Subjective TinnitusPhase 3NCT00772980
Efficacy, Safety and Tolerability of Neramexane in Comparison to Placebo in Patients With Subjective Tinnitus
A Phase 3 study testing Neramexane mesylate in people with Subjective Tinnitus, run by Merz Pharmaceuticals GmbH at 56 sites in 6 countries.
Trial 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. 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
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 56 sitesin 6 countries
- Study dates
- Nov 2008to Jun 2010
- 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
Who may be able to join
- 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.
Who cannot join
- 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
56 sites in 6 countries.
56 sites in 6 countries
Poland14 sites
Uniwersytecki Szpital Kliniczny w Bialymstoku
Bialystok, 15-279
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
Specjalistyczny Gabinet Otolaryngologiczny Dr Anna Otto- Markiewicz
Krakow, 31-534
Niepubliczny Zaklad Opieki Zdrowotnej PROMED
Krakow, 31-636
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
Instytut Medycyny Pracy im. Prof. Dr med. Jerzego Nofera w Lodzi
Lodz, 91-348
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
Czechia10 sites
Prof. MUDr. Ivo Šlapák, CSc
Brno, 60200
Teaching University Hospital, ORL klinika
Brno, 65691
Medico
Chodov, Prague
Nemocnice Havlíčkův Brod
Havlíčkův Brod, 58022
ORL - Otorynolaryngologické oddělení
Jihlava, 58633
ORL oddělení, Karlovarská krajská nemocncie a.s.
Karlovy Vary, 36066
Oblastní nemocnice Kladno a.s.
Kladno, 27259
Pro-audio,s.r.o.-private ENT clinic
Mladá Boleslav, 29301
ORL oddělení, Všeobecná Fakultní Nemocnice v Praze
Prague, 12808
ORL oddělení , Karlovarská krajská nemocnice a. s.
Sokolov, 35601
France10 sites
Dr. Ebbo
Issy-les-Moulineaux, 92130
Dr. Sarfati
La Seyne-sur-Mer, 83500
Centre Hospitalier de Bretagne Sud Service
Lorient, 56322
Hopital Edouard Herriot
Lyon, 69437
BONFILS
Paris, 75015
OHRESSER
Paris, 75015
Hopital Nord
Saint-Etienne, 42055
FRAYSSE
Toulouse, 31059
Service ORL CHU
Tours, 37044
Hopital Paul BROUSSE Polyclinique
Villejuif, 94800
Belgium8 sites
AZ Sint Lucas, ENT department
Assebroek-Brugge, 8310
University Hospital Brussels, ENT department
Brussels, 1090
Clinique Universitaire Saint-Luc
Brussels, 1200
Dr. Henri HABERMAN
Brussels, 1200
AZ Sint Lucas, ENT department
Ghent, 9000
Centre hospitalier de jolimont
La Louvière, 7100
University Hospital Leuven, ENT Department
Leuven, 3000
CHU Liege Service ORL
Liège, 4000
Netherlands8 sites
Andromed Breda
Breda, 4811 VL
Andromed Leiden
Leiderdorp, 2352 RA
Rijnland Ziekenhuis, ENT department
Leiderdorp, 2353 GA
Adromed Nijmegen
Nijmegen, 6533 HL
Andromed Rotterdam
Rotterdam, 3021 HC
Andromed Rotterdam
Rotterdam, HC 3021
Andromed Oost
Velp, 6883 ES
Andromed Zoetermeer
Zoetermeer, 2724 EK
South Africa6 sites
Louis Leipoldt Mediclinic
Bellville, 7530
Lakeview Hospital
Benoni, 1501
Dr. A. Viljoen
Pretoria, 0002
GCT Eastmed Clinical Trial centre
Pretoria, 0186
Constantiaberg Medi Clinic
Western Cape, 7800
Dr. J. Steer
Wynberg, 7800
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Clinical Evaluation of the Efficacy, Safety and Tolerability of Neramexane in Patients With Subjective Tinnitus
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.
- Conditions
- Subjective Tinnitus
- Being tested
- Neramexane mesylate, Placebo
- 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
Double-blind treatment period of 17 weeks up to 75 mg Neramexane mesylate per day, 12 weeks follow-up.
PlaceboDrug
Double-blind treatment period of 17 weeks placebo, 12 weeks follow-up.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Drug: Neramexa mesylate Double-blind treatment period of 17 weeks up to 75 mg Neramexane mesylate per day Receives: Drug: Neramexane mesylate |
| 2 | Placebo comparator | Drug: Placebo Double-blind treatment period of 17 weeks placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
TBF-12 (Tinnitus-Beeinträchtigungs-Fragebogen-12 "Tinnitus Handycap Inventory-12") total score change from baseline to end of treatment
Measured: Screening, Baseline, week 5, 13, 17
Secondary outcomes (2)
TBF-12 factorial scores, individual respond rate, Tinnitus Rating Scale, Sleep Questionnaire, Qualitiy Of Life, population pharmacokinetics, optional pharmacogenetics
Measured: 29 weeks
safety parameters
Measured: 29 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2008 (estimated)
- Study startNov 2008
- Primary completionJun 2010
- Study completionJun 2010
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Merz Pharmaceuticals GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00772980
- Sponsor's protocol ID
- MRZ 92579/TI/3002
- Other IDs
- EudraCT Number 2008-000639-16
- Status last verified
- Jun 2010
- First submitted
- 13 Oct 2008
- Last updated
- 1 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Clinical Evaluation of the Efficacy, Safety and Tolerability of Neramexane in Patients With Subjective Tinnitus
- ClinicalTrials.gov ID
- NCT00772980
- Acronym / sponsor ID
- MRZ 92579/TI/3002
- Conditions
- Subjective Tinnitus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Merz Pharmaceuticals GmbHIndustry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 15 Oct 2008 (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 safety and efficacy of neramexane mesylate in the treatment of subjective tinnitus in comparison to placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Neramexane mesylateDrug: Neramexa mesylate Double-blind treatment period of 17 weeks up to 75 mg Neramexane mesylate per day |
| 2 | Placebo comparator | Drug: PlaceboDrug: Placebo Double-blind treatment period of 17 weeks placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.)
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 mesylateDouble-blind treatment period of 17 weeks up to 75 mg Neramexane mesylate per day, 12 weeks follow-up. | Drug | 1 |
| PlaceboDouble-blind treatment period of 17 weeks placebo, 12 weeks follow-up. | Drug | 2 |
Primary outcome
TBF-12 (Tinnitus-Beeinträchtigungs-Fragebogen-12 "Tinnitus Handycap Inventory-12") total score change from baseline to end of treatment
Time frame: Screening, Baseline, week 5, 13, 17
2 secondary outcomes
TBF-12 factorial scores, individual respond rate, Tinnitus Rating Scale, Sleep Questionnaire, Qualitiy Of Life, population pharmacokinetics, optional pharmacogenetics
Time frame: 29 weeks
safety parameters
Time frame: 29 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2010.
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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.
The record lists no contact. Use the official record to reach the sponsor.
56 sites in 6 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 56 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. 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: finished, as of the sponsor's last update on 1 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 56 sites in Poland, Czechia, France, Belgium, Netherlands and 1 more country. 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. Some participants in this study may receive a placebo. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
TBF-12 (Tinnitus-Beeinträchtigungs-Fragebogen-12 "Tinnitus Handycap Inventory-12") total score change from baseline to end of treatment (time frame: Screening, Baseline, week 5, 13, 17). 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 1 Jul 2010.