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New treatment option for Tinnitus, Noise Induced
Official title TNF-α Treatment of Blast-Induced Tinnitus
ClinicalTrials.gov ID: NCT04066348
What this study is testing
What is Etanercept?
Etanercept is an investigational medicine, being studied as a potential treatment for tinnitus, noise induced.
Also referred to as Enbrel.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this multi-site research study is to determine if Etanercept, compared to a placebo, significantly reduces the severity of tinnitus (ringing in the ears) associated with history of blast and/or noise exposure or associated with Traumatic Brain Injury (TBI) and/or concussion. Individuals who qualify will be randomized into one of two groups: The group receiving the medication Etanercept or the group receiving a saline solution placebo.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Tinnitus of at least a moderate severity as defined by a score of ≥ 25 points or higher on the Tinnitus Functional Index (TFI) questionnaire...
- Blast- or noise exposure
- Traumatic brain injury (TBI) and/or concussion diagnosed by a health care provider.
- Able to provide written informed consent.
- Age: Minimum 18 years of age at the time of enrollment.
You likely can't join if
- History or evidence of any of the following: Significant brain malformation; cerebral vascular events (such as strokes); neurodegenerative disorders...
- Active malignant neoplasm such as lymphoma or solid tumors or history of malignant neoplasm, excluding successfully treated squamous cell carcinoma...
- Diagnosis of congestive heart failure.
- History of diagnosed seizure disorder or epilepsy.
- Diagnosis of myelodysplastic syndrome or aplastic anemia, white blood cell count \< 4000, or platelet count \< 150,000.
- people who currently have an active infection, including tuberculosis, HIV, hepatitis B, and/or chicken pox. a. Patients with latent hepatitis B...
See the full eligibility criteria
- Tinnitus of at least a moderate severity as defined by a score of ≥ 25 points or higher on the Tinnitus Functional Index (TFI) questionnaire associated with one or more of the following:
- Blast- or noise exposure
- Traumatic brain injury (TBI) and/or concussion diagnosed by a health care provider.
- Able to provide written informed consent.
- Age: Minimum 18 years of age at the time of enrollment.
- Other concurrent treatments for tinnitus: A four-week washout from any other tinnitus treatment or management program is required prior to entering this study. a) Hearing aids are permitted if the participant has been...
- Hearing function: All degrees of hearing function can be included, recognizing that individuals with profound, bilateral hearing loss will not be able to perform tinnitus evaluations and hearing tests but will be able...
- Additional tinnitus characteristics: a) Tinnitus history: Onset associated with blast and/or noise exposure or associated with diagnosed TBI and/or concussion. people will have blast exposure, noise exposure, traumatic...
- History or evidence of any of the following: Significant brain malformation; cerebral vascular events (such as strokes); neurodegenerative disorders affecting the brain, such as Parkinson's disease, ALS, or Huntington's...
- Active malignant neoplasm such as lymphoma or solid tumors or history of malignant neoplasm, excluding successfully treated squamous cell carcinoma or basal carcinoma of the skin or cervical cancer.
- Diagnosis of congestive heart failure.
- History of diagnosed seizure disorder or epilepsy.
- Diagnosis of myelodysplastic syndrome or aplastic anemia, white blood cell count \< 4000, or platelet count \< 150,000.
- people who currently have an active infection, including tuberculosis, HIV, hepatitis B, and/or chicken pox. a. Patients with latent hepatitis B infection are also excluded from participation.
- Scheduled to receive a live vaccine during study participation or received a live vaccine within 2 weeks prior to screening visit/procedures.
- Diagnosis of an auto-immune disease that, in the opinion of the investigator, would cause a weakened immune system. a) Autoimmune thyroid disease is not considered an exclusionary autoimmune disease for participation in...
- Diabetes.
- Ongoing treatment with or plans to begin taking any of the following contraindicated medications: Cyclophosphamide or sulfasalazine; abatacept, anakinra, or any other immunomodulatory biologic therapy; sulfonylureas...
- people who cannot communicate reliably with research team members or who are not likely to be able to complete the requirements of the trial per the discretion of the investigator.
- people who have participated in a drug clinical trial within the last 30 days before the start of this one.
- Pregnancy or planned pregnancy during the study.
- Women who are lactating or are of child-bearing-age without use of contraception.
- MMSE score \< 24.
- Clinically significant out of range laboratory values for protocol required laboratory tests as assessed by the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Celebration, Florida, United States
- Coral Gables, Florida, United States
- Detroit, Michigan, United States
- Farmington Hills, Michigan, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Celebration, Florida, United States; Coral Gables, Florida, United States; Detroit, Michigan, United States; Farmington Hills, Michigan, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.