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*Department of ENT, Head and Neck Surgery, Antwerp University Hospital, Antwerp, Belgium; †Department of ENT, Head and Neck Surgery, German Armed Forces Hospital Ulm, Ulm, Germany; ‡Department of ENT, Head and Neck Surgery, Virga Jesse Hospital, Hasselt, Belgium; §Medical University of Silesia, Katowice; ∥Dept. of Otolaryngology, Medical University of Warsaw, Warsaw, Poland; and ¶Auris Medical AG, Basel, Switzerland.
Published: April 2014
AI Article Synopsis
Article Abstract
Objective: To evaluate the efficacy and safety of intratympanic AM-101 in patients with persistent acute inner ear tinnitus after acute acoustic trauma, idiopathic sudden sensorineural hearing loss (ISSNHL), or acute otitis media.
Study Design: Prospective, double-blind, randomized, placebo-controlled study with follow-up visits on Days 7, 30, and 90.
Setting: Twenty-eight European sites (academic tertiary referral centers and private ENT practices).
Patients: 248 patients aged 16 to 65 years.
Interventions: Three intratympanic injections of AM-101 (0.27 or 0.81 mg/ml) or placebo over 3 consecutive days.
Main Outcome Measures: Efficacy was assessed by changes in minimum masking level (MML; primary end point), loudness match, tinnitus loudness, tinnitus annoyance, and sleep difficulties on a 0 to 100 numerical rating scale, THI-12 questionnaire, and patient global impression of change. Safety was evaluated using the frequency of clinically relevant hearing deterioration and adverse events.
Results: The study overall failed to demonstrate a treatment benefit based on the change in MML. However, AM-101 0.81 mg/ml showed statistically significantly better improvement for tinnitus loudness, annoyance, sleep difficulties, and tinnitus impact in patients with tinnitus after noise trauma or otitis media. The subgroup of ISSNHL-related tinnitus patients did not show conclusive results. The study drug and I.T. injections were well tolerated.
Conclusion: The study established proof of concept for AM-101 in the treatment of tinnitus arising from cochlear glutamate excitotoxicity. Patient-reported outcomes seem to be more relevant and reliable efficacy measures for assessing treatment-related changes in tinnitus than psychoacoustic tests.
