OLLTT: Open-Label, Long-Term Treatment Study, to Assess the Long-Term Safety and Tolerability and Efficacy of Neramexane in Patients With Subjective Tinnitus
Sponsor
Merz Pharmaceuticals GmbH (Industry)
Overall Status
Terminated
CT.gov ID
NCT00827008
Collaborator
(none)
821
135
1
35
6.1
0.2
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
821 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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 Start Date
:
Jan 1, 2009
Actual Primary Completion Date
:
Dec 1, 2011
Actual Study Completion Date
:
Dec 1, 2011
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 1, verum
|
Drug: Neramexane mesylate
Up-titration treatment period of 5 weeks up to 75mg Neramexane mesylate oral per day followed by 49 weeks treatment maintenance
|
Outcome Measures
Primary Outcome Measures
- 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]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Paradigm Clinical Research | Tucson | Arizona | United States | 85705 |
| 2 | Providence Clinical Research | Burbank | California | United States | 91505 |
| 3 | Central California Clinical Research | Fresno | California | United States | 93720 |
| 4 | UC Davis Health System Department of Otolaryngology | Sacramento | California | United States | 95817 |
| 5 | Colorado Otolaryngology Associates | Colorado Springs | Colorado | United States | 80909 |
| 6 | New West Physicians | Golden | Colorado | United States | 80401 |
| 7 | Visions Clinical Research | Boynton Beach | Florida | United States | 33472 |
| 8 | Clinical Research of West Florida | Tampa | Florida | United States | 33603 |
| 9 | Deerpath Physicians Group | Gurnee | Illinois | United States | 60031 |
| 10 | Knight Center for Integrated Health, | Peoria | Illinois | United States | 61614 |
| 11 | University of Kansas Department of Otolaryngology Head & Neck Surgery | Kansas City | Kansas | United States | 66160-0001 |
| 12 | Heartland Research Associates, LLC. | Wichita | Kansas | United States | 67205 |
| 13 | Heartland Research Associates, LLC. | Wichita | Kansas | United States | 67207 |
| 14 | Commonwealth Ear, Nose & Throat | Louisville | Kentucky | United States | 40207 |
| 15 | Glacier Ear, Nose, and Throat, Head and Neck Surgery, P.C. | Kalispell | Montana | United States | 59901 |
| 16 | Immedicenter | Bloomfield | New Jersey | United States | 07003 |
| 17 | David L. Bortniker, M.D, FACS | Somerville | New Jersey | United States | 08876 |
| 18 | Montefiore Medical Center Attn: Anxiety and Depression Center | Bronx | New York | United States | 10867 |
| 19 | Erie County Medical Center, Department of Rehabilitation Medicine | Buffalo | New York | United States | 14221 |
| 20 | Cary Medical Research | Cary | North Carolina | United States | 27518 |
| 21 | Wake Research Associates, LLC | Raleigh | North Carolina | United States | 27612 |
| 22 | Wilmington Medical Research | Wilmington | North Carolina | United States | 28401 |
| 23 | Piedmont Medical Research | Winston-Salem | North Carolina | United States | 27103 |
| 24 | Medical University of South Carolina - Department of Otolaryngology, Department of Otolaryngology - Head & Neck Surgery | Charleston | South Carolina | United States | 29425-5500 |
| 25 | Future Search Trials of Neurology | Austin | Texas | United States | 78756 |
| 26 | FutureSearch Trials of Dallas | Dallas | Texas | United States | 75231 |
| 27 | R/D Clinical Research, Inc. | Lake Jackson | Texas | United States | 77566 |
| 28 | South Texas Research Alliance LLC | Laredo | Texas | United States | 78041 |
| 29 | Research Across America | Plano | Texas | United States | 75093 |
| 30 | Advanced Clinical Research | West Jordon | Utah | United States | 84088 |
| 31 | Health Research of Hampton Roads, Inc. | Newport News | Virginia | United States | 23606 |
| 32 | Krankenhaus der Elisabethinen | Graz | Austria | 8020 | |
| 33 | Bezirkskrankenhaus Kufstein Dr. Christof Pauli (PI: Prim. Dr. Peter Ostertag | Kufstein | Austria | 6330 | |
| 34 | Clin Pharm International GmbH, Zentrum Wien | Vienna | Austria | 1090 | |
| 35 | University Hospital Brussels | Brussels | Belgium | 1090 | |
| 36 | Clinique Universitaire Saint-luc | Bruxelles | Belgium | 1200 | |
| 37 | AZ Sint Lucas, ENT department | Gent | Belgium | 9000 | |
| 38 | University Hospital Leuven, ENT Department | Leuven | Belgium | 3000 | |
| 39 | Consultório Dr. Marcelo Rates | Belo Horizonte/Mimaf Gerais | Brazil | CEP 30150-270 | |
| 40 | Osmar Clayton Person | Santo André/SP | Brazil | zip 09060-650 | |
| 41 | Instituto Ganz Sanchez | São Paulo/SP | Brazil | ZIP CODE: 05469-000 | |
| 42 | Clínica OTOSUL | Valenca/RJ | Brazil | CEP.: 27211-130 | |
| 43 | Medico | Chodov | Prague | Czech Republic | 4 |
| 44 | prof. MUDr. Ivo Šlapák | Brno | Czech Republic | 602 00 | |
| 45 | Teaching University Hospital, ORL klinika | Brno | Czech Republic | 65691 | |
| 46 | ORL oddělení, Karlovarská krajská nemocncie a.s. | Karlovy Vary | Czech Republic | 360 66 | |
| 47 | Oblastní nemocnice Kladno a.s., Nemocnice Středočeského kraje | Kladno | Czech Republic | 272 59 | |
| 48 | Pro-audio,s.r.o.-private ENT clinic | Mladá Boleslav | Czech Republic | 29301 | |
| 49 | ORL oddělení, Všeobecná Fakultní Nemocnice v Praze | Praha | Czech Republic | 128 08 | |
| 50 | ORL oddělení , Karlovarská krajská nemocnice a. s. | Sokolov | Czech Republic | 356 01 | |
| 51 | Dr. Ebbo | Issy les moulineaux | France | 92130 | |
| 52 | Dr. Sarfati | La seyne sur Mer | France | 83500 | |
| 53 | Centre Hospitalier de Bretagne Sud Service ORL-B9 | Lorient | France | 2233-56322 | |
| 54 | Dr. Bonfils | Paris | France | 75015 | |
| 55 | Dr. Ohresser | Paris | France | 75015 | |
| 56 | Hopital Nord | Saint-etienne | France | 42055 | |
| 57 | Dr. Fraysse | Toulouse cedex | France | 31059 | |
| 58 | Service ORL CHU Bretonneau | Tours | France | 37044 | |
| 59 | Hopital Paul BROUSSE Polyclinique | Villejuif | France | 94800 | |
| 60 | Dr. Kühne, Elisabeth | Halle | Saale | Germany | 06112 |
| 61 | Dr. med. Norbert Pasch | Aachen | Germany | 52074 | |
| 62 | Charité, Universitätsmedizin Berlin-Tinnituszentrum | Berlin | Germany | 10117 | |
| 63 | Klin. Forschung Berlin Buch GmbH | Berlin | Germany | 13125 | |
| 64 | Dr. med. Frank Reintjes | Braunschweig | Germany | 38100 | |
| 65 | DM Helena Sigal | Chemnitz | Germany | 09120 | |
| 66 | Dr. Klaus Peter Jayme | Darmstadt | Germany | 64283 | |
| 67 | Dr. Christian Dörr | Dresden | Germany | 01277 | |
| 68 | HNO-Praxis im Gesundheitszentrum | Duisburg | Germany | 47179 | |
| 69 | Dr. Gieselmann, Werner | Heiligenhaus | Germany | 42579 | |
| 70 | Dr. Wolfgang Lotte | Iserlohn | Germany | 58642 | |
| 71 | Dr. Dr. med. Hans-Detlev Stahl | Leipzig | Germany | 04103 | |
| 72 | HNO Praxis | Lichtenfels | Germany | 96215 | |
| 73 | Dr. Dannesberger | Lorsch | Germany | 64653 | |
| 74 | ClinPharm International | Magdeburg | Germany | 39104 | |
| 75 | HNO Gemeinschaftpraxis | Meppen | Germany | 48716 | |
| 76 | Martin Canis, MD | Munich | Germany | 81377 | |
| 77 | Dr. Susanne Wiedemann | Nuernberg | Germany | 90443 | |
| 78 | Dr. med. Ulrike Walter | Nürnberg | Germany | 90402 | |
| 79 | Dr. Norbert Staab | Schlüchtern | Germany | 36381 | |
| 80 | Dr. Hannelore Neumaier | Wiesbaden | Germany | 65183 | |
| 81 | Unidad Médica de Especialidades del Noroeste (UMEN) | Centro Culiacán Sinaloa | Mexico | 80000 | |
| 82 | Hospital General de Chihuahua. "Dr. Salvador Anchondo" | Chihuahua C.P. 31000 | Mexico | ||
| 83 | Hospital Christus Muguerza del Parque | Chihuahua CP 3100 | Mexico | ||
| 84 | Internal Medicine Clin Trials (IMED) | Col Obispado, Monterrey , N.L. C.P. 64060 | Mexico | ||
| 85 | Hospital Civil de Guadalajara | Col. El Retiro CP 44280 Cuadalajara Jalis | Mexico | ||
| 86 | Grupo Médico Terranova | CP 44630 Guadalajara Jalisco | Mexico | ||
| 87 | Clinical Research Instutute S.C. | Edo. de México CP 54055 | Mexico | ||
| 88 | Instituto Biomédico de Investigación A.C. | Fracc. Bosques del Prado Norte Aguascalientes | Mexico | CP 20127 | |
| 89 | Unidad de Investigación Clínica Cardiometábolica de Occidente S.C. (UNICAMO) | Jalisco, 44150 | Mexico | ||
| 90 | Monterrey International Research Center (MIRC) | Nuevo León CP 64000 | Mexico | ||
| 91 | Hospital Universitario Dr. José Eleuterio González. Edificio Elizondo Barragán, Servicio de Otorrinolaringología | Nuevo León CP 64400 | Mexico | ||
| 92 | Hospital Central "Dr. Ignacio Morones Prieto" Servicio de Otorrinolaringología | San Luis Potosí, SLP, México, 78240 | Mexico | ||
| 93 | Andromed Zoetermeer | Zoetermeer | EK | Netherlands | 2724 |
| 94 | Andromed Oost | Velp | ES | Netherlands | 6883 |
| 95 | Rijnland Ziekenhuis, ENT department | Leiderdorp | GA | Netherlands | 2353 |
| 96 | Andromed Rotterdam | Rotterdam | HC | Netherlands | 3021 |
| 97 | Adromed Nijmegen | Nijmegen | HL | Netherlands | 6533 |
| 98 | Andromed Leiden | Leiderdorp | RA | Netherlands | 2352 |
| 99 | Andromed Breda | Breda | VL | Netherlands | 4811 |
| 100 | Uniwersytecki Szpital Kliniczny w Bialymstoku | Bialystok | Poland | 15-276 | |
| 101 | Niepubliczny Zaklad Opieki Zdrowotnej Prywatne Centrum Medyczne PROMEDIS | Gdansk | Poland | 80-288 | |
| 102 | Szpital Miejski im. J.Brudzinskiego | Gdynia | Poland | 81-348 | |
| 103 | Samodzielny Publiczny Szpital Kliniczny im. Andrzeja Mieleckiego Slaskiego Uniwersytetu Medycznego w Katowicach | Katowice | Poland | 40-027 | |
| 104 | NZOZ Specjalistyczne Centrum Medyczne Nowomed | Krakow | Poland | 30-349 | |
| 105 | Niepubliczny Zaklad Opieki Zdrowotnej PROMED | Krakow | Poland | 31- 636 | |
| 106 | Specjalistyczny Gabinet Otolaryngologiczny | Krakow | Poland | 31-534 | |
| 107 | Szpital Specjalistyczny im. Stefana Zeromskiego, SP ZOZ w Krakowie, Oddzial Otolaryngologii | Krakow | Poland | 31-913 | |
| 108 | Samodzielny Publiczny Zaklad Opieki Zdrowotnej, Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi | Lodz | Poland | 91-153 | |
| 109 | Wojewodzki Szpital Specjalistyczny im. Stefana Kardynała Wyszynskiego Samodzielny Publiczny Zaklad Opieki Zdrowotnej | Lublin | Poland | 20-718 | |
| 110 | Wojewodzki Szpital Specjalistyczny w Olsztynie | Olsztyn | Poland | 10-561 | |
| 111 | Instytut Fizjologii i Patologii Sluchu | Warszawa | Poland | 01-943 | |
| 112 | Samodzielny Publiczny Szpital Kliniczny nr 1 we Wroclawiu | Wroclaw | Poland | 50-369 | |
| 113 | Hospital Militar Regional nº 1 Serviço de Otorrinolaringologia | Porto | Portugal | 4050-113 | |
| 114 | Louis Leipoldt Mediclinic | Bellville | South Africa | 7530 | |
| 115 | Lakeview Hospital | Benoni | South Africa | 1501 | |
| 116 | 1007 Louis Pasteur Building | Pretoria | South Africa | 0002 | |
| 117 | GCT Eastmed Clinical Trial centre | Pretoria | South Africa | 0186 | |
| 118 | Constantiaberg Medi Clinic, | Western Cape | South Africa | 7800 | |
| 119 | Prince Alfred House | Wynberg | South Africa | 7800 | |
| 120 | Hospital Sagunto | Sagunto | Valencia | Spain | 46520 |
| 121 | Fundación Hospital de Alcorcón, Otorhinolaryngology | Alcorcon - Madrid | Spain | 28922 | |
| 122 | Hospital Clínico Barcelona, Dept. Of ORL | Barcelona | Spain | 08036 | |
| 123 | Hospital Puerta del Hierro, Madrid- Servicio de ORL | Madrid | Spain | 28035 | |
| 124 | Hospital Universitario Príncipe de Asturias | Madrid | Spain | 28805 | |
| 125 | Clínica Universitaria de Navarra, Dept. ORL | Pamplona, Navarra | Spain | 31008 | |
| 126 | Hospital Universitario de Salamanca- Hospital Virgen de la Vega | Salamanca | Spain | 37007 | |
| 127 | Oldfield Surgery | Bath | United Kingdom | BA2 3HT | |
| 128 | Addenbrooke's Hospital | Cambridge | United Kingdom | CB2 2QQ | |
| 129 | Avondale Surgery, Research Office | Chesterfield | United Kingdom | S40 4TF | |
| 130 | Burbage Surgery | Leicestershire | United Kingdom | LE10 2SE | |
| 131 | The university Hospitals of Leicester, Leicester Royal Infirmary | Leicester | United Kingdom | LE1 5WW | |
| 132 | The Freeman Hospital | Newcastle upon Tyne | United Kingdom | NE7 7DN | |
| 133 | Wansford and Kings Cliffe Practice | Petereborough | United Kingdom | PE8 6PL | |
| 134 | Frome Medical Practice | Somerset | United Kingdom | BA11 1EZ | |
| 135 | Sherbourne Medical Centre | Warwickshire | United Kingdom | CV32 4RA |
Sponsors and Collaborators
- Merz Pharmaceuticals GmbH
Investigators
- Study Director: Medical Expert, Merz Pharmaceuticals
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Merz Pharmaceuticals GmbH
ClinicalTrials.gov Identifier:
NCT00827008
Other Study ID Numbers:
- MRZ 92579/TI/3004
- 2008-001432-13
First Posted:
Jan 22, 2009
Last Update Posted:
Nov 28, 2012
Last Verified:
Nov 1, 2012
Additional relevant MeSH terms: