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

Subjective Tinnitus Clinical Trial

— OLLTT  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00827008
• Other study ID #: MRZ 92579/TI/3004
• Secondary ID: 2008-001432-13
• Status: Terminated
• Phase: Phase 3
• First received: January 21, 2009
• Last updated: November 27, 2012
• Start date: January 2009
• Est. completion date: December 2011

Study information

• Verified date: November 2012
• Source: Merz Pharmaceuticals GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: EthikkommissionUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 821
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Subjective Tinnitus
• Tinnitus

Intervention

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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Merz Pharmaceuticals GmbH

Countries where clinical trial is conducted

United States,  Austria,  Belgium,  Brazil,  Czech Republic,  France,  Germany,  Mexico,  Netherlands,  Poland,  Portugal,  South Africa,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes