Subjective TinnitusPhase 3EASENCT00739635
Efficacy, Safety and Tolerability 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 54 sites in 5 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
- 411 participants
- Where
- 54 sitesin 5 countries
- Study dates
- Sep 2008to Feb 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 should never be absent for > 24 hours in a row), subjective, uni- or bilateral tinnitus 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, Menière's disease, otosclerosis, etc)
Trial locations and contacts
54 sites in 5 countries.
54 sites in 5 countries
Germany25 sites
Dr. med. Nobert Pasch
Aachen, 52074
Dr. Peter Küppers
Augsburg, 86199
Charité, Universitätsmedizin Berlin-Tinnituszentrum
Berlin, 10117
Klin. Forschung Berlin Buch GmbH
Berlin, 13125
Dr. med. Frank Reintjes
Braunschweig, 38100
ClinPharm International
Chemnitz, 09120
Dr. Klaus Peter Jayme
Darmstadt, 64283
Dr. Christian Dörr
Dresden, 01277
HNO-Praxis im Gesundheitszentrum Walsum
Duisburg, 47179
ClinPharm International GmbH
Frankfurt, 60596
ClinPharm International GmbH
Görlitz, 02826
Dr. Elisabeth Kühne
Halle, Saale, 06112
Dr. Werner Gieselmann
Heiligenhaus, 42579
Dr. Wolfgang Lotte
Iserlohn, 58642
ClinPharm International GmbH
Leipzig, 04103
HNO Praxis
Lichtenfels, 96215
Dr. Dannesberger
Lorsch, 64653
ClinPharm International
Magdeburg, 39104
HNO Gemeinschaftpraxis
Meppen, 48716
LMU München Klinik Großhadern
Munich
Dr. med. Ulrike Walter
Nuremberg, 90402
Dr. Susanne Wiedemann
Nuremberg, 90443
Dr. Norbert Staab
Schlüchtern, 36381
Dr. Hannelore Neumaier
Wiesbaden, 65183
Dr. med. Stephanie Göbel
Worms, 67547
Spain12 sites
Fundación Hospital de Alcorcón, Otorhinolaryngology
Alcorcón - Madrid, 28922
Hospital Clínico Barcelona, Dept. Of ORL
Barcelona, 08036
Clinica Clivina, Private Consultancy
Jaén
Hospital Comarcal San Agustin
Linares, Jaén, 23700
Hospital Xeral-Calde
Lugo
Hospital Puerta del Hierro, Madrid- Servicio de OR
Madrid, 28035
Hospital Universitario Príncipe de Asturias
Madrid, 28805
Hospital Universtiario Son Dureta
Palma de Mallorca, 07004
Clínica Universitaria de Navarra, Dept. ORL
Pamplona, Navarre, 31008
Hospital Sagunto
Sagunto, Valencia, 46520
Hospital Universitario de Salamanca- Hospital Virgen de la Vega
Salamanca, 37007
Hospital Universitario Virgen del Rocio- Centro de Especialidades Dr. Fleming
Seville, 41005
United Kingdom10 sites
Oldfield Surgery
Bath, BA2 3HT
Avondale Surgery Research office
Chesterfield, S40 4TF
The Horsley Medical Practice
East Horsley, Leatherhead, Surrey, KT24 6QT
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
Dr. Trevor Gooding
Warwick Shire, CV9 1EU
Sherbourne Medical Centre
Warwickshire, CV32 4RA
Austria5 sites
Krankenhaus der Elisabethinen
Graz, A-8020
Bezirkskrankenhaus Kufstein
Kufstein, A-6330
A. ö. Krankenhaus der Elisabethinen Linz
Linz, A-4010
Salzburger Landeskrankenhaus, Universitätsklinik für Hals-Nasen-Ohren-Krankheiten
Salzburg, A-5020
Clin Pharm International GmbH, Zentrum Wien
Vienna, A-1090
Portugal2 sites
Hospital Militar Regional nº 1 Serviço de Otorrinolaringologia
Porto, 4050-113
Clínica ORL Dr. Eurico de Almeida
Porto, 4050-115
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
PlaceboDrug
Double-blind treatment period of 17 weeks placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Neramexane mesylate |
| 2 | Placebo comparator | Not described 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 Handicap 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 responder rate, Tinnitus Rating Scale, Sleep Questionnaire, population pharmacokinetics, optional pharmacogenetics
Measured: 17 weeks
safety parameters
Measured: 17 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2008 (estimated)
- Study startSep 2008
- Primary completionFeb 2010
- Study completionFeb 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 411 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merz Pharmaceuticals GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00739635
- Sponsor's protocol ID
- MRZ 92579/TI/3001
- Other IDs
- EudraCT Number 2007-007835-16
- Acronym
- EASE
- Status last verified
- Feb 2016
- First submitted
- 21 Aug 2008
- Last updated
- 4 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2016. 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
- NCT00739635
- Acronym / sponsor ID
- EASE / MRZ 92579/TI/3001
- Conditions
- Subjective Tinnitus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 411 participants (actual)
- Lead sponsor
- Merz Pharmaceuticals GmbHIndustry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 22 Aug 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
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Neramexane mesylate |
| 2 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients aged 18 to 75 years with a clinical diagnosis of first onset,
- Persistent (i.e. tinnitus should never be absent for > 24 hours in a row), subjective, uni- or bilateral tinnitus 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, Menière'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 | Drug | 1 |
| PlaceboDouble-blind treatment period of 17 weeks placebo | Drug | 2 |
Primary outcome
TBF-12 (Tinnitus-Beeinträchtigungs-Fragebogen-12 "Tinnitus Handicap 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 responder rate, Tinnitus Rating Scale, Sleep Questionnaire, population pharmacokinetics, optional pharmacogenetics
Time frame: 17 weeks
safety parameters
Time frame: 17 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 4 Feb 2016.
- Related InfoLink provided by the sponsor.
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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.
54 sites in 5 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 54 sites in 5 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 2 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 4 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 54 sites in Germany, Spain, United Kingdom, Austria, Portugal. 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 Handicap 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 4 Feb 2016.