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SPI-1005 for Meniere's Disease (STOPMD-3 Trial)
STOPMD-3 Trial 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).
STOPMD-3 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSTOPMD-3 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2019 Phase 2 trial • 149 Patients • NCT03325790STOPMD-3 Trial Design
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Who is running the clinical trial?
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- You have hearing loss of 30 dB or more at 250, 500, or 1000 Hz at study enrollment.I have hearing loss that is not solely due to nerve damage.I have used IV medications that can affect hearing within the last 60 days.I have used steroids in the past 30 days.I have had symptoms like ringing in ears, ear fullness, or dizziness due to Meniere's disease recently.I have had major surgery on my middle or inner ear.I have a history of ear bone growth or inner ear tumors.I do not have major heart, lung, liver, kidney, blood, stomach, hormone, immune system, brain, or mental health issues.I have been diagnosed with Meniere's Disease according to the AAO-HNS 2015 criteria.I am between 18 and 75 years old.I have used ear steroids within the last week.
- Group 1: Placebo
- Group 2: SPI-1005 400 mg BID
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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."
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."
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."
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."
Who else is applying?
What state do they live in?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
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