Auris Medical completed enrolment of patients for its first clinical trial with AM-101, its investigational drug for the treatment of inner ear tinnitus

DUEDINGEN, Switzerland | January 30, 2008 | Auris Medical completed enrolment of patients for its first clinical trial with AM-101, its investigational drug for the treatment of inner ear tinnitus. A total of 24 patients suffering from tinnitus following acute noise trauma or sudden deafness were administered either AM-101 or placebo by single dose intratympanic injection. Their tinnitus had set in less than three months before treatment and proven to be refractory to a first-line treatment with glucocorticoids.

The primary objective of the double blind, randomised phase I/II trial with dose escalation is to evaluate the safety of intratympanically delivered AM-101 in patients. The secondary objective of the study is a preliminary evaluation of the potential therapeutic benefit of AM-101. The clinical trial with AM-101 is involving four study sites in Germany with Professor Heinz Maier, MD, acting as lead investigator. It will be concluded in two months with the last patient completing the 60 day follow-up period.

SOURCE: Auris Medical

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