Title
Efficacy and safety of AM-101 in the treatment of acute inner ear tinnitus : a double-blind, randomized, placebo-controlled phase II study Efficacy and safety of AM-101 in the treatment of acute inner ear tinnitus : a double-blind, randomized, placebo-controlled phase II study
Author
Faculty/Department
Faculty of Medicine and Health Sciences
Publication type
article
Publication
Philadelphia, Pa. ,
Subject
Human medicine
Source (journal)
Otology and neurotology. - Philadelphia, Pa.
Volume/pages
35(2014) :4 , p. 589-597
ISSN
1531-7129
ISI
000333390700011
Carrier
E
Target language
English (eng)
Full text (Publishers DOI)
Affiliation
University of Antwerp
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.
Full text (open access)
https://repository.uantwerpen.be/docman/irua/28419f/7489.pdf
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