Subjective TinnitusPhase 3OLLTTNCT00827008
Open-Label, Long-Term Treatment Study, to Assess the Long-Term Safety and Tolerability and Efficacy of Neramexane in Patients With Subjective Tinnitus
A Phase 3 study testing Neramexane mesylate in people with Subjective Tinnitus, run by Merz Pharmaceuticals GmbH at 135 sites in 14 countries.
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 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Subjective Tinnitus
- What is being tested?
- Neramexane mesylate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 821 participants
- Where
- 135 sitesin 14 countries
- Study dates
- Jan 2009to Dec 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.)
Trial locations and contacts
135 sites in 14 countries.
135 sites in 14 countries
United States31 sites
Future Search Trials of Neurology
Austin, Texas, 78756
Immedicenter
Bloomfield, New Jersey, 07003
Visions Clinical Research
Boynton Beach, Florida, 33472
Erie County Medical Center, Department of Rehabilitation Medicine
Buffalo, New York, 14221
Providence Clinical Research
Burbank, California, 91505
Cary Medical Research
Cary, North Carolina, 27518
Medical University of South Carolina - Department of Otolaryngology, Department of Otolaryngology - Head & Neck Surgery
Charleston, South Carolina, 29425-5500
Colorado Otolaryngology Associates
Colorado Springs, Colorado, 80909
FutureSearch Trials of Dallas
Dallas, Texas, 75231
Central California Clinical Research
Fresno, California, 93720
New West Physicians
Golden, Colorado, 80401
Deerpath Physicians Group
Gurnee, Illinois, 60031
Glacier Ear, Nose, and Throat, Head and Neck Surgery, P.C.
Kalispell, Montana, 59901
University of Kansas Department of Otolaryngology Head & Neck Surgery
Kansas City, Kansas, 66160-0001
R/D Clinical Research, Inc.
Lake Jackson, Texas, 77566
South Texas Research Alliance LLC
Laredo, Texas, 78041
Commonwealth Ear, Nose & Throat
Louisville, Kentucky, 40207
Health Research of Hampton Roads, Inc.
Newport News, Virginia, 23606
Knight Center for Integrated Health,
Peoria, Illinois, 61614
Research Across America
Plano, Texas, 75093
Wake Research Associates, LLC
Raleigh, North Carolina, 27612
UC Davis Health System Department of Otolaryngology
Sacramento, California, 95817
David L. Bortniker, M.D, FACS
Somerville, New Jersey, 08876
Clinical Research of West Florida
Tampa, Florida, 33603
Montefiore Medical Center Attn: Anxiety and Depression Center
The Bronx, New York, 10867
Paradigm Clinical Research
Tucson, Arizona, 85705
Advanced Clinical Research
West Jordon, Utah, 84088
Heartland Research Associates, LLC.
Wichita, Kansas, 67205
Heartland Research Associates, LLC.
Wichita, Kansas, 67207
Wilmington Medical Research
Wilmington, North Carolina, 28401
Piedmont Medical Research
Winston-Salem, North Carolina, 27103
Germany21 sites
Dr. med. Norbert Pasch
Aachen, 52074
Charité, Universitätsmedizin Berlin-Tinnituszentrum
Berlin, 10117
Klin. Forschung Berlin Buch GmbH
Berlin, 13125
Dr. med. Frank Reintjes
Braunschweig, 38100
DM Helena Sigal
Chemnitz, 09120
Dr. Klaus Peter Jayme
Darmstadt, 64283
Dr. Christian Dörr
Dresden, 01277
HNO-Praxis im Gesundheitszentrum
Duisburg, 47179
Dr. Kühne, Elisabeth
Halle, Saale, 06112
Dr. Gieselmann, Werner
Heiligenhaus, 42579
Dr. Wolfgang Lotte
Iserlohn, 58642
Dr. Dr. med. Hans-Detlev Stahl
Leipzig, 04103
HNO Praxis
Lichtenfels, 96215
Dr. Dannesberger
Lorsch, 64653
ClinPharm International
Magdeburg, 39104
HNO Gemeinschaftpraxis
Meppen, 48716
Martin Canis, MD
Munich, 81377
Dr. med. Ulrike Walter
Nuremberg, 90402
Dr. Susanne Wiedemann
Nuremberg, 90443
Dr. Norbert Staab
Schlüchtern, 36381
Dr. Hannelore Neumaier
Wiesbaden, 65183
Poland13 sites
Uniwersytecki Szpital Kliniczny w Bialymstoku
Bialystok, 15-276
Niepubliczny Zaklad Opieki Zdrowotnej Prywatne Centrum Medyczne PROMEDIS
Gdansk, 80-288
Szpital Miejski im. J.Brudzinskiego
Gdynia, 81-348
Samodzielny Publiczny Szpital Kliniczny im. Andrzeja Mieleckiego Slaskiego Uniwersytetu Medycznego w Katowicach
Katowice, 40-027
NZOZ Specjalistyczne Centrum Medyczne Nowomed
Krakow, 30-349
Niepubliczny Zaklad Opieki Zdrowotnej PROMED
Krakow, 31- 636
Specjalistyczny Gabinet Otolaryngologiczny
Krakow, 31-534
Szpital Specjalistyczny im. Stefana Zeromskiego, SP ZOZ w Krakowie, Oddzial Otolaryngologii
Krakow, 31-913
Samodzielny Publiczny Zaklad Opieki Zdrowotnej, Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi
Lodz, 91-153
Wojewodzki Szpital Specjalistyczny im. Stefana Kardynała Wyszynskiego Samodzielny Publiczny Zaklad Opieki Zdrowotnej
Lublin, 20-718
Wojewodzki Szpital Specjalistyczny w Olsztynie
Olsztyn, 10-561
Instytut Fizjologii i Patologii Sluchu
Warsaw, 01-943
Samodzielny Publiczny Szpital Kliniczny nr 1 we Wroclawiu
Wroclaw, 50-369
Mexico12 sites
Unidad Médica de Especialidades del Noroeste (UMEN)
Centro Culiacán Sinaloa, 80000
Hospital General de Chihuahua. "Dr. Salvador Anchondo"
Chihuahua C.P. 31000
Hospital Christus Muguerza del Parque
Chihuahua CP 3100
Internal Medicine Clin Trials (IMED)
Col Obispado, Monterrey , N.L. C.P. 64060
Hospital Civil de Guadalajara
Col. El Retiro CP 44280 Cuadalajara Jalis
Grupo Médico Terranova
CP 44630 Guadalajara Jalisco
Clinical Research Instutute S.C.
Edo. de México CP 54055
Instituto Biomédico de Investigación A.C.
Fracc. Bosques Del Prado Norte Aguascalientes, CP 20127
Unidad de Investigación Clínica Cardiometábolica de Occidente S.C. (UNICAMO)
Jalisco
Monterrey International Research Center (MIRC)
Nuevo León CP 64000
Hospital Universitario Dr. José Eleuterio González. Edificio Elizondo Barragán, Servicio de Otorrinolaringología
Nuevo León CP 64400
Hospital Central "Dr. Ignacio Morones Prieto" Servicio de Otorrinolaringología
San Luis Potosí, SLP, México, 78240
France9 sites
Dr. Ebbo
Issy-les-Moulineaux, 92130
Dr. Sarfati
La Seyne-sur-Mer, 83500
Centre Hospitalier de Bretagne Sud Service ORL-B9
Lorient, 2233-56322
Dr. Bonfils
Paris, 75015
Dr. Ohresser
Paris, 75015
Hopital Nord
Saint-Etienne, 42055
Dr. Fraysse
Toulouse, 31059
Service ORL CHU Bretonneau
Tours, 37044
Hopital Paul BROUSSE Polyclinique
Villejuif, 94800
United Kingdom9 sites
Oldfield Surgery
Bath, BA2 3HT
Addenbrooke's Hospital
Cambridge, CB2 2QQ
Avondale Surgery, Research Office
Chesterfield, S40 4TF
The university Hospitals of Leicester, Leicester Royal Infirmary
Leicester, LE1 5WW
Burbage Surgery
Leicestershire, LE10 2SE
The Freeman Hospital
Newcastle upon Tyne, NE7 7DN
Wansford and Kings Cliffe Practice
Petereborough, PE8 6PL
Frome Medical Practice
Somerset, BA11 1EZ
Sherbourne Medical Centre
Warwickshire, CV32 4RA
Czechia8 sites
prof. MUDr. Ivo Šlapák
Brno, 602 00
Teaching University Hospital, ORL klinika
Brno, 65691
Medico
Chodov, Prague, 4
ORL oddělení, Karlovarská krajská nemocncie a.s.
Karlovy Vary, 360 66
Oblastní nemocnice Kladno a.s., Nemocnice Středočeského kraje
Kladno, 272 59
Pro-audio,s.r.o.-private ENT clinic
Mladá Boleslav, 29301
ORL oddělení, Všeobecná Fakultní Nemocnice v Praze
Prague, 128 08
ORL oddělení , Karlovarská krajská nemocnice a. s.
Sokolov, 356 01
Netherlands7 sites
Andromed Breda
Breda, VL, 4811
Rijnland Ziekenhuis, ENT department
Leiderdorp, GA, 2353
Andromed Leiden
Leiderdorp, RA, 2352
Adromed Nijmegen
Nijmegen, HL, 6533
Andromed Rotterdam
Rotterdam, HC, 3021
Andromed Oost
Velp, ES, 6883
Andromed Zoetermeer
Zoetermeer, EK, 2724
Spain7 sites
Fundación Hospital de Alcorcón, Otorhinolaryngology
Alcorcon - Madrid, 28922
Hospital Clínico Barcelona, Dept. Of ORL
Barcelona, 08036
Hospital Puerta del Hierro, Madrid- Servicio de ORL
Madrid, 28035
Hospital Universitario Príncipe de Asturias
Madrid, 28805
Clínica Universitaria de Navarra, Dept. ORL
Pamplona, Navarra, 31008
Hospital Sagunto
Sagunto, Valencia, 46520
Hospital Universitario de Salamanca- Hospital Virgen de la Vega
Salamanca, 37007
South Africa6 sites
Louis Leipoldt Mediclinic
Bellville, 7530
Lakeview Hospital
Benoni, 1501
1007 Louis Pasteur Building
Pretoria, 0002
GCT Eastmed Clinical Trial centre
Pretoria, 0186
Constantiaberg Medi Clinic,
Western Cape, 7800
Prince Alfred House
Wynberg, 7800
Belgium4 sites
University Hospital Brussels
Brussels, 1090
Clinique Universitaire Saint-luc
Brussels, 1200
AZ Sint Lucas, ENT department
Ghent, 9000
University Hospital Leuven, ENT Department
Leuven, 3000
Brazil4 sites
Consultório Dr. Marcelo Rates
Belo Horizonte/Mimaf Gerais, CEP 30150-270
Osmar Clayton Person
Santo André/SP, zip 09060-650
Instituto Ganz Sanchez
São Paulo/SP, ZIP CODE: 05469-000
Clínica OTOSUL
Valenca/RJ, CEP.: 27211-130
Austria3 sites
Krankenhaus der Elisabethinen
Graz, 8020
Bezirkskrankenhaus Kufstein Dr. Christof Pauli (PI: Prim. Dr. Peter Ostertag
Kufstein, 6330
Clin Pharm International GmbH, Zentrum Wien
Vienna, 1090
Portugal1 site
Hospital Militar Regional nº 1 Serviço de Otorrinolaringologia
Porto, 4050-113
About this study
Official title: An Open-Label, Long-Term Treatment Study to Assess the Long-Term Safety and Tolerability and Efficacy of Neramexane With Subjective Tinnitus
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
- Conditions
- Subjective Tinnitus
- Being tested
- Neramexane mesylate
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neramexane mesylateDrug
Up-titration treatment period of 5 weeks up to 75mg Neramexane mesylate oral per day followed by 49 weeks treatment maintenance
| Study group | Role | What they receive |
|---|---|---|
| 1, verum | Experimental | Not described Receives: Drug: Neramexane mesylate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 54 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subjective TinnitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 821 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merz Pharmaceuticals GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Expert, Study director, Merz Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00827008
- Sponsor's protocol ID
- MRZ 92579/TI/3004
- Other IDs
- 2008-001432-13, 2008
- Acronym
- OLLTT
- Status last verified
- Nov 2012
- First submitted
- 21 Jan 2009
- Last updated
- 28 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Long-Term Treatment Study to Assess the Long-Term Safety and Tolerability and Efficacy of Neramexane With Subjective Tinnitus
- ClinicalTrials.gov ID
- NCT00827008
- Acronym / sponsor ID
- OLLTT / MRZ 92579/TI/3004
- Conditions
- Subjective Tinnitus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 821 participants (actual)
- Lead sponsor
- Merz Pharmaceuticals GmbHIndustry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 22 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1, verum | Experimental | Drug: Neramexane mesylate |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neramexane mesylateUp-titration treatment period of 5 weeks up to 75mg Neramexane mesylate oral per day followed by 49 weeks treatment maintenance | Drug | 1, verum |
Primary outcome
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
Time frame: 54 weeks
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2012.
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Efficacy Analysis of Transcutaneous Auricular Vagus Nerve Stimulation Combined With Tailor-Made Notched Music Therapy in the Treatment of Chronic Subjective Tinnitus
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COMPARISON OF MANUAL THERAPY, TINNITUS RETRAINING THERAPY
Somatosensory Tinnitus, Subjektif tınnitus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Expert study director
Merz Pharmaceuticals
135 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Neramexane mesylate in people with Subjective Tinnitus, run by Merz Pharmaceuticals GmbH at 135 sites in 14 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 135 sites in United States, Germany, Poland, Mexico, France and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: 54 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2012.