Efficacy, Safety and Tolerability of Neramexane in Comparison to Placebo in Patients With Subjective Tinnitus
- Registration Number
- NCT00772980
- Lead Sponsor
- Merz Pharmaceuticals GmbH
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 400
Inclusion Criteria
- patients aged 18 to 75 years with a clinical diagnosis of first onset, persistent (i.e. tinnitus sghould never be absent for >24 hours in a row), subjective, uni-or bilateral tinntius present for at least 3 months but not more than 12 months.
Exclusion Criteria
- Clinical diagnosis of intermittent or pulsatile tinnitus
- Patients who have tinnitus as a concomitant symptom of an otological/neurological disease(such as otitis media, Meniére´s disease, otosclerosis, etc.)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Neramexane mesylate Drug: Neramexa mesylate Double-blind treatment period of 17 weeks up to 75 mg Neramexane mesylate per day 2 Placebo Drug: Placebo Double-blind treatment period of 17 weeks placebo
- Primary Outcome Measures
Name Time Method TBF-12 (Tinnitus-Beeinträchtigungs-Fragebogen-12 "Tinnitus Handycap Inventory-12") total score change from baseline to end of treatment Screening, Baseline, week 5, 13, 17
- Secondary Outcome Measures
Name Time Method TBF-12 factorial scores, individual respond rate, Tinnitus Rating Scale, Sleep Questionnaire, Qualitiy Of Life, population pharmacokinetics, optional pharmacogenetics 29 weeks safety parameters 29 weeks
Trial Locations
- Locations (54)
AZ Sint Lucas, ENT department
🇧🇪Gent, Belgium
University Hospital Brussels, ENT department
🇧🇪Brussels, Belgium
Clinique Universitaire Saint-Luc
🇧🇪Brussels, Belgium
Dr. Henri HABERMAN
🇧🇪Bruxelles, Belgium
Centre hospitalier de jolimont
🇧🇪La Louvière, Belgium
University Hospital Leuven, ENT Department
🇧🇪Leuven, Belgium
CHU Liege Service ORL
🇧🇪Liège, Belgium
Medico
🇨🇿Chodov, Prague, Czech Republic
Prof. MUDr. Ivo Šlapák, CSc
🇨🇿Brno, Czech Republic
Teaching University Hospital, ORL klinika
🇨🇿Brno, Czech Republic
Scroll for more (44 remaining)AZ Sint Lucas, ENT department🇧🇪Gent, Belgium