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Brexanolone for Tinnitus
Study Summary
This trial will test a new drug to see if it's safe and tolerable for people with tinnitus, given in a single 6-hour IV infusion.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2021 Phase 3 trial • 28 Patients • NCT03665038Trial Design
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- You have a serious and uncontrolled health condition affecting your liver, kidneys, heart, lungs, stomach, blood, immune system, or metabolism. If you have stable treatment for an underactive thyroid, you can still participate.You are allergic to progesterone, allopregnanolone, or any ingredients in the study medication.You have been experiencing ringing in your ears for at least 6 months but less than 10 years.You have mild to severe distress from ringing in your ears, as measured by a special test.You have a history of sleep apnea or other serious breathing problems that could cause low oxygen levels during the treatment.You plan to start or stop any kind of therapy for tinnitus during the study.You have significant hearing loss in one or both ears, or use a hearing aid or cochlear implant.You have had chronic ear infections more than three times a year for the past five years.You score 15 or more on the Patient Health Questionnaire-9 (PHQ-9) at your screening.You have a moderate or severe problem with using drugs or alcohol within the past year, or test positive for drugs or alcohol before starting the study.You have shown signs of wanting to harm yourself or have a history of doing so within the past 2 years.Your tinnitus can be changed by moving your jaw, head, neck, eyes, or limbs, or is caused by problems with feeling touch or has had surgeries for ear problems.You have a history of any neurological conditions or diseases, like seizures or head injuries with lasting effects.You have donated blood or lost a lot of blood within the last 60 days.You have had constant ringing in your ears for at least 6 months, but not longer than 5 years, and it's not because of another medical condition.You have a moderate to severe level of distress from tinnitus, as measured by a specific test.
- Group 1: Brexanolone
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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 seniors able to join this experiment?
"This study seeks volunteers of legal age, that is to say those older than 18 and younger than 65."
Are enrollees currently being accepted for this research program?
"This clinical trial, which was initially opened for recruitment on May 10th 2023 and recently updated on the 15th of May, is still recruiting patients."
How many participants are being enrolled in this research endeavor?
"Affirmative. The clinical trial is still recruiting, as evidenced by the information on clinicaltrials.gov which shows it was first posted on May 10th 2023 and last updated 15 days later. 24 individuals are expected to partake from a single site."
What is the current regulatory status of Brexanolone?
"There is some evidence of Brexanolone's safety, so it was assigned a 2 on our rating scale. However, there are no current studies that demonstrate its effectiveness for this treatment."
Who has the prerequisites to be admitted into this trial?
"This clinical trial is recruiting 24 individuals with tinnitus between the legal age of consent to 65 years old. To qualify for this study, participants must have a companion driver on the day they visit the clinic, be in good physical health (excluding tinnitus), and possess non-pulsatile idiopathic unilateral or bilateral subjective tinnitus lasting 6 months to 5 years. Furthermore, those who are accepted should exhibit mild to severe distress regarding their condition according to Tinnitus Handicap Inventory scores from 24 - 68 at screening and agree not to take any CNS depressants such as opioids & benzodiazepines, antidepressants"
Who else is applying?
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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