Efficacy, Safety and Tolerability of Neramexane in Patients With Subjective Tinnitus
- Registration Number
- NCT00739635
- 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
- 411
- Patients aged 18 to 75 years with a clinical diagnosis of first onset,
- Persistent (i.e. tinnitus should never be absent for > 24 hours in a row), subjective, uni- or bilateral tinnitus present for at least 3 months but not more than 12 months
- Clinical diagnosis of intermittent or pulsatile tinnitus
- Patients who have tinnitus as a concomitant symptom of an otological/neurological disease (such as otitis media, Menière's disease, otosclerosis, etc)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Neramexane mesylate - 2 Placebo -
- Primary Outcome Measures
Name Time Method TBF-12 (Tinnitus-Beeinträchtigungs-Fragebogen-12 "Tinnitus Handicap Inventory-12") total score change from baseline to end of treatment Screening, Baseline, week 5, 13, 17
- Secondary Outcome Measures
Name Time Method safety parameters 17 weeks TBF-12 factorial scores, individual responder rate, Tinnitus Rating Scale, Sleep Questionnaire, population pharmacokinetics, optional pharmacogenetics 17 weeks
Trial Locations
- Locations (51)
The Horsley Medical Practice
🇬🇧East Horsley, Leatherhead, Surrey, United Kingdom
Hospital Universitario Príncipe de Asturias
🇪🇸Madrid, Spain
HNO-Praxis im Gesundheitszentrum Walsum
🇩🇪Duisburg, Germany
Dr. Wolfgang Lotte
🇩🇪Iserlohn, Germany
Hospital Universtiario Son Dureta
🇪🇸Palma de Mallorca, Spain
HNO Praxis
🇩🇪Lichtenfels, Germany
Clinica Clivina, Private Consultancy
🇪🇸Jaén, Spain
Dr. med. Nobert Pasch
🇩🇪Aachen, Germany
Krankenhaus der Elisabethinen
🇦🇹Graz, Austria
Charité, Universitätsmedizin Berlin-Tinnituszentrum
🇩🇪Berlin, Germany
The university Hospitals of Leicester, Leicester Royal Infirmary
🇬🇧Leicester, United Kingdom
Fundación Hospital de Alcorcón, Otorhinolaryngology
🇪🇸Alcorcón - Madrid, Spain
Dr. Werner Gieselmann
🇩🇪Heiligenhaus, Germany
Dr. Susanne Wiedemann
🇩🇪Nürnberg, Germany
Avondale Surgery Research office
🇬🇧Chesterfield, United Kingdom
Dr. Peter Küppers
🇩🇪Augsburg, Germany
Dr. med. Frank Reintjes
🇩🇪Braunschweig, Germany
ClinPharm International GmbH
🇩🇪Leipzig, Germany
Dr. Dannesberger
🇩🇪Lorsch, Germany
Hospital Xeral-Calde
🇪🇸Lugo, Spain
Wansford and Kings Cliffe Practice
🇬🇧Petereborough, United Kingdom
Hospital Comarcal San Agustin
🇪🇸Linares, Jaén, Spain
Hospital Clínico Barcelona, Dept. Of ORL
🇪🇸Barcelona, Spain
Sherbourne Medical Centre
🇬🇧Warwickshire, United Kingdom
Clínica Universitaria de Navarra, Dept. ORL
🇪🇸Pamplona, Navarra, Spain
ClinPharm International
🇩🇪Magdeburg, Germany
Dr. Klaus Peter Jayme
🇩🇪Darmstadt, Germany
A. ö. Krankenhaus der Elisabethinen Linz
🇦🇹Linz, Austria
Clin Pharm International GmbH, Zentrum Wien
🇦🇹Vienna, Austria
Salzburger Landeskrankenhaus, Universitätsklinik für Hals-Nasen-Ohren-Krankheiten
🇦🇹Salzburg, Austria
Klin. Forschung Berlin Buch GmbH
🇩🇪Berlin, Germany
Dr. Elisabeth Kühne
🇩🇪Halle, Saale, Germany
LMU München Klinik Großhadern
🇩🇪Munich, Germany
Hospital Puerta del Hierro, Madrid- Servicio de OR
🇪🇸Madrid, Spain
Oldfield Surgery
🇬🇧Bath, United Kingdom
Burbage Surgery
🇬🇧Leicestershire, United Kingdom
The Freeman Hospital
🇬🇧Newcastle upon Tyne, United Kingdom
Frome Medical Practice
🇬🇧Somerset, United Kingdom
Dr. Trevor Gooding
🇬🇧Warwick Shire, United Kingdom
Dr. Christian Dörr
🇩🇪Dresden, Germany
Dr. med. Stephanie Göbel
🇩🇪Worms, Germany
Dr. Norbert Staab
🇩🇪Schlüchtern, Germany
Dr. Hannelore Neumaier
🇩🇪Wiesbaden, Germany
Hospital Universitario de Salamanca- Hospital Virgen de la Vega
🇪🇸Salamanca, Spain
Hospital Universitario Virgen del Rocio- Centro de Especialidades Dr. Fleming
🇪🇸Sevilla, Spain
Dr. med. Ulrike Walter
🇩🇪Nürnberg, Germany
HNO Gemeinschaftpraxis
🇩🇪Meppen, Germany
Bezirkskrankenhaus Kufstein
🇦🇹Kufstein, Austria
Clínica ORL Dr. Eurico de Almeida
🇵🇹Porto, Portugal
Hospital Militar Regional nº 1 Serviço de Otorrinolaringologia
🇵🇹Porto, Portugal
Hospital Sagunto
🇪🇸Sagunto, Valencia, Spain