MedPath

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

Phase 3
Terminated
Conditions
Subjective Tinnitus
Interventions
Registration Number
NCT00827008
Lead Sponsor
Merz Pharmaceuticals GmbH
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

Detailed Description

Not available

Recruitment & Eligibility

Status
TERMINATED
Sex
All
Target Recruitment
821
Inclusion Criteria
  • 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

Main

Read More
Exclusion Criteria
  • 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.)
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
1, verumNeramexane mesylate-
Primary Outcome Measures
NameTimeMethod
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 parameters54 weeks
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (134)

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

🇺🇸

Kalispell, Montana, United States

Hospital Sagunto

🇪🇸

Sagunto, Valencia, Spain

Heartland Research Associates, LLC.

🇺🇸

Wichita, Kansas, United States

University of Kansas Department of Otolaryngology Head & Neck Surgery

🇺🇸

Kansas City, Kansas, United States

Colorado Otolaryngology Associates

🇺🇸

Colorado Springs, Colorado, United States

University Hospital Leuven, ENT Department

🇧🇪

Leuven, Belgium

Rijnland Ziekenhuis, ENT department

🇳🇱

Leiderdorp, GA, Netherlands

Andromed Rotterdam

🇳🇱

Rotterdam, HC, Netherlands

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

🇵🇱

Krakow, Poland

Andromed Oost

🇳🇱

Velp, ES, Netherlands

AZ Sint Lucas, ENT department

🇧🇪

Gent, Belgium

Medico

🇨🇿

Chodov, Prague, Czech Republic

ORL oddělení, Všeobecná Fakultní Nemocnice v Praze

🇨🇿

Praha, Czech Republic

Unidad Médica de Especialidades del Noroeste (UMEN)

🇲🇽

Centro Culiacán Sinaloa, Mexico

Internal Medicine Clin Trials (IMED)

🇲🇽

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

Monterrey International Research Center (MIRC)

🇲🇽

Nuevo León CP 64000, Mexico

Andromed Leiden

🇳🇱

Leiderdorp, RA, Netherlands

David L. Bortniker, M.D, FACS

🇺🇸

Somerville, New Jersey, United States

Krankenhaus der Elisabethinen

🇦🇹

Graz, Austria

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

🇦🇹

Kufstein, Austria

ORL oddělení , Karlovarská krajská nemocnice a. s.

🇨🇿

Sokolov, Czech Republic

Clinical Research Instutute S.C.

🇲🇽

Edo. de México CP 54055, Mexico

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

🇺🇸

Charleston, South Carolina, United States

University Hospital Brussels

🇧🇪

Brussels, Belgium

Teaching University Hospital, ORL klinika

🇨🇿

Brno, Czech Republic

ORL oddělení, Karlovarská krajská nemocncie a.s.

🇨🇿

Karlovy Vary, Czech Republic

Hospital General de Chihuahua. "Dr. Salvador Anchondo"

🇲🇽

Chihuahua C.P. 31000, Mexico

Hospital Christus Muguerza del Parque

🇲🇽

Chihuahua CP 3100, Mexico

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

🇲🇽

San Luis Potosí, SLP, México, 78240, Mexico

Andromed Zoetermeer

🇳🇱

Zoetermeer, EK, Netherlands

Andromed Breda

🇳🇱

Breda, VL, Netherlands

Szpital Miejski im. J.Brudzinskiego

🇵🇱

Gdynia, Poland

Niepubliczny Zaklad Opieki Zdrowotnej PROMED

🇵🇱

Krakow, Poland

Samodzielny Publiczny Szpital Kliniczny nr 1 we Wroclawiu

🇵🇱

Wroclaw, Poland

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

🇨🇿

Mladá Boleslav, Czech Republic

Paradigm Clinical Research

🇺🇸

Tucson, Arizona, United States

Clin Pharm International GmbH, Zentrum Wien

🇦🇹

Vienna, Austria

Clinique Universitaire Saint-luc

🇧🇪

Bruxelles, Belgium

Oblastní nemocnice Kladno a.s., Nemocnice Středočeského kraje

🇨🇿

Kladno, Czech Republic

Hospital Civil de Guadalajara

🇲🇽

Col. El Retiro CP 44280 Cuadalajara Jalis, Mexico

Grupo Médico Terranova

🇲🇽

CP 44630 Guadalajara Jalisco, Mexico

Instituto Biomédico de Investigación A.C.

🇲🇽

Fracc. Bosques del Prado Norte Aguascalientes, Mexico

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

🇲🇽

Jalisco, 44150, Mexico

Specjalistyczny Gabinet Otolaryngologiczny

🇵🇱

Krakow, Poland

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

🇵🇱

Lodz, Poland

Hospital Militar Regional nº 1 Serviço de Otorrinolaringologia

🇵🇹

Porto, Portugal

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

🇵🇱

Lublin, Poland

Wojewodzki Szpital Specjalistyczny w Olsztynie

🇵🇱

Olsztyn, Poland

Dr. Sarfati

🇫🇷

La seyne sur Mer, France

Prince Alfred House

🇿🇦

Wynberg, South Africa

Clínica OTOSUL

🇧🇷

Valenca/RJ, Brazil

Hopital Nord

🇫🇷

Saint-etienne, France

Wansford and Kings Cliffe Practice

🇬🇧

Petereborough, United Kingdom

Hospital Clínico Barcelona, Dept. Of ORL

🇪🇸

Barcelona, Spain

Louis Leipoldt Mediclinic

🇿🇦

Bellville, South Africa

Fundación Hospital de Alcorcón, Otorhinolaryngology

🇪🇸

Alcorcon - Madrid, Spain

Lakeview Hospital

🇿🇦

Benoni, South Africa

Instytut Fizjologii i Patologii Sluchu

🇵🇱

Warszawa, Poland

1007 Louis Pasteur Building

🇿🇦

Pretoria, South Africa

Constantiaberg Medi Clinic,

🇿🇦

Western Cape, South Africa

GCT Eastmed Clinical Trial centre

🇿🇦

Pretoria, South Africa

Oldfield Surgery

🇬🇧

Bath, United Kingdom

Avondale Surgery, Research Office

🇬🇧

Chesterfield, United Kingdom

Burbage Surgery

🇬🇧

Leicestershire, United Kingdom

Frome Medical Practice

🇬🇧

Somerset, United Kingdom

Hospital Puerta del Hierro, Madrid- Servicio de ORL

🇪🇸

Madrid, Spain

Clínica Universitaria de Navarra, Dept. ORL

🇪🇸

Pamplona, Navarra, Spain

Sherbourne Medical Centre

🇬🇧

Warwickshire, United Kingdom

Hospital Universitario de Salamanca- Hospital Virgen de la Vega

🇪🇸

Salamanca, Spain

Addenbrooke's Hospital

🇬🇧

Cambridge, United Kingdom

The university Hospitals of Leicester, Leicester Royal Infirmary

🇬🇧

Leicester, United Kingdom

The Freeman Hospital

🇬🇧

Newcastle upon Tyne, United Kingdom

Hospital Universitario Príncipe de Asturias

🇪🇸

Madrid, Spain

Central California Clinical Research

🇺🇸

Fresno, California, United States

New West Physicians

🇺🇸

Golden, Colorado, United States

Providence Clinical Research

🇺🇸

Burbank, California, United States

UC Davis Health System Department of Otolaryngology

🇺🇸

Sacramento, California, United States

Knight Center for Integrated Health,

🇺🇸

Peoria, Illinois, United States

Clinical Research of West Florida

🇺🇸

Tampa, Florida, United States

Visions Clinical Research

🇺🇸

Boynton Beach, Florida, United States

Deerpath Physicians Group

🇺🇸

Gurnee, Illinois, United States

Montefiore Medical Center Attn: Anxiety and Depression Center

🇺🇸

Bronx, New York, United States

Erie County Medical Center, Department of Rehabilitation Medicine

🇺🇸

Buffalo, New York, United States

Immedicenter

🇺🇸

Bloomfield, New Jersey, United States

Cary Medical Research

🇺🇸

Cary, North Carolina, United States

Wake Research Associates, LLC

🇺🇸

Raleigh, North Carolina, United States

Wilmington Medical Research

🇺🇸

Wilmington, North Carolina, United States

Piedmont Medical Research

🇺🇸

Winston-Salem, North Carolina, United States

FutureSearch Trials of Dallas

🇺🇸

Dallas, Texas, United States

R/D Clinical Research, Inc.

🇺🇸

Lake Jackson, Texas, United States

South Texas Research Alliance LLC

🇺🇸

Laredo, Texas, United States

Future Search Trials of Neurology

🇺🇸

Austin, Texas, United States

Research Across America

🇺🇸

Plano, Texas, United States

Advanced Clinical Research

🇺🇸

West Jordon, Utah, United States

Health Research of Hampton Roads, Inc.

🇺🇸

Newport News, Virginia, United States

Consultório Dr. Marcelo Rates

🇧🇷

Belo Horizonte/Mimaf Gerais, Brazil

Osmar Clayton Person

🇧🇷

Santo André/SP, Brazil

Instituto Ganz Sanchez

🇧🇷

São Paulo/SP, Brazil

prof. MUDr. Ivo Šlapák

🇨🇿

Brno, Czech Republic

Centre Hospitalier de Bretagne Sud Service ORL-B9

🇫🇷

Lorient, France

Dr. Ebbo

🇫🇷

Issy les moulineaux, France

Dr. Bonfils

🇫🇷

Paris, France

Dr. Ohresser

🇫🇷

Paris, France

Dr. Fraysse

🇫🇷

Toulouse cedex, France

Hopital Paul BROUSSE Polyclinique

🇫🇷

Villejuif, France

Service ORL CHU Bretonneau

🇫🇷

Tours, France

Dr. med. Norbert Pasch

🇩🇪

Aachen, Germany

Dr. Kühne, Elisabeth

🇩🇪

Halle, Saale, Germany

Charité, Universitätsmedizin Berlin-Tinnituszentrum

🇩🇪

Berlin, Germany

Klin. Forschung Berlin Buch GmbH

🇩🇪

Berlin, Germany

Dr. Klaus Peter Jayme

🇩🇪

Darmstadt, Germany

Dr. med. Frank Reintjes

🇩🇪

Braunschweig, Germany

DM Helena Sigal

🇩🇪

Chemnitz, Germany

Dr. Christian Dörr

🇩🇪

Dresden, Germany

HNO-Praxis im Gesundheitszentrum

🇩🇪

Duisburg, Germany

Dr. Gieselmann, Werner

🇩🇪

Heiligenhaus, Germany

Dr. Wolfgang Lotte

🇩🇪

Iserlohn, Germany

Dr. Dr. med. Hans-Detlev Stahl

🇩🇪

Leipzig, Germany

HNO Praxis

🇩🇪

Lichtenfels, Germany

ClinPharm International

🇩🇪

Magdeburg, Germany

Dr. Dannesberger

🇩🇪

Lorsch, Germany

HNO Gemeinschaftpraxis

🇩🇪

Meppen, Germany

Dr. Susanne Wiedemann

🇩🇪

Nuernberg, Germany

Martin Canis, MD

🇩🇪

Munich, Germany

Dr. Norbert Staab

🇩🇪

Schlüchtern, Germany

Dr. med. Ulrike Walter

🇩🇪

Nürnberg, Germany

Dr. Hannelore Neumaier

🇩🇪

Wiesbaden, Germany

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

🇲🇽

Nuevo León CP 64400, Mexico

Adromed Nijmegen

🇳🇱

Nijmegen, HL, Netherlands

Uniwersytecki Szpital Kliniczny w Bialymstoku

🇵🇱

Bialystok, Poland

Niepubliczny Zaklad Opieki Zdrowotnej Prywatne Centrum Medyczne PROMEDIS

🇵🇱

Gdansk, Poland

NZOZ Specjalistyczne Centrum Medyczne Nowomed

🇵🇱

Krakow, Poland

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

🇵🇱

Katowice, Poland

Commonwealth Ear, Nose & Throat

🇺🇸

Louisville, Kentucky, United States

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