The purpose of this study is to investigate the safety and efficacy of neramexane mesylate in the treatment of subjective tinnitus in comparison to placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
411
Double-blind treatment period of 17 weeks up to 75 mg Neramexane mesylate per day
Double-blind treatment period of 17 weeks placebo
TBF-12 (Tinnitus-Beeinträchtigungs-Fragebogen-12 "Tinnitus Handicap Inventory-12") total score change from baseline to end of treatment
Time frame: Screening, Baseline, week 5, 13, 17
TBF-12 factorial scores, individual responder rate, Tinnitus Rating Scale, Sleep Questionnaire, population pharmacokinetics, optional pharmacogenetics
Time frame: 17 weeks
safety parameters
Time frame: 17 weeks
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Krankenhaus der Elisabethinen
Graz, Austria
Bezirkskrankenhaus Kufstein
Kufstein, Austria
A. ö. Krankenhaus der Elisabethinen Linz
Linz, Austria
Salzburger Landeskrankenhaus, Universitätsklinik für Hals-Nasen-Ohren-Krankheiten
Salzburg, Austria
Clin Pharm International GmbH, Zentrum Wien
Vienna, Austria
Dr. Elisabeth Kühne
Halle, Saale, Germany
Dr. med. Nobert Pasch
Aachen, Germany
Dr. Peter Küppers
Augsburg, Germany
Charité, Universitätsmedizin Berlin-Tinnituszentrum
Berlin, Germany
Klin. Forschung Berlin Buch GmbH
Berlin, Germany
...and 44 more locations