Efficacy, Safety and Tolerability of Neramexane in Comparison to Placebo in Patients With Subjective Tinnitus
- Registration Number
- NCT00772980
- Lead Sponsor
- Merz Pharmaceuticals GmbH
- Brief Summary
The purpose of this study is to investigate the safety and efficacy of neramexane mesylate in the treatment of subjective tinnitus in comparison to placebo.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 400
- patients aged 18 to 75 years with a clinical diagnosis of first onset, persistent (i.e. tinnitus sghould never be absent for >24 hours in a row), subjective, uni-or bilateral tinntius present for at least 3 months but not more than 12 months.
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Neramexane mesylate Drug: Neramexa mesylate Double-blind treatment period of 17 weeks up to 75 mg Neramexane mesylate per day 2 Placebo Drug: Placebo Double-blind treatment period of 17 weeks placebo
- Primary Outcome Measures
Name Time Method TBF-12 (Tinnitus-Beeinträchtigungs-Fragebogen-12 "Tinnitus Handycap Inventory-12") total score change from baseline to end of treatment Screening, Baseline, week 5, 13, 17
- Secondary Outcome Measures
Name Time Method TBF-12 factorial scores, individual respond rate, Tinnitus Rating Scale, Sleep Questionnaire, Qualitiy Of Life, population pharmacokinetics, optional pharmacogenetics 29 weeks safety parameters 29 weeks
Trial Locations
- Locations (54)
AZ Sint Lucas, ENT department
🇧🇪Gent, Belgium
University Hospital Brussels, ENT department
🇧🇪Brussels, Belgium
Clinique Universitaire Saint-Luc
🇧🇪Brussels, Belgium
Dr. Henri HABERMAN
🇧🇪Bruxelles, Belgium
Centre hospitalier de jolimont
🇧🇪La Louvière, Belgium
University Hospital Leuven, ENT Department
🇧🇪Leuven, Belgium
CHU Liege Service ORL
🇧🇪Liège, Belgium
Medico
🇨🇿Chodov, Prague, Czech Republic
Teaching University Hospital, ORL klinika
🇨🇿Brno, Czech Republic
BONFILS
🇫🇷Paris, France
ORL oddělení, Karlovarská krajská nemocncie a.s.
🇨🇿Karlovy Vary, Czech Republic
ORL oddělení, Všeobecná Fakultní Nemocnice v Praze
🇨🇿Praha, Czech Republic
OHRESSER
🇫🇷Paris, France
Andromed Breda
🇳🇱Breda, Netherlands
Hopital Paul BROUSSE Polyclinique
🇫🇷Villejuif, France
Andromed Oost
🇳🇱Velp, Netherlands
FRAYSSE
🇫🇷Toulouse cedex, France
Dr. J. Steer
🇿🇦Wynberg, South Africa
Service ORL CHU
🇫🇷Tours, France
Dr. Ebbo
🇫🇷Issy les moulineaux, France
Dr. Sarfati
🇫🇷La seyne sur Mer, France
Hopital Edouard Herriot
🇫🇷Lyon cedex 03, France
Pro-audio,s.r.o.-private ENT clinic
🇨🇿Mladá Boleslav, Czech Republic
Prof. MUDr. Ivo Šlapák, CSc
🇨🇿Brno, Czech Republic
Nemocnice Havlíčkův Brod
🇨🇿Havlíčkův Brod, Czech Republic
Hopital Nord
🇫🇷Saint-Etienne, France
Rijnland Ziekenhuis, ENT department
🇳🇱Leiderdorp, Netherlands
Centre Hospitalier de Bretagne Sud Service
🇫🇷Lorient, France
Adromed Nijmegen
🇳🇱Nijmegen, Netherlands
Andromed Rotterdam
🇳🇱Rotterdam, Netherlands
Niepubliczny Zaklad Opieki Zdrowotnej Prywatne Centrum Medyczne PROMEDIS
🇵🇱Gdansk, Poland
Samodzielny Publiczny Szpital Kliniczny im. Andrzeja Mieleckiego Slaskiego Uniwersytetu Medycznego w Katowicach
🇵🇱Katowice, Poland
NZOZ Specjalistyczne Centrum Medyczne Nowomed
🇵🇱Krakow, Poland
Uniwersytecki Szpital Kliniczny w Bialymstoku
🇵🇱Bialystok, Poland
Szpital Miejski im. J.Brudzinskiego
🇵🇱Gdynia, Poland
Specjalistyczny Gabinet Otolaryngologiczny Dr Anna Otto- Markiewicz
🇵🇱Krakow, Poland
Niepubliczny Zaklad Opieki Zdrowotnej PROMED
🇵🇱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 w Olsztynie
🇵🇱Olsztyn, Poland
Instytut Medycyny Pracy im. Prof. Dr med. Jerzego Nofera w Lodzi
🇵🇱Lodz, Poland
Constantiaberg Medi Clinic
🇿🇦Western Cape, South Africa
Instytut Fizjologii i Patologii Sluchu
🇵🇱Warszawa, Poland
Louis Leipoldt Mediclinic
🇿🇦Bellville, South Africa
Lakeview Hospital
🇿🇦Benoni, South Africa
Wojewodzki Szpital Specjalistyczny im. Stefana Kardynała Wyszynskiego Samodzielny Publiczny Zaklad Opieki Zdrowotnej
🇵🇱Lublin, Poland
GCT Eastmed Clinical Trial centre
🇿🇦Pretoria, South Africa
Dr. A. Viljoen
🇿🇦Pretoria, South Africa
Andromed Leiden
🇳🇱Leiderdorp, Netherlands
Oblastní nemocnice Kladno a.s.
🇨🇿Kladno, Czech Republic
Samodzielny Publiczny Szpital Kliniczny nr 1 we Wroclawiu
🇵🇱Wroclaw, Poland
ORL - Otorynolaryngologické oddělení
🇨🇿Jihlava, Czech Republic
ORL oddělení , Karlovarská krajská nemocnice a. s.
🇨🇿Sokolov, Czech Republic
Andromed Zoetermeer
🇳🇱Zoetermeer, Netherlands