Title
Selecting appropriate dose regimens for AM-101 in the intratympanic treatment of acute inner ear tinnitus Selecting appropriate dose regimens for AM-101 in the intratympanic treatment of acute inner ear tinnitus
Author
Faculty/Department
Faculty of Medicine and Health Sciences
Publication type
article
Publication
Basel ,
Subject
Human medicine
Source (journal)
Audiology and neuro-otology. - Basel
Volume/pages
20(2015) :3 , p. 172-182
ISSN
1420-3030
ISI
000355014500004
Carrier
E
Target language
English (eng)
Full text (Publishers DOI)
Affiliation
University of Antwerp
Abstract
Inhibition of cochlear N-methyl-D-aspartate (NMDA) receptors with AM-101, a small molecule antagonist delivered by intratympanic injection, represents a novel approach to treat acute tinnitus triggered by glutamate excitotoxicity. An earlier double-blind, randomized, placebo-controlled phase II clinical trial (TACTT0) had demonstrated a significant and dose-dependent improvement in tinnitus triggered by acute acoustic trauma or otitis media from baseline to day 90. A second phase II trial (TACTT1) now sought to evaluate the most appropriate dose regimen for this treatment. Outcomes from the TACTT1 trial showed no significant difference in tinnitus improvement between a single-dose treatment and a dose regimen comprising three doses over 2 weeks. Taken together, three injections over 3 consecutive days showed the best results in the two phase II trials, suggesting that repeated and concentrated inhibition of cochlear NMDA receptors provides best treatment effects, while keeping the procedural impact on patients short. (C) 2015 S. Karger AG, Basel
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