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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-001432-13 | EudraCT Number |
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The purpose of this study is to investigate the long-term safety and tolerability and efficacy of neramexane mesylate in the long-term treatment of subjective tinnitus after a completed double-blind randomized placebo controlled study
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1, verum | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neramexane mesylate | Drug | Up-titration treatment period of 5 weeks up to 75mg Neramexane mesylate oral per day followed by 49 weeks treatment maintenance |
|
| Measure | Description | Time Frame |
|---|---|---|
| Descriptive analyses of TBF-12 (Tinnitus-Beeinträchtigungs-Fragebogen 12 "Tinnitus Handicap Inventory 12")total score and its subscores, of the Tinnitus Rating Scale and its single items as well as of SF-36 and safety/tolerability parameters | 54 weeks |
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Main Inclusion Criteria:
Main Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Expert | Merz Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Paradigm Clinical Research | Tucson | Arizona | 85705 | United States | ||
| Providence Clinical Research |
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| Burbank |
| California |
| 91505 |
| United States |
| Central California Clinical Research | Fresno | California | 93720 | United States |
| UC Davis Health System Department of Otolaryngology | Sacramento | California | 95817 | United States |
| Colorado Otolaryngology Associates | Colorado Springs | Colorado | 80909 | United States |
| New West Physicians | Golden | Colorado | 80401 | United States |
| Visions Clinical Research | Boynton Beach | Florida | 33472 | United States |
| Clinical Research of West Florida | Tampa | Florida | 33603 | United States |
| Deerpath Physicians Group | Gurnee | Illinois | 60031 | United States |
| Knight Center for Integrated Health, | Peoria | Illinois | 61614 | United States |
| University of Kansas Department of Otolaryngology Head & Neck Surgery | Kansas City | Kansas | 66160-0001 | United States |
| Heartland Research Associates, LLC. | Wichita | Kansas | 67205 | United States |
| Heartland Research Associates, LLC. | Wichita | Kansas | 67207 | United States |
| Commonwealth Ear, Nose & Throat | Louisville | Kentucky | 40207 | United States |
| Glacier Ear, Nose, and Throat, Head and Neck Surgery, P.C. | Kalispell | Montana | 59901 | United States |
| Immedicenter | Bloomfield | New Jersey | 07003 | United States |
| David L. Bortniker, M.D, FACS | Somerville | New Jersey | 08876 | United States |
| Erie County Medical Center, Department of Rehabilitation Medicine | Buffalo | New York | 14221 | United States |
| Montefiore Medical Center Attn: Anxiety and Depression Center | The Bronx | New York | 10867 | United States |
| Cary Medical Research | Cary | North Carolina | 27518 | United States |
| Wake Research Associates, LLC | Raleigh | North Carolina | 27612 | United States |
| Wilmington Medical Research | Wilmington | North Carolina | 28401 | United States |
| Piedmont Medical Research | Winston-Salem | North Carolina | 27103 | United States |
| Medical University of South Carolina - Department of Otolaryngology, Department of Otolaryngology - Head & Neck Surgery | Charleston | South Carolina | 29425-5500 | United States |
| Future Search Trials of Neurology | Austin | Texas | 78756 | United States |
| FutureSearch Trials of Dallas | Dallas | Texas | 75231 | United States |
| R/D Clinical Research, Inc. | Lake Jackson | Texas | 77566 | United States |
| South Texas Research Alliance LLC | Laredo | Texas | 78041 | United States |
| Research Across America | Plano | Texas | 75093 | United States |
| Advanced Clinical Research | West Jordon | Utah | 84088 | United States |
| Health Research of Hampton Roads, Inc. | Newport News | Virginia | 23606 | United States |
| Krankenhaus der Elisabethinen | Graz | 8020 | Austria |
| Bezirkskrankenhaus Kufstein Dr. Christof Pauli (PI: Prim. Dr. Peter Ostertag | Kufstein | 6330 | Austria |
| Clin Pharm International GmbH, Zentrum Wien | Vienna | 1090 | Austria |
| University Hospital Brussels | Brussels | 1090 | Belgium |
| Clinique Universitaire Saint-luc | Brussels | 1200 | Belgium |
| AZ Sint Lucas, ENT department | Ghent | 9000 | Belgium |
| University Hospital Leuven, ENT Department | Leuven | 3000 | Belgium |
| Consultório Dr. Marcelo Rates | Belo Horizonte/Mimaf Gerais | CEP 30150-270 | Brazil |
| Osmar Clayton Person | Santo André/SP | zip 09060-650 | Brazil |
| Instituto Ganz Sanchez | São Paulo/SP | ZIP CODE: 05469-000 | Brazil |
| Clínica OTOSUL | Valenca/RJ | CEP.: 27211-130 | Brazil |
| Medico | Chodov | Prague | 4 | Czechia |
| prof. MUDr. Ivo Šlapák | Brno | 602 00 | Czechia |
| Teaching University Hospital, ORL klinika | Brno | 65691 | Czechia |
| ORL oddělení, Karlovarská krajská nemocncie a.s. | Karlovy Vary | 360 66 | Czechia |
| Oblastní nemocnice Kladno a.s., Nemocnice Středočeského kraje | Kladno | 272 59 | Czechia |
| Pro-audio,s.r.o.-private ENT clinic | Mladá Boleslav | 29301 | Czechia |
| ORL oddělení, Všeobecná Fakultní Nemocnice v Praze | Prague | 128 08 | Czechia |
| ORL oddělení , Karlovarská krajská nemocnice a. s. | Sokolov | 356 01 | Czechia |
| Dr. Ebbo | Issy-les-Moulineaux | 92130 | France |
| Dr. Sarfati | La Seyne-sur-Mer | 83500 | France |
| Centre Hospitalier de Bretagne Sud Service ORL-B9 | Lorient | 2233-56322 | France |
| Dr. Bonfils | Paris | 75015 | France |
| Dr. Ohresser | Paris | 75015 | France |
| Hopital Nord | Saint-Etienne | 42055 | France |
| Dr. Fraysse | Toulouse | 31059 | France |
| Service ORL CHU Bretonneau | Tours | 37044 | France |
| Hopital Paul BROUSSE Polyclinique | Villejuif | 94800 | France |
| Dr. Kühne, Elisabeth | Halle | Saale | 06112 | Germany |
| Dr. med. Norbert Pasch | Aachen | 52074 | Germany |
| Charité, Universitätsmedizin Berlin-Tinnituszentrum | Berlin | 10117 | Germany |
| Klin. Forschung Berlin Buch GmbH | Berlin | 13125 | Germany |
| Dr. med. Frank Reintjes | Braunschweig | 38100 | Germany |
| DM Helena Sigal | Chemnitz | 09120 | Germany |
| Dr. Klaus Peter Jayme | Darmstadt | 64283 | Germany |
| Dr. Christian Dörr | Dresden | 01277 | Germany |
| HNO-Praxis im Gesundheitszentrum | Duisburg | 47179 | Germany |
| Dr. Gieselmann, Werner | Heiligenhaus | 42579 | Germany |
| Dr. Wolfgang Lotte | Iserlohn | 58642 | Germany |
| Dr. Dr. med. Hans-Detlev Stahl | Leipzig | 04103 | Germany |
| HNO Praxis | Lichtenfels | 96215 | Germany |
| Dr. Dannesberger | Lorsch | 64653 | Germany |
| ClinPharm International | Magdeburg | 39104 | Germany |
| HNO Gemeinschaftpraxis | Meppen | 48716 | Germany |
| Martin Canis, MD | Munich | 81377 | 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 |
| Unidad Médica de Especialidades del Noroeste (UMEN) | Centro Culiacán Sinaloa | 80000 | Mexico |
| Hospital General de Chihuahua. "Dr. Salvador Anchondo" | Chihuahua C.P. 31000 | Mexico |
| Hospital Christus Muguerza del Parque | Chihuahua CP 3100 | Mexico |
| Internal Medicine Clin Trials (IMED) | Col Obispado, Monterrey , N.L. C.P. 64060 | Mexico |
| Hospital Civil de Guadalajara | Col. El Retiro CP 44280 Cuadalajara Jalis | Mexico |
| Grupo Médico Terranova | CP 44630 Guadalajara Jalisco | Mexico |
| Clinical Research Instutute S.C. | Edo. de México CP 54055 | Mexico |
| Instituto Biomédico de Investigación A.C. | Fracc. Bosques Del Prado Norte Aguascalientes | CP 20127 | Mexico |
| Unidad de Investigación Clínica Cardiometábolica de Occidente S.C. (UNICAMO) | Jalisco | Mexico |
| Monterrey International Research Center (MIRC) | Nuevo León CP 64000 | Mexico |
| Hospital Universitario Dr. José Eleuterio González. Edificio Elizondo Barragán, Servicio de Otorrinolaringología | Nuevo León CP 64400 | Mexico |
| Hospital Central "Dr. Ignacio Morones Prieto" Servicio de Otorrinolaringología | San Luis Potosí, SLP, México, 78240 | Mexico |
| Andromed Zoetermeer | Zoetermeer | EK | 2724 | Netherlands |
| Andromed Oost | Velp | ES | 6883 | Netherlands |
| Rijnland Ziekenhuis, ENT department | Leiderdorp | GA | 2353 | Netherlands |
| Andromed Rotterdam | Rotterdam | HC | 3021 | Netherlands |
| Adromed Nijmegen | Nijmegen | HL | 6533 | Netherlands |
| Andromed Leiden | Leiderdorp | RA | 2352 | Netherlands |
| Andromed Breda | Breda | VL | 4811 | Netherlands |
| Uniwersytecki Szpital Kliniczny w Bialymstoku | Bialystok | 15-276 | Poland |
| Niepubliczny Zaklad Opieki Zdrowotnej Prywatne Centrum Medyczne PROMEDIS | Gdansk | 80-288 | Poland |
| Szpital Miejski im. J.Brudzinskiego | Gdynia | 81-348 | Poland |
| Samodzielny Publiczny Szpital Kliniczny im. Andrzeja Mieleckiego Slaskiego Uniwersytetu Medycznego w Katowicach | Katowice | 40-027 | Poland |
| NZOZ Specjalistyczne Centrum Medyczne Nowomed | Krakow | 30-349 | Poland |
| Niepubliczny Zaklad Opieki Zdrowotnej PROMED | Krakow | 31- 636 | Poland |
| Specjalistyczny Gabinet Otolaryngologiczny | Krakow | 31-534 | Poland |
| Szpital Specjalistyczny im. Stefana Zeromskiego, SP ZOZ w Krakowie, Oddzial Otolaryngologii | Krakow | 31-913 | Poland |
| Samodzielny Publiczny Zaklad Opieki Zdrowotnej, Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi | Lodz | 91-153 | Poland |
| Wojewodzki Szpital Specjalistyczny im. Stefana Kardynała Wyszynskiego Samodzielny Publiczny Zaklad Opieki Zdrowotnej | Lublin | 20-718 | Poland |
| Wojewodzki Szpital Specjalistyczny w Olsztynie | Olsztyn | 10-561 | Poland |
| Instytut Fizjologii i Patologii Sluchu | Warsaw | 01-943 | Poland |
| Samodzielny Publiczny Szpital Kliniczny nr 1 we Wroclawiu | Wroclaw | 50-369 | Poland |
| Hospital Militar Regional nº 1 Serviço de Otorrinolaringologia | Porto | 4050-113 | Portugal |
| Louis Leipoldt Mediclinic | Bellville | 7530 | South Africa |
| Lakeview Hospital | Benoni | 1501 | South Africa |
| 1007 Louis Pasteur Building | Pretoria | 0002 | South Africa |
| GCT Eastmed Clinical Trial centre | Pretoria | 0186 | South Africa |
| Constantiaberg Medi Clinic, | Western Cape | 7800 | South Africa |
| Prince Alfred House | Wynberg | 7800 | South Africa |
| Hospital Sagunto | Sagunto | Valencia | 46520 | Spain |
| Fundación Hospital de Alcorcón, Otorhinolaryngology | Alcorcon - Madrid | 28922 | Spain |
| Hospital Clínico Barcelona, Dept. Of ORL | Barcelona | 08036 | Spain |
| Hospital Puerta del Hierro, Madrid- Servicio de ORL | Madrid | 28035 | Spain |
| Hospital Universitario Príncipe de Asturias | Madrid | 28805 | Spain |
| Clínica Universitaria de Navarra, Dept. ORL | Pamplona, Navarra | 31008 | Spain |
| Hospital Universitario de Salamanca- Hospital Virgen de la Vega | Salamanca | 37007 | Spain |
| Oldfield Surgery | Bath | BA2 3HT | United Kingdom |
| Addenbrooke's Hospital | Cambridge | CB2 2QQ | United Kingdom |
| Avondale Surgery, Research Office | Chesterfield | S40 4TF | 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 |
| 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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