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

NCT00827008 | Terminated Phase 3

• 2 other identifiers: MRZ 92579/TI/30042008-001432-13
• Study Type: interventional
• Target: 821
• Locations: 14 countries
• Sites: 135

Brief Summary

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

Conditions

Subjective Tinnitus

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

1, verum

EXPERIMENTAL

Drug: Neramexane mesylate

Interventions

Neramexane mesylate DRUG

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

1, verum

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients who have successfully completed one of the double-blind Phase 3 tinnitus studies of Merz with Neramexane mesylate
• patients aged equal or older 18 but not older than 75 years with clinical diagnosis of first onset, persistent (i.e. tinnitus should never be absent for more than 24 hours in a row), subjective, uni-or bilateral subacute tinnitus at the timepoint of the lead-in study

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Merz Pharmaceuticals GmbH: lead

Study Sites (135)

Paradigm Clinical Research

Tucson, Arizona, 85705, United States

Location

Providence Clinical Research

Burbank, California, 91505, United States

Location

Central California Clinical Research

Fresno, California, 93720, United States

Location

UC Davis Health System Department of Otolaryngology

Sacramento, California, 95817, United States

Location

Colorado Otolaryngology Associates

Colorado Springs, Colorado, 80909, United States

Location

New West Physicians

Golden, Colorado, 80401, United States

Location

Visions Clinical Research

Boynton Beach, Florida, 33472, United States

Location

Clinical Research of West Florida

Tampa, Florida, 33603, United States

Location

Deerpath Physicians Group

Gurnee, Illinois, 60031, United States

Location

Knight Center for Integrated Health,

Peoria, Illinois, 61614, United States

Location

University of Kansas Department of Otolaryngology Head & Neck Surgery

Kansas City, Kansas, 66160-0001, United States

Location

Heartland Research Associates, LLC.

Wichita, Kansas, 67205, United States

Location

Heartland Research Associates, LLC.

Wichita, Kansas, 67207, United States

Location

Commonwealth Ear, Nose & Throat

Louisville, Kentucky, 40207, United States

Location

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

Kalispell, Montana, 59901, United States

Location

Immedicenter

Bloomfield, New Jersey, 07003, United States

Location

David L. Bortniker, M.D, FACS

Somerville, New Jersey, 08876, United States

Location

Erie County Medical Center, Department of Rehabilitation Medicine

Buffalo, New York, 14221, United States

Location

Montefiore Medical Center Attn: Anxiety and Depression Center

The Bronx, New York, 10867, United States

Location

Cary Medical Research

Cary, North Carolina, 27518, United States

Location

Wake Research Associates, LLC

Raleigh, North Carolina, 27612, United States

Location

Wilmington Medical Research

Wilmington, North Carolina, 28401, United States

Location

Piedmont Medical Research

Winston-Salem, North Carolina, 27103, United States

Location

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

Charleston, South Carolina, 29425-5500, United States

Location

Future Search Trials of Neurology

Austin, Texas, 78756, United States

Location

FutureSearch Trials of Dallas

Dallas, Texas, 75231, United States

Location

R/D Clinical Research, Inc.

Lake Jackson, Texas, 77566, United States

Location

South Texas Research Alliance LLC

Laredo, Texas, 78041, United States

Location

Research Across America

Plano, Texas, 75093, United States

Location

Advanced Clinical Research

West Jordon, Utah, 84088, United States

Location

Health Research of Hampton Roads, Inc.

Newport News, Virginia, 23606, United States

Location

Krankenhaus der Elisabethinen

Graz, 8020, Austria

Location

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

Kufstein, 6330, Austria

Location

Clin Pharm International GmbH, Zentrum Wien

Vienna, 1090, Austria

Location

University Hospital Brussels

Brussels, 1090, Belgium

Location

Clinique Universitaire Saint-luc

Brussels, 1200, Belgium

Location

AZ Sint Lucas, ENT department

Ghent, 9000, Belgium

Location

University Hospital Leuven, ENT Department

Leuven, 3000, Belgium

Location

Consultório Dr. Marcelo Rates

Belo Horizonte/Mimaf Gerais, CEP 30150-270, Brazil

Location

Osmar Clayton Person

Santo André/SP, zip 09060-650, Brazil

Location

Instituto Ganz Sanchez

São Paulo/SP, ZIP CODE: 05469-000, Brazil

Location

Clínica OTOSUL

Valenca/RJ, CEP.: 27211-130, Brazil

Location

Medico

Chodov, Prague, 4, Czechia

Location

prof. MUDr. Ivo Šlapák

Brno, 602 00, Czechia

Location

Teaching University Hospital, ORL klinika

Brno, 65691, Czechia

Location

ORL oddělení, Karlovarská krajská nemocncie a.s.

Karlovy Vary, 360 66, Czechia

Location

Oblastní nemocnice Kladno a.s., Nemocnice Středočeského kraje

Kladno, 272 59, Czechia

Location

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

Mladá Boleslav, 29301, Czechia

Location

ORL oddělení, Všeobecná Fakultní Nemocnice v Praze

Prague, 128 08, Czechia

Location

ORL oddělení , Karlovarská krajská nemocnice a. s.

Sokolov, 356 01, Czechia

Location

Dr. Ebbo

Issy-les-Moulineaux, 92130, France

Location

Dr. Sarfati

La Seyne-sur-Mer, 83500, France

Location

Centre Hospitalier de Bretagne Sud Service ORL-B9

Lorient, 2233-56322, France

Location

Dr. Bonfils

Paris, 75015, France

Location

Dr. Ohresser

Paris, 75015, France

Location

Hopital Nord

Saint-Etienne, 42055, France

Location

Dr. Fraysse

Toulouse, 31059, France

Location

Service ORL CHU Bretonneau

Tours, 37044, France

Location

Hopital Paul BROUSSE Polyclinique

Villejuif, 94800, France

Location

Dr. Kühne, Elisabeth

Halle, Saale, 06112, Germany

Location

Dr. med. Norbert Pasch

Aachen, 52074, Germany

Location

Charité, Universitätsmedizin Berlin-Tinnituszentrum

Berlin, 10117, Germany

Location

Klin. Forschung Berlin Buch GmbH

Berlin, 13125, Germany

Location

Dr. med. Frank Reintjes

Braunschweig, 38100, Germany

Location

DM Helena Sigal

Chemnitz, 09120, Germany

Location

Dr. Klaus Peter Jayme

Darmstadt, 64283, Germany

Location

Dr. Christian Dörr

Dresden, 01277, Germany

Location

HNO-Praxis im Gesundheitszentrum

Duisburg, 47179, Germany

Location

Dr. Gieselmann, Werner

Heiligenhaus, 42579, Germany

Location

Dr. Wolfgang Lotte

Iserlohn, 58642, Germany

Location

Dr. Dr. med. Hans-Detlev Stahl

Leipzig, 04103, Germany

Location

HNO Praxis

Lichtenfels, 96215, Germany

Location

Dr. Dannesberger

Lorsch, 64653, Germany

Location

ClinPharm International

Magdeburg, 39104, Germany

Location

HNO Gemeinschaftpraxis

Meppen, 48716, Germany

Location

Martin Canis, MD

Munich, 81377, Germany

Location

Dr. med. Ulrike Walter

Nuremberg, 90402, Germany

Location

Dr. Susanne Wiedemann

Nuremberg, 90443, Germany

Location

Dr. Norbert Staab

Schlüchtern, 36381, Germany

Location

Dr. Hannelore Neumaier

Wiesbaden, 65183, Germany

Location

Unidad Médica de Especialidades del Noroeste (UMEN)

Centro Culiacán Sinaloa, 80000, Mexico

Location

Hospital General de Chihuahua. "Dr. Salvador Anchondo"

Chihuahua C.P. 31000, Mexico

Location

Hospital Christus Muguerza del Parque

Chihuahua CP 3100, Mexico

Location

Internal Medicine Clin Trials (IMED)

Col Obispado, Monterrey , N.L. C.P. 64060, Mexico

Location

Hospital Civil de Guadalajara

Col. El Retiro CP 44280 Cuadalajara Jalis, Mexico

Location

Grupo Médico Terranova

CP 44630 Guadalajara Jalisco, Mexico

Location

Clinical Research Instutute S.C.

Edo. de México CP 54055, Mexico

Location

Instituto Biomédico de Investigación A.C.

Fracc. Bosques Del Prado Norte Aguascalientes, CP 20127, Mexico

Location

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

Jalisco, Mexico

Location

Monterrey International Research Center (MIRC)

Nuevo León CP 64000, Mexico

Location

Hospital Universitario Dr. José Eleuterio González. Edificio Elizondo Barragán, Servicio de Otorrinolaringología

Nuevo León CP 64400, Mexico

Location

Hospital Central "Dr. Ignacio Morones Prieto" Servicio de Otorrinolaringología

San Luis Potosí, SLP, México, 78240, Mexico

Location

Andromed Zoetermeer

Zoetermeer, EK, 2724, Netherlands

Location

Andromed Oost

Velp, ES, 6883, Netherlands

Location

Rijnland Ziekenhuis, ENT department

Leiderdorp, GA, 2353, Netherlands

Location

Andromed Rotterdam

Rotterdam, HC, 3021, Netherlands

Location

Adromed Nijmegen

Nijmegen, HL, 6533, Netherlands

Location

Andromed Leiden

Leiderdorp, RA, 2352, Netherlands

Location

Andromed Breda

Breda, VL, 4811, Netherlands

Location

Uniwersytecki Szpital Kliniczny w Bialymstoku

Bialystok, 15-276, Poland

Location

Niepubliczny Zaklad Opieki Zdrowotnej Prywatne Centrum Medyczne PROMEDIS

Gdansk, 80-288, Poland

Location

Szpital Miejski im. J.Brudzinskiego

Gdynia, 81-348, Poland

Location

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

Katowice, 40-027, Poland

Location

NZOZ Specjalistyczne Centrum Medyczne Nowomed

Krakow, 30-349, Poland

Location

Niepubliczny Zaklad Opieki Zdrowotnej PROMED

Krakow, 31- 636, Poland

Location

Specjalistyczny Gabinet Otolaryngologiczny

Krakow, 31-534, Poland

Location

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

Krakow, 31-913, Poland

Location

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

Lodz, 91-153, Poland

Location

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

Lublin, 20-718, Poland

Location

Wojewodzki Szpital Specjalistyczny w Olsztynie

Olsztyn, 10-561, Poland

Location

Instytut Fizjologii i Patologii Sluchu

Warsaw, 01-943, Poland

Location

Samodzielny Publiczny Szpital Kliniczny nr 1 we Wroclawiu

Wroclaw, 50-369, Poland

Location

Hospital Militar Regional nº 1 Serviço de Otorrinolaringologia

Porto, 4050-113, Portugal

Location

Louis Leipoldt Mediclinic

Bellville, 7530, South Africa

Location

Lakeview Hospital

Benoni, 1501, South Africa

Location

1007 Louis Pasteur Building

Pretoria, 0002, South Africa

Location

GCT Eastmed Clinical Trial centre

Pretoria, 0186, South Africa

Location

Constantiaberg Medi Clinic,

Western Cape, 7800, South Africa

Location

Prince Alfred House

Wynberg, 7800, South Africa

Location

Hospital Sagunto

Sagunto, Valencia, 46520, Spain

Location

Fundación Hospital de Alcorcón, Otorhinolaryngology

Alcorcon - Madrid, 28922, Spain

Location

Hospital Clínico Barcelona, Dept. Of ORL

Barcelona, 08036, Spain

Location

Hospital Puerta del Hierro, Madrid- Servicio de ORL

Madrid, 28035, Spain

Location

Hospital Universitario Príncipe de Asturias

Madrid, 28805, Spain

Location

Clínica Universitaria de Navarra, Dept. ORL

Pamplona, Navarra, 31008, Spain

Location

Hospital Universitario de Salamanca- Hospital Virgen de la Vega

Salamanca, 37007, Spain

Location

Oldfield Surgery

Bath, BA2 3HT, United Kingdom

Location

Addenbrooke's Hospital

Cambridge, CB2 2QQ, United Kingdom

Location

Avondale Surgery, Research Office

Chesterfield, S40 4TF, United Kingdom

Location

The university Hospitals of Leicester, Leicester Royal Infirmary

Leicester, LE1 5WW, United Kingdom

Location

Burbage Surgery

Leicestershire, LE10 2SE, United Kingdom

Location

The Freeman Hospital

Newcastle upon Tyne, NE7 7DN, United Kingdom

Location

Wansford and Kings Cliffe Practice

Petereborough, PE8 6PL, United Kingdom

Location

Frome Medical Practice

Somerset, BA11 1EZ, United Kingdom

Location

Sherbourne Medical Centre

Warwickshire, CV32 4RA, United Kingdom

Location

MeSH Terms

Conditions

Tinnitus

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Medical Expert

  Merz Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2009
• First Posted: January 22, 2009
• Study Start: January 1, 2009
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: November 28, 2012

Record last verified: 2012-11

Locations

GB (9); PT (1); ME (12); AU (3); CZ (8); DE (21); ZA (6); FR (9); BR (4); PL (13); NL (7); ES (7); US (31); BE (4)