Open-Label, Long-Term Treatment Study, to Assess the Long-Term Safety and Tolerability and Efficacy of Neramexane in Patients With Subjective Tinnitus

PHASE3TerminatedINTERVENTIONAL
Enrollment

821

Participants

Timeline

Start Date

January 31, 2009

Primary Completion Date

December 31, 2011

Study Completion Date

December 31, 2011

Conditions
Subjective Tinnitus
Interventions
DRUG

Neramexane mesylate

Up-titration treatment period of 5 weeks up to 75mg Neramexane mesylate oral per day followed by 49 weeks treatment maintenance

Trial Locations (135)

4

Medico, Chodov

1090

Clin Pharm International GmbH, Zentrum Wien, Vienna

University Hospital Brussels, Brussels

1200

Clinique Universitaire Saint-luc, Brussels

1501

Lakeview Hospital, Benoni

2352

Andromed Leiden, Leiderdorp

2353

Rijnland Ziekenhuis, ENT department, Leiderdorp

2724

Andromed Zoetermeer, Zoetermeer

3000

University Hospital Leuven, ENT Department, Leuven

3021

Andromed Rotterdam, Rotterdam

4811

Andromed Breda, Breda

6330

Bezirkskrankenhaus Kufstein Dr. Christof Pauli (PI: Prim. Dr. Peter Ostertag, Kufstein

6533

Adromed Nijmegen, Nijmegen

6883

Andromed Oost, Velp

7530

Louis Leipoldt Mediclinic, Bellville

7800

Constantiaberg Medi Clinic,, Western Cape

Prince Alfred House, Wynberg

8020

Krankenhaus der Elisabethinen, Graz

9000

AZ Sint Lucas, ENT department, Ghent

10117

Charité, Universitätsmedizin Berlin-Tinnituszentrum, Berlin

10867

Montefiore Medical Center Attn: Anxiety and Depression Center, The Bronx

13125

Klin. Forschung Berlin Buch GmbH, Berlin

14221

Erie County Medical Center, Department of Rehabilitation Medicine, Buffalo

23606

Health Research of Hampton Roads, Inc., Newport News

27103

Piedmont Medical Research, Winston-Salem

27518

Cary Medical Research, Cary

27612

Wake Research Associates, LLC, Raleigh

28035

Hospital Puerta del Hierro, Madrid- Servicio de ORL, Madrid

28401

Wilmington Medical Research, Wilmington

28805

Hospital Universitario Príncipe de Asturias, Madrid

28922

Fundación Hospital de Alcorcón, Otorhinolaryngology, Alcorcon - Madrid

29301

Pro-audio,s.r.o.-private ENT clinic, Mladá Boleslav

31008

Clínica Universitaria de Navarra, Dept. ORL, Pamplona, Navarra

31059

Dr. Fraysse, Toulouse

33472

Visions Clinical Research, Boynton Beach

33603

Clinical Research of West Florida, Tampa

36381

Dr. Norbert Staab, Schlüchtern

37007

Hospital Universitario de Salamanca- Hospital Virgen de la Vega, Salamanca

37044

Service ORL CHU Bretonneau, Tours

38100

Dr. med. Frank Reintjes, Braunschweig

39104

ClinPharm International, Magdeburg

40207

Commonwealth Ear, Nose & Throat, Louisville

42055

Hopital Nord, Saint-Etienne

42579

Dr. Gieselmann, Werner, Heiligenhaus

46520

Hospital Sagunto, Sagunto

47179

HNO-Praxis im Gesundheitszentrum, Duisburg

48716

HNO Gemeinschaftpraxis, Meppen

52074

Dr. med. Norbert Pasch, Aachen

58642

Dr. Wolfgang Lotte, Iserlohn

59901

Glacier Ear, Nose, and Throat, Head and Neck Surgery, P.C., Kalispell

60031

Deerpath Physicians Group, Gurnee

61614

Knight Center for Integrated Health,, Peoria

64283

Dr. Klaus Peter Jayme, Darmstadt

64653

Dr. Dannesberger, Lorsch

65183

Dr. Hannelore Neumaier, Wiesbaden

65691

Teaching University Hospital, ORL klinika, Brno

67205

Heartland Research Associates, LLC., Wichita

67207

Heartland Research Associates, LLC., Wichita

75015

Dr. Bonfils, Paris

Dr. Ohresser, Paris

75093

Research Across America, Plano

75231

FutureSearch Trials of Dallas, Dallas

77566

R/D Clinical Research, Inc., Lake Jackson

78041

South Texas Research Alliance LLC, Laredo

78756

Future Search Trials of Neurology, Austin

80000

Unidad Médica de Especialidades del Noroeste (UMEN), Centro Culiacán Sinaloa

80401

New West Physicians, Golden

80909

Colorado Otolaryngology Associates, Colorado Springs

81377

Martin Canis, MD, Munich

83500

Dr. Sarfati, La Seyne-sur-Mer

84088

Advanced Clinical Research, West Jordon

85705

Paradigm Clinical Research, Tucson

90402

Dr. med. Ulrike Walter, Nuremberg

90443

Dr. Susanne Wiedemann, Nuremberg

91505

Providence Clinical Research, Burbank

92130

Dr. Ebbo, Issy-les-Moulineaux

93720

Central California Clinical Research, Fresno

94800

Hopital Paul BROUSSE Polyclinique, Villejuif

95817

UC Davis Health System Department of Otolaryngology, Sacramento

96215

HNO Praxis, Lichtenfels

66160-0001

University of Kansas Department of Otolaryngology Head & Neck Surgery, Kansas City

07003

Immedicenter, Bloomfield

08876

David L. Bortniker, M.D, FACS, Somerville

29425-5500

Medical University of South Carolina - Department of Otolaryngology, Department of Otolaryngology - Head & Neck Surgery, Charleston

CEP 30150-270

Consultório Dr. Marcelo Rates, Belo Horizonte/Mimaf Gerais

zip 09060-650

Osmar Clayton Person, Santo André/SP

ZIP CODE: 05469-000

Instituto Ganz Sanchez, São Paulo/SP

CEP.: 27211-130

Clínica OTOSUL, Valenca/RJ

602 00

prof. MUDr. Ivo Šlapák, Brno

360 66

ORL oddělení, Karlovarská krajská nemocncie a.s., Karlovy Vary

272 59

Oblastní nemocnice Kladno a.s., Nemocnice Středočeského kraje, Kladno

128 08

ORL oddělení, Všeobecná Fakultní Nemocnice v Praze, Prague

356 01

ORL oddělení , Karlovarská krajská nemocnice a. s., Sokolov

2233-56322

Centre Hospitalier de Bretagne Sud Service ORL-B9, Lorient

06112

Dr. Kühne, Elisabeth, Halle

09120

DM Helena Sigal, Chemnitz

01277

Dr. Christian Dörr, Dresden

04103

Dr. Dr. med. Hans-Detlev Stahl, Leipzig

Unknown

"Hospital General de Chihuahua. Dr. Salvador Anchondo", Chihuahua C.P. 31000

Hospital Christus Muguerza del Parque, Chihuahua CP 3100

Internal Medicine Clin Trials (IMED), Col Obispado, Monterrey , N.L. C.P. 64060

Hospital Civil de Guadalajara, Col. El Retiro CP 44280 Cuadalajara Jalis

Grupo Médico Terranova, CP 44630 Guadalajara Jalisco

Clinical Research Instutute S.C., Edo. de México CP 54055

Unidad de Investigación Clínica Cardiometábolica de Occidente S.C. (UNICAMO), Jalisco

Monterrey International Research Center (MIRC), Nuevo León CP 64000

Hospital Universitario Dr. José Eleuterio González. Edificio Elizondo Barragán, Servicio de Otorrinolaringología, Nuevo León CP 64400

"Hospital Central Dr. Ignacio Morones Prieto Servicio de Otorrinolaringología", San Luis Potosí, SLP, México, 78240

CP 20127

Instituto Biomédico de Investigación A.C., Fracc. Bosques Del Prado Norte Aguascalientes

15-276

Uniwersytecki Szpital Kliniczny w Bialymstoku, Bialystok

80-288

Niepubliczny Zaklad Opieki Zdrowotnej Prywatne Centrum Medyczne PROMEDIS, Gdansk

81-348

Szpital Miejski im. J.Brudzinskiego, Gdynia

40-027

Samodzielny Publiczny Szpital Kliniczny im. Andrzeja Mieleckiego Slaskiego Uniwersytetu Medycznego w Katowicach, Katowice

30-349

NZOZ Specjalistyczne Centrum Medyczne Nowomed, Krakow

31- 636

Niepubliczny Zaklad Opieki Zdrowotnej PROMED, Krakow

31-534

Specjalistyczny Gabinet Otolaryngologiczny, Krakow

31-913

Szpital Specjalistyczny im. Stefana Zeromskiego, SP ZOZ w Krakowie, Oddzial Otolaryngologii, Krakow

91-153

Samodzielny Publiczny Zaklad Opieki Zdrowotnej, Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi, Lodz

20-718

Wojewodzki Szpital Specjalistyczny im. Stefana Kardynała Wyszynskiego Samodzielny Publiczny Zaklad Opieki Zdrowotnej, Lublin

10-561

Wojewodzki Szpital Specjalistyczny w Olsztynie, Olsztyn

01-943

Instytut Fizjologii i Patologii Sluchu, Warsaw

50-369

Samodzielny Publiczny Szpital Kliniczny nr 1 we Wroclawiu, Wroclaw

4050-113

Hospital Militar Regional nº 1 Serviço de Otorrinolaringologia, Porto

0002

1007 Louis Pasteur Building, Pretoria

0186

GCT Eastmed Clinical Trial centre, Pretoria

08036

Hospital Clínico Barcelona, Dept. Of ORL, Barcelona

BA2 3HT

Oldfield Surgery, Bath

CB2 2QQ

Addenbrooke's Hospital, Cambridge

S40 4TF

Avondale Surgery, Research Office, Chesterfield

LE1 5WW

The university Hospitals of Leicester, Leicester Royal Infirmary, Leicester

LE10 2SE

Burbage Surgery, Leicestershire

NE7 7DN

The Freeman Hospital, Newcastle upon Tyne

PE8 6PL

Wansford and Kings Cliffe Practice, Petereborough

BA11 1EZ

Frome Medical Practice, Somerset

CV32 4RA

Sherbourne Medical Centre, Warwickshire

Sponsors
All Listed Sponsors
lead

Merz Pharmaceuticals GmbH

INDUSTRY

NCT00827008 - Open-Label, Long-Term Treatment Study, to Assess the Long-Term Safety and Tolerability and Efficacy of Neramexane in Patients With Subjective Tinnitus | Biotech Hunter | Biotech Hunter