered by AI