TNF-α Treatment of Blast-Induced Tinnitus
ConditionTinnitus, Noise Induced
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorWayne State University
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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 disease; multiple sclerosis, Guillain-Barré syndrome, or any other disease involving demyelination disorder or any finding suggesting a demyelination disease or disorder; prior brain surgery.
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.
Trial design
Treatments tested in this trial
- Etanercept
- Saline
Treatment groups
88 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov