Study design
TNF-α, SSHL, tinnitus
HEARING IMPAIRMENT, TINNITUS
This was a randomized, double-blind, multi-center, placebo-controlled, parallel-group phase II proof-of-concept study on efficacy, safety, and tolerability comparing ancrod with placebo (2:1 randomization) as primary treatment in patients with unilateral SSHL. The study was initiated in 19 German and 5 Czech sites. Thereof, in 8 sites patients were enrolled. Treatment and assessments were performed in an outpatient setting including 7 visits and a study duration for each patient of 90 days.The primary outcome measure was the change in pure tone audiogram air conduction thresholds in the affected ear from screening/day 1 until day 8. The pure tone average (PTA) was calculated as the arithmetic mean of air conduction thresholds at affected consecutive frequencies within 0.125, 0.25, 0.5, 1, 2, 4, 6, and 8 kHz. A non-affected frequency within two affected frequencies was included. Secondary outcome measures included: change in speech audiometry, fibrinogen concentration, biomarkers (TNF-α, CD38+ , CD40+ cells), patient and physician assessment of change in hearing impairment, and tinnitus severity.