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
TRIPLE
Enrollment
400
Double-blind treatment period of 17 weeks up to 75 mg Neramexane mesylate per day, 12 weeks follow-up.
Double-blind treatment period of 17 weeks placebo, 12 weeks follow-up.
TBF-12 (Tinnitus-Beeinträchtigungs-Fragebogen-12 "Tinnitus Handycap Inventory-12") total score change from baseline to end of treatment
Time frame: Screening, Baseline, week 5, 13, 17
TBF-12 factorial scores, individual respond rate, Tinnitus Rating Scale, Sleep Questionnaire, Qualitiy Of Life, population pharmacokinetics, optional pharmacogenetics
Time frame: 29 weeks
safety parameters
Time frame: 29 weeks
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AZ Sint Lucas, ENT department
Assebroek-Brugge, Belgium
University Hospital Brussels, ENT department
Brussels, Belgium
Clinique Universitaire Saint-Luc
Brussels, Belgium
Dr. Henri HABERMAN
Brussels, Belgium
AZ Sint Lucas, ENT department
Ghent, Belgium
Centre hospitalier de jolimont
La Louvière, Belgium
University Hospital Leuven, ENT Department
Leuven, Belgium
CHU Liege Service ORL
Liège, Belgium
Medico
Chodov, Prague, Czechia
Prof. MUDr. Ivo Šlapák, CSc
Brno, Czechia
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