Auris Medical expects interim analysis of TRAVERS Phase 2 trial in Q4 or 1Q20
Started enrollment of the TRAVERS Phase 2 trial with AM-125 in acute vertigo. In late July 2019, the Company announced that the first patient had been randomized in the TRAVERS Phase 2 trial. TRAVERS will enroll 138 patients that suffer from acute vertigo following surgical removal of a vestibular schwannoma, a tumor growing behind the inner ear. In Part A of the trial, five ascending doses of AM-125 or placebo, administered three times daily over a total of four weeks, will be tested in a total of 50 patients. In addition, oral betahistine 48 mg will be tested in 16 patients under open-label conditions for reference. Based on an interim analysis, which is expected for the fourth quarter of 2019 or the first quarter of 2020, two doses will be selected and tested in an estimated 72 patients in Part B.