Clinical trial NCT00827008: Open-Label, Long-Term Treatment Study, to Assess the Long-Term Safety and Tolerability and Efficacy of Neramexane in Patients With Subjective Tinnitus
Official title: An Open-Label, Long-Term Treatment Study to Assess the Long-Term Safety and Tolerability and Efficacy of Neramexane With Subjective Tinnitus
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Subjective Tinnitus
Lead sponsor: Merz Pharmaceuticals GmbH
Sponsor class: INDUSTRY
First posted: 2009-01-22
Enrollment: 821
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: Main 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 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.)

Primary outcomes:
measure: 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
timeFrame: 54 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Paradigm Clinical Research
state: Arizona
city: Burbank
country: United States
facility: Providence Clinical Research
state: California
city: Fresno
country: United States
facility: Central California Clinical Research
state: California
city: Sacramento
country: United States
facility: UC Davis Health System Department of Otolaryngology
state: California
city: Colorado Springs
country: United States
facility: Colorado Otolaryngology Associates
state: Colorado
city: Golden
country: United States
facility: New West Physicians
state: Colorado
city: Boynton Beach
country: United States
facility: Visions Clinical Research
state: Florida
city: Tampa
country: United States
facility: Clinical Research of West Florida
state: Florida
city: Gurnee
country: United States
facility: Deerpath Physicians Group
state: Illinois
city: Peoria
country: United States
facility: Knight Center for Integrated Health,
state: Illinois
city: Kansas City
country: United States
facility: University of Kansas Department of Otolaryngology Head & Neck Surgery
state: Kansas
city: Wichita
country: United States
facility: Heartland Research Associates, LLC.
state: Kansas
city: Wichita
country: United States
facility: Heartland Research Associates, LLC.
state: Kansas
city: Louisville
country: United States
facility: Commonwealth Ear, Nose & Throat
state: Kentucky
city: Kalispell
country: United States
facility: Glacier Ear, Nose, and Throat, Head and Neck Surgery, P.C.
state: Montana
city: Bloomfield
country: United States
facility: Immedicenter
state: New Jersey
city: Somerville
country: United States
facility: David L. Bortniker, M.D, FACS
state: New Jersey
city: Bronx
country: United States
facility: Montefiore Medical Center Attn: Anxiety and Depression Center
state: New York
city: Buffalo
country: United States
facility: Erie County Medical Center, Department of Rehabilitation Medicine
state: New York
city: Cary
country: United States
facility: Cary Medical Research
state: North Carolina
city: Raleigh
country: United States
facility: Wake Research Associates, LLC
state: North Carolina
city: Wilmington
country: United States
facility: Wilmington Medical Research
state: North Carolina
city: Winston-Salem
country: United States
facility: Piedmont Medical Research
state: North Carolina
city: Charleston
country: United States
facility: Medical University of South Carolina - Department of Otolaryngology, Department of Otolaryngology - Head & Neck Surgery
state: South Carolina
city: Austin
country: United States
facility: Future Search Trials of Neurology
state: Texas
city: Dallas
country: United States
facility: FutureSearch Trials of Dallas
state: Texas
city: Lake Jackson
country: United States
facility: R/D Clinical Research, Inc.
state: Texas
city: Laredo
country: United States
facility: South Texas Research Alliance LLC
state: Texas
city: Plano
country: United States
facility: Research Across America
state: Texas
city: West Jordon
country: United States
facility: Advanced Clinical Research
state: Utah
city: Newport News
country: United States
facility: Health Research of Hampton Roads, Inc.
state: Virginia
city: Graz
country: Austria
facility: Krankenhaus der Elisabethinen
city: Kufstein
country: Austria
facility: Bezirkskrankenhaus Kufstein Dr. Christof Pauli (PI: Prim. Dr. Peter Ostertag
city: Vienna
country: Austria
facility: Clin Pharm International GmbH, Zentrum Wien
city: Brussels
country: Belgium
facility: University Hospital Brussels
city: Bruxelles
country: Belgium
facility: Clinique Universitaire Saint-luc
city: Gent
country: Belgium
facility: AZ Sint Lucas, ENT department
city: Leuven
country: Belgium
facility: University Hospital Leuven, ENT Department
city: Belo Horizonte/Mimaf Gerais
country: Brazil
facility: Consultório Dr. Marcelo Rates
city: Santo André/SP
country: Brazil
facility: Osmar Clayton Person
city: São Paulo/SP
country: Brazil
facility: Instituto Ganz Sanchez
city: Valenca/RJ
country: Brazil
facility: Clínica OTOSUL
city: Chodov
country: Czech Republic
facility: Medico
state: Prague
city: Brno
country: Czech Republic
facility: prof. MUDr. Ivo Šlapák
city: Brno
country: Czech Republic
facility: Teaching University Hospital, ORL klinika
city: Karlovy Vary
country: Czech Republic
facility: ORL oddělení, Karlovarská krajská nemocncie a.s.
city: Kladno
country: Czech Republic
facility: Oblastní nemocnice Kladno a.s., Nemocnice Středočeského kraje
city: Mladá Boleslav
country: Czech Republic
facility: Pro-audio,s.r.o.-private ENT clinic
city: Praha
country: Czech Republic
facility: ORL oddělení, Všeobecná Fakultní Nemocnice v Praze
city: Sokolov
country: Czech Republic
facility: ORL oddělení , Karlovarská krajská nemocnice a. s.
city: Issy les moulineaux
country: France
facility: Dr. Ebbo
city: La seyne sur Mer
country: France
facility: Dr. Sarfati
city: Lorient
country: France
facility: Centre Hospitalier de Bretagne Sud Service ORL-B9
city: Paris
country: France
facility: Dr. Bonfils
city: Paris
country: France
facility: Dr. Ohresser
city: Saint-etienne
country: France
facility: Hopital Nord
city: Toulouse cedex
country: France
facility: Dr. Fraysse
city: Tours
country: France
facility: Service ORL CHU Bretonneau
city: Villejuif
country: France
facility: Hopital Paul BROUSSE Polyclinique
city: Halle
country: Germany
facility: Dr. Kühne, Elisabeth
state: Saale
city: Aachen
country: Germany
facility: Dr. med. Norbert Pasch
city: Berlin
country: Germany
facility: Charité, Universitätsmedizin Berlin-Tinnituszentrum
city: Berlin
country: Germany
facility: Klin. Forschung Berlin Buch GmbH
city: Braunschweig
country: Germany
facility: Dr. med. Frank Reintjes
city: Chemnitz
country: Germany
facility: DM Helena Sigal
city: Darmstadt
country: Germany
facility: Dr. Klaus Peter Jayme
city: Dresden
country: Germany
facility: Dr. Christian Dörr
city: Duisburg
country: Germany
facility: HNO-Praxis im Gesundheitszentrum
city: Heiligenhaus
country: Germany
facility: Dr. Gieselmann, Werner
city: Iserlohn
country: Germany
facility: Dr. Wolfgang Lotte
city: Leipzig
country: Germany
facility: Dr. Dr. med. Hans-Detlev Stahl
city: Lichtenfels
country: Germany
facility: HNO Praxis
city: Lorsch
country: Germany
facility: Dr. Dannesberger
city: Magdeburg
country: Germany
facility: ClinPharm International
city: Meppen
country: Germany
facility: HNO Gemeinschaftpraxis
city: Munich
country: Germany
facility: Martin Canis, MD
city: Nuernberg
country: Germany
facility: Dr. Susanne Wiedemann
city: Nürnberg
country: Germany
facility: Dr. med. Ulrike Walter
city: Schlüchtern
country: Germany
facility: Dr. Norbert Staab
city: Wiesbaden
country: Germany
facility: Dr. Hannelore Neumaier
city: Centro Culiacán Sinaloa
country: Mexico
facility: Unidad Médica de Especialidades del Noroeste (UMEN)
city: Chihuahua C.P. 31000
country: Mexico
facility: Hospital General de Chihuahua. "Dr. Salvador Anchondo"
city: Chihuahua CP 3100
country: Mexico
facility: Hospital Christus Muguerza del Parque
city: Col Obispado, Monterrey , N.L. C.P. 64060
country: Mexico
facility: Internal Medicine Clin Trials (IMED)
city: Col. El Retiro CP 44280 Cuadalajara Jalis
country: Mexico
facility: Hospital Civil de Guadalajara
city: CP 44630 Guadalajara Jalisco
country: Mexico
facility: Grupo Médico Terranova
city: Edo. de México CP 54055
country: Mexico
facility: Clinical Research Instutute S.C.
city: Fracc. Bosques del Prado Norte Aguascalientes
country: Mexico
facility: Instituto Biomédico de Investigación A.C.
city: Jalisco, 44150
country: Mexico
facility: Unidad de Investigación Clínica Cardiometábolica de Occidente S.C. (UNICAMO)
city: Nuevo León CP 64000
country: Mexico
facility: Monterrey International Research Center (MIRC)
city: Nuevo León CP 64400
country: Mexico
facility: Hospital Universitario Dr. José Eleuterio González. Edificio Elizondo Barragán, Servicio de Otorrinolaringología
city: San Luis Potosí, SLP, México, 78240
country: Mexico
facility: Hospital Central "Dr. Ignacio Morones Prieto" Servicio de Otorrinolaringología
city: Zoetermeer
country: Netherlands
facility: Andromed Zoetermeer
state: EK
city: Velp
country: Netherlands
facility: Andromed Oost
state: ES
city: Leiderdorp
country: Netherlands
facility: Rijnland Ziekenhuis, ENT department
state: GA
city: Rotterdam
country: Netherlands
facility: Andromed Rotterdam
state: HC
city: Nijmegen
country: Netherlands
facility: Adromed Nijmegen
state: HL
city: Leiderdorp
country: Netherlands
facility: Andromed Leiden
state: RA
city: Breda
country: Netherlands
facility: Andromed Breda
state: VL
city: Bialystok
country: Poland
facility: Uniwersytecki Szpital Kliniczny w Bialymstoku
city: Gdansk
country: Poland
facility: Niepubliczny Zaklad Opieki Zdrowotnej Prywatne Centrum Medyczne PROMEDIS
city: Gdynia
country: Poland
facility: Szpital Miejski im. J.Brudzinskiego
city: Katowice
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny im. Andrzeja Mieleckiego Slaskiego Uniwersytetu Medycznego w Katowicach
city: Krakow
country: Poland
facility: NZOZ Specjalistyczne Centrum Medyczne Nowomed
city: Krakow
country: Poland
facility: Niepubliczny Zaklad Opieki Zdrowotnej PROMED
city: Krakow
country: Poland
facility: Specjalistyczny Gabinet Otolaryngologiczny
city: Krakow
country: Poland
facility: Szpital Specjalistyczny im. Stefana Zeromskiego, SP ZOZ w Krakowie, Oddzial Otolaryngologii
city: Lodz
country: Poland
facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej, Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi
city: Lublin
country: Poland
facility: Wojewodzki Szpital Specjalistyczny im. Stefana Kardynała Wyszynskiego Samodzielny Publiczny Zaklad Opieki Zdrowotnej
city: Olsztyn
country: Poland
facility: Wojewodzki Szpital Specjalistyczny w Olsztynie
city: Warszawa
country: Poland
facility: Instytut Fizjologii i Patologii Sluchu
city: Wroclaw
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny nr 1 we Wroclawiu
city: Porto
country: Portugal
facility: Hospital Militar Regional nº 1 Serviço de Otorrinolaringologia
city: Bellville
country: South Africa
facility: Louis Leipoldt Mediclinic
city: Benoni
country: South Africa
facility: Lakeview Hospital
city: Pretoria
country: South Africa
facility: 1007 Louis Pasteur Building
city: Pretoria
country: South Africa
facility: GCT Eastmed Clinical Trial centre
city: Western Cape
country: South Africa
facility: Constantiaberg Medi Clinic,
city: Wynberg
country: South Africa
facility: Prince Alfred House
city: Sagunto
country: Spain
facility: Hospital Sagunto
state: Valencia
city: Alcorcon - Madrid
country: Spain
facility: Fundación Hospital de Alcorcón, Otorhinolaryngology
city: Barcelona
country: Spain
facility: Hospital Clínico Barcelona, Dept. Of ORL
city: Madrid
country: Spain
facility: Hospital Puerta del Hierro, Madrid- Servicio de ORL
city: Madrid
country: Spain
facility: Hospital Universitario Príncipe de Asturias
city: Pamplona, Navarra
country: Spain
facility: Clínica Universitaria de Navarra, Dept. ORL
city: Salamanca
country: Spain
facility: Hospital Universitario de Salamanca- Hospital Virgen de la Vega
city: Bath
country: United Kingdom
facility: Oldfield Surgery
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Hospital
city: Chesterfield
country: United Kingdom
facility: Avondale Surgery, Research Office
city: Leicestershire
country: United Kingdom
facility: Burbage Surgery
city: Leicester
country: United Kingdom
facility: The university Hospitals of Leicester, Leicester Royal Infirmary
city: Newcastle upon Tyne
country: United Kingdom
facility: The Freeman Hospital
city: Petereborough
country: United Kingdom
facility: Wansford and Kings Cliffe Practice
city: Somerset
country: United Kingdom
facility: Frome Medical Practice
city: Warwickshire
country: United Kingdom
facility: Sherbourne Medical Centre
Study officials:
affiliation: Merz Pharmaceuticals
name: Medical Expert
role: STUDY_DIRECTOR
References: