Study design and patients
ototoxic, anxiety, acute hearing loss, perforation, COVID-19 infection, tinnitus, traumatic, head or neck injury, Tinnitus, hearing loss, depression, barotrauma, Meniere’s disease, trauma
AGE-RELATED HEARING LOSS, EAR DISEASE, AIDS, PULSATILE TINNITUS, POLAND, COVID-19 INFECTION, TINNITUS, OTITIS MEDIA, TINNITUS, HEARING LOSS, MIDDLE EAR
This randomized, double-blind, placebo-controlled, Phase 2 study was conducted in the United States, Germany, Poland, and the United Kingdom. This study was registered on ClinicalTrials.gov (NCT04829214) and conducted in compliance with applicable regulatory requirements, the Declaration of Helsinki, Good Clinical Practice guidelines, and central and local Ethics Committees and Institutional Review Boards. All participants provided written informed consent before enrollment.Eligible patients were male or female aged 18–75 years, inclusive, with subjective unilateral tinnitus. Patients had to be consistently aware of their tinnitus throughout much of the waking day. The tinnitus had to be deemed by the investigator to be likely of cochlear origin (e.g., associated with acute hearing loss from noise trauma, barotrauma, blast trauma, middle ear surgery, age-related hearing loss, resolved otitis media, ototoxic drug exposure) with an onset of tinnitus of 2–12 months prior to signing informed consent. Tinnitus associated with COVID-19 infection or vaccination did not qualify for the study. TFI scores at both Screening and Baseline visits were required to be ≥ 32 for eligibility. Study patients could have audiometrically defined normal hearing or up to moderately severe hearing loss in the affected ear (study ear) as characterized by pure tone average of ≤ 70 dB at 1000, 2000, and 4000 Hz at Screening. Patients had to be able to use a smart phone diary to complete daily tinnitus ratings and complete at least five of the last 7 days of diary entries during the 14-days Lead-in period for eligibility. Exclusion criteria included Meniere’s disease. pulsatile tinnitus, tinnitus resulting from traumatic head or neck injury, any ongoing therapy known to be potentially tinnitus-inducing, severe or untreated depression or anxiety, and systemic or intratympanic steroids within 6 weeks prior to Screening, active middle ear disease including: abnormality or perforation of the tympanic membrane. Stable prior treatments (≥ 1 month prior to Screening) of antidepressant and anti-anxiety medications, over-the-counter supplements or medications for tinnitus, or use of hearing aids, noise generators, sound therapy devices, and any behavioral therapy for tinnitus were allowed but expected to continue for the duration of the study.