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Clinical Trial
. 2007 Sep;127(9):938-42.
doi: 10.1080/00016480601110212.

Intratympanic Treatment of Acute Acoustic Trauma With a Cell-Permeable JNK Ligand: A Prospective Randomized Phase I/II Study

Affiliations
Clinical Trial

Intratympanic Treatment of Acute Acoustic Trauma With a Cell-Permeable JNK Ligand: A Prospective Randomized Phase I/II Study

M Suckfuell et al. Acta Otolaryngol. .

Abstract

Objectives: Intratympanic administration of a cell-permeable JNK ligand has been shown to prevent hearing loss after acute acoustic trauma in animal models.

Conclusions: Functional and morphological analysis of the treated ears revealed that AM-111 had an excellent otoprotective effect, even when administered hours after the noise exposure. Blocking the signal pathway with D-JNKI-1 is therefore a promising way to protect the morphological integrity and physiological function of the inner ear in various conditions involving acute sensorineural hearing loss.

Subjects and methods: For the first application of AM-111 in humans, we organized a clinical phase I/II trial in patients with acute acoustic trauma after exposure to firecrackers in Berlin and Munich on New Year's Eve 2005/2006. We randomly selected 11 patients for intratympanic treatment with AM-111 at a concentration of 0.4 mg/ml or 2 mg/ml within 24 h after noise exposure. Pure tone audiometry and otoacoustic emissions were assessed before treatment and on days 3 and 30 thereafter.

Results: Based on clinical experience and on a calculation using an empirically derived exponential hearing recovery function AM-111 seems to have had a therapeutic effect. A total of 13 adverse events were reported in 5 study participants. None of the adverse events were serious or severe.

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