Tinnitus treatment – Help at last?

Clinical trails for a new drug to treat tinnitus following acute acoustic trauma or sudden deafness will be carried out soon. Let us keep our fingers crossed they can develop something similar for chronic tinnitus patients who has suffered for longer periods.

Auris Medical today announced the initiation of a phase IIb clinical trial with AM-101, an investigational drug for the treatment of acute inner ear tinnitus

Basel, Switzerland | March 12, 2009 | Auris Medical today announced the initiation of a phase IIb clinical trial with AM-101, an investigational drug for the treatment of acute inner ear tinnitus. The study is designed as a double blind, randomised, placebo-controlled trial with parallel dose groups and will take place in Germany, Belgium and the Netherlands. It will involve about 20 study sites with Prof. Heinz Maier, Ulm (Germany), and Prof. Paul van de Heyning, Antwerp (Belgium), acting as lead investigators. The primary objective of the clinical trial will be to evaluate the efficacy of AM-101 in the treatment of acute inner ear tinnitus. Secondary ob-jectives of the study will be the evaluation of the safety and local tolerance of AM-101 as well as the identification of the optimal dose of AM-101. A first clinical trial in 2007/08 showed that AM-101 is well tolerated and safe, and provided first indications of a therapeutic benefit.

The phase IIb clinical trial with AM-101 will recruit patients suffering from persistent inner ear tinnitus following a documented acute acoustic trauma or sudden deafness incident less than 3 months before. Study participants will receive the medication injected into the middle ear under local anaesthesia of the ear drum. Intratympanic injections are a well established, minimally invasive procedure. Patients will be assessed for their tinnitus, hearing function and various other assessments over a three month period. The primary endpoint of the study will be the change in the tinnitus minimum masking level from baseline to day 90.

SOURCE: Auris Medical

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