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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT Number 2007-007835-16 |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neramexane mesylate | Drug | Double-blind treatment period of 17 weeks up to 75 mg Neramexane mesylate per day |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| TBF-12 factorial scores, individual responder rate, Tinnitus Rating Scale, Sleep Questionnaire, population pharmacokinetics, optional pharmacogenetics | 17 weeks | |
| safety parameters | 17 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Krankenhaus der Elisabethinen | Graz | A-8020 | Austria | |||
| Bezirkskrankenhaus Kufstein |
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| Label | URL |
|---|---|
| Related Info | View source |
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| Placebo | Drug | Double-blind treatment period of 17 weeks placebo |
|
| Kufstein |
| A-6330 |
| Austria |
| A. ö. Krankenhaus der Elisabethinen Linz | Linz | A-4010 | Austria |
| Salzburger Landeskrankenhaus, Universitätsklinik für Hals-Nasen-Ohren-Krankheiten | Salzburg | A-5020 | Austria |
| Clin Pharm International GmbH, Zentrum Wien | Vienna | A-1090 | Austria |
| Dr. Elisabeth Kühne | Halle | Saale | 06112 | Germany |
| Dr. med. Nobert Pasch | Aachen | 52074 | Germany |
| Dr. Peter Küppers | Augsburg | 86199 | Germany |
| Charité, Universitätsmedizin Berlin-Tinnituszentrum | Berlin | 10117 | Germany |
| Klin. Forschung Berlin Buch GmbH | Berlin | 13125 | Germany |
| Dr. med. Frank Reintjes | Braunschweig | 38100 | Germany |
| ClinPharm International | Chemnitz | 09120 | Germany |
| Dr. Klaus Peter Jayme | Darmstadt | 64283 | Germany |
| Dr. Christian Dörr | Dresden | 01277 | Germany |
| HNO-Praxis im Gesundheitszentrum Walsum | Duisburg | 47179 | Germany |
| ClinPharm International GmbH | Frankfurt | 60596 | Germany |
| ClinPharm International GmbH | Görlitz | 02826 | Germany |
| Dr. Werner Gieselmann | Heiligenhaus | 42579 | Germany |
| Dr. Wolfgang Lotte | Iserlohn | 58642 | Germany |
| ClinPharm International GmbH | Leipzig | 04103 | Germany |
| HNO Praxis | Lichtenfels | 96215 | Germany |
| Dr. Dannesberger | Lorsch | 64653 | Germany |
| ClinPharm International | Magdeburg | 39104 | Germany |
| HNO Gemeinschaftpraxis | Meppen | 48716 | Germany |
| LMU München Klinik Großhadern | Munich | Germany |
| Dr. med. Ulrike Walter | Nuremberg | 90402 | Germany |
| Dr. Susanne Wiedemann | Nuremberg | 90443 | Germany |
| Dr. Norbert Staab | Schlüchtern | 36381 | Germany |
| Dr. Hannelore Neumaier | Wiesbaden | 65183 | Germany |
| Dr. med. Stephanie Göbel | Worms | 67547 | Germany |
| Hospital Militar Regional nº 1 Serviço de Otorrinolaringologia | Porto | 4050-113 | Portugal |
| Clínica ORL Dr. Eurico de Almeida | Porto | 4050-115 | Portugal |
| Clínica Universitaria de Navarra, Dept. ORL | Pamplona | Navarre | 31008 | Spain |
| Hospital Sagunto | Sagunto | Valencia | 46520 | Spain |
| Fundación Hospital de Alcorcón, Otorhinolaryngology | Alcorcón - Madrid | 28922 | Spain |
| Hospital Clínico Barcelona, Dept. Of ORL | Barcelona | 08036 | Spain |
| Clinica Clivina, Private Consultancy | Jaén | Spain |
| Hospital Comarcal San Agustin | Linares, Jaén | 23700 | Spain |
| Hospital Xeral-Calde | Lugo | Spain |
| Hospital Puerta del Hierro, Madrid- Servicio de OR | Madrid | 28035 | Spain |
| Hospital Universitario Príncipe de Asturias | Madrid | 28805 | Spain |
| Hospital Universtiario Son Dureta | Palma de Mallorca | 07004 | Spain |
| Hospital Universitario de Salamanca- Hospital Virgen de la Vega | Salamanca | 37007 | Spain |
| Hospital Universitario Virgen del Rocio- Centro de Especialidades Dr. Fleming | Seville | 41005 | Spain |
| Oldfield Surgery | Bath | BA2 3HT | United Kingdom |
| Avondale Surgery Research office | Chesterfield | S40 4TF | United Kingdom |
| The Horsley Medical Practice | East Horsley, Leatherhead, Surrey | KT24 6QT | United Kingdom |
| The university Hospitals of Leicester, Leicester Royal Infirmary | Leicester | LE1 5WW | United Kingdom |
| Burbage Surgery | Leicestershire | LE10 2SE | United Kingdom |
| The Freeman Hospital | Newcastle upon Tyne | NE7 7DN | United Kingdom |
| Wansford and Kings Cliffe Practice | Petereborough | PE8 6PL | United Kingdom |
| Frome Medical Practice | Somerset | BA11 1EZ | United Kingdom |
| Dr. Trevor Gooding | Warwick Shire | CV9 1EU | United Kingdom |
| Sherbourne Medical Centre | Warwickshire | CV32 4RA | United Kingdom |
| ID | Term |
|---|---|
| D014012 | Tinnitus |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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