Subjective TinnitusPhase 3NCT00955799
Efficacy, Safety, 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 76 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
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 455 participants
- Where
- 76 sitesin 5 countries
- Study dates
- Sep 2009to Jun 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:
- Patients aged between 18 and 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 subacute tinnitus
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, Menière's disease, otosclerosis, etc)
Trial locations and contacts
76 sites in 5 countries.
76 sites in 5 countries
United States39 sites
Austin Ear, Nose and Throat Clinic
Austin, Texas, 78705
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; State University of New York at Buffalo
Buffalo, New York, 14221
Providence Clinical Research
Burbank, California, 91505
Cary Medical Research
Cary, North Carolina, 27518
Medical University of South Carlolina, Otolaryngology
Charleston, South Carolina, 29425
Tampa Bay Medical Research
Clearwater, Florida, 33761
Colorado Otolaryngology Associates
Colorado Springs, Colorado, 80909
FutureSearch Trials of Dallas
Dallas, Texas, 75231
Deaconess Clinic, Inc.
Evansville, Indiana, 47710
MediSphere Medical Research Center, LLC
Evansville, Indiana, 47714
Central California Clinical Research
Fresno, California, 93720
Horizon Clinical Research Associates PLLC
Gilbert, Arizona, 85295
New West Physicians
Golden, Colorado, 80401
Deerpath Physicians Group
Gurnee, Illinois, 60031
University of Iowa Hospitals & Clinics
Iowa City, Iowa, 52242-1078
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
Deaconess Clinic, Inc.
Newburgh, Indiana, 47630
Health Research of Hampton Roads, Inc.
Newport News, Virginia, 23606
Knight Center for Integrated Health
Peoria, Illinois, 61614
Phoenix Clinical
Phoenix, Arizona, 85015
Research Across America
Plano, Texas, 75093
Wake Research Associates, LLC
Raleigh, North Carolina, 27612
UC Davis Health System
Sacramento, California, 95817
David L. Bortniker
Somerville, New Jersey, 08876
Clinical Research of West Florida, Inc.
Tampa, Florida, 33603
Montefiore Medical 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
Mexico14 sites
Instituto Biomédico de Investigación A.C.
Aguascalientes, CP 20127
Hospital General de Chihuahua
Chihuahua City, C.P. 31000
Hospital Christus Muguerza del Parque
Chihuahua City, CP 3100
Clinical Research Instutute S.C.
Edo. de México, CP 54055
Hospital Civil de Guadalajara "Fray Antonio Alcalde", Servicio de Otorrinolaringología; Hospital No. 278
Guadalajara Jalisco, CP 44280
Grupo Médico Terranova
Guadalajara Jalisco, CP 44630
Unidad de Investigación Clínica Cardiometábolica de Occidente S.C. (UNICAMO)
Jalisco, 44150
Hospital General de México S.S. O.D.; Servicio de Otorrinolaringología
México D.F., 06726
Hospital OCA Monterrey International Research Center (MIRC)
Nuevo León, CP 64000
Hospital Universitario
Nuevo León, CP 64400
Unidad de Tratamientos Avanzados (UTRAV) S.C.
Nuevo León, CP64240
Hospital Central "Dr. Ignacio Morones Prieto"; Servicio de Otorrinolaringología
San Luis Potosí City, 78240
Medicentro del Parque
San Luis Potosí City, C.P. 78269
Unidad Médica de Especialidades del Noroeste (UMEN)
Sinaloa, 80000
Germany12 sites
Klin. Forschung Berlin Buch GmbH
Berlin, 13125
Praxis im Schlosscarree
Braunschweig, 38100
Dr. Klaus Peter Jayme
Darmstadt, 64283
Dr. Christian Dörr
Dresden, 01277
Dr. Elisabeth Kühne
Halle, 06112
Dr. Werner Gieselmann
Heiligenhaus, 42579
Dr. Wolfgang Lotte
Iserlohn, 58642
ClinPharm International GmbH
Leipzig, 04103
HNO Praxis, Bamberger Str. 7
Lichtenfels, 96215
Dr. Dannesberger
Lorsch, 64653
LMU München, Klinikum Großhadern
München, 81377
Dr. Susanne Wiedemann
Nuremberg, 90443
Brazil7 sites
Consultório Dr. Marcelo Rates
Belo Horizonte, 30150-270
Instituto de Otorrinolaringologia Linhares
Rio de Janeiro
Hospital de Clinicas de Porto Alegre
Rio Grande, 90035-001
Faculdade de Medicina do ABC
Santo André/SP
Universidade Federal de São Paulo - UNIFESP
Sao Paulo/ SP
Instituto Ganz Sanchez
São Paulo/SP, 05469-000
Clínica OTOSUL
Valença
Austria4 sites
Krankenhaus der Elisabethinen
Graz, 8020
Bezirkskrankenhaus Kufstein
Kufstein, 6330
A. ö. Krankenhaus der Elisabethinen Linz
Linz, 4010
Clin Pharm International GmbH, Zentrum Wien
Vienna, 1090
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
- Keywords
- Subjective, Tinnitus
- 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 29 weeks up to 75 mg Neramexane mesylate per day
PlaceboDrug
Double-blind treatment period of 29 weeks placebo
| Study group | Role | What they receive |
|---|---|---|
| Neramexane mesylate | Experimental | Double-blind treatment period of 29 weeks up to 75 mg Neramexane mesylate per day Receives: Drug: Neramexane mesylate |
| Placebo | Placebo comparator | Placebo: identical placebo tablets Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute Change in TBF-12 (Tinnitus Handicap Inventory-12) Total Score from Baseline.
The TBF-12 is an adapted German version of the original English THI (Tinnitus Handicap Inventory). It is a self-report questionnaire assessing 12 items from 2 dimensions: emotional-cognitive factors and functional-communicational factors. Each item is rated with 0-2 (2= "often"; 1= "sometimes"; 0= "never"). The maximum score is 24 indicating most severe tinnitus impairment.
Hierarchical test procedure: Step 1: week 29 in subjects reporting acute hearing loss; step 2: week 17, ditto; step 3: week 29 in total population; step 4: week 17, ditto.
Measured: Baseline to week 17 and 29
Absolute Change in TSSw (Tinnitus Severity Scale - One Week Version) Total Score from Baseline.
The TSSw is a measure of tinnitus severity. It will be self-evaluated by the patient at various time points on an 11-point Likert-like scale asking for the past week. The scores range from 0 (indicating no tinnitus) to the maximum score of 10 (characterizing the most severe tinnitus considered).
Hierarchical test procedure: Step 1: week 29 in subjects reporting acute hearing loss; step 2: week 17, ditto; step 3: week 29 in total population; step 4: week 17, ditto.
Measured: Baseline to week 17 and 29
Secondary outcomes (8)
TBF-12 Total Score: Change from Baseline
See outcome measure #1.
Measured: Baseline to week 5, 17, 23, and 29
TBF-12 Factorial Scores: Change from Baseline
See outcome measure #1.
Measured: Baseline to week 5, 17, 23, and 29
TBF-12: Individual Responder Rate
See outcome measure #1. A subject is considered responder if TBF-12 decreases at least 4 score points between baseline and respective visit.
Measured: Week 5, 17, 23, and 29
Tinnitus Rating Scale (one week version): Change from Baseline
Tinnitus Rating Scale is a self-evaluated 11-point Likert scale assessing tinnitus loudness, annoyance, and impact on life. The scores range from 0 (no impact), to the maximum score of 10 (worst influence of the problem considered). Single scores and sum scores will be analysed.
Measured: Baseline to week 5, 17, 23, and 29
Tinnitus Severity Scale (one week version): Change from Baseline
See outcome measure #2.
Measured: Baseline to week 5, 17, 23, and 29
Attention and Performance Self-Assessment (ASPA) Questionnaire: Change from Baseline
The ASPA consists of 30 simple statements for which the patient can determine how regular this happens to him/her. The response options for each statement are "never", "seldom", "sometimes", "often" and "always".
Measured: Baseline to week 5, 17, 23, and 29
Quality of Life Questionnaire (SF-36™ Health Survey): Change from Baseline
The SF-36 is a multipurpose health survey with 36 questions. It is a generic measure commonly used in general and specific populations, comparing the relative burden of diseases, and in differentiating the health benefits produced by a wide range of different treatments.
Measured: Baseline to week 17 and 29
Hospital Anxiety and Depression Scale (HADS): Change from Baseline
The HADS is a self-assessment scale with 14 items which has been developed for non psychiatrists to detect states of depression and anxiety in a hospital outpatient population. Every item is rated with a scale (3= very often indeed; 2= quite often; 1= not very often; 0= not at all). Lower total scores indicate "normal", higher total scores "abnormal".
Measured: Baseline to week 17 and 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2009 (estimated)
- Study startSep 2009
- Primary completionMay 2011
- Study completionJun 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 455 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
- NCT00955799
- Sponsor's protocol ID
- MRZ 92579/TI/3003
- Other IDs
- 2009-011246-25, 2009
- Status last verified
- Nov 2012
- First submitted
- 6 Aug 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
- A Randomized, Double-Blind, Placebo-Controlled, Clinical Evaluation of the Efficacy, Safety and Tolerability of Neramexane in Patients With Subjective Tinnitus
- ClinicalTrials.gov ID
- NCT00955799
- Acronym / sponsor ID
- MRZ 92579/TI/3003
- Conditions
- Subjective Tinnitus
- Keywords
- Subjective, Tinnitus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 455 participants (actual)
- Lead sponsor
- Merz Pharmaceuticals GmbHIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- May 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 10 Aug 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 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 |
|---|---|---|
| Neramexane mesylate | Experimental | Drug: Neramexane mesylateDouble-blind treatment period of 29 weeks up to 75 mg Neramexane mesylate per day |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo: identical placebo tablets |
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 mesylateDouble-blind treatment period of 29 weeks up to 75 mg Neramexane mesylate per day | Drug | Neramexane mesylate |
| PlaceboDouble-blind treatment period of 29 weeks placebo | Drug | Placebo |
Primary outcome
Absolute Change in TBF-12 (Tinnitus Handicap Inventory-12) Total Score from Baseline.
Time frame: Baseline to week 17 and 29
The TBF-12 is an adapted German version of the original English THI (Tinnitus Handicap Inventory). It is a self-report questionnaire assessing 12 items from 2 dimensions: emotional-cognitive factors and functional-communicational factors. Each item is rated with 0-2 (2= "often"; 1= "sometimes"; 0= "never"). The maximum score is 24 indicating most severe tinnitus impairment. Hierarchical test procedure: Step 1: week 29 in subjects reporting acute hearing loss; step 2: week 17, ditto; step 3: week 29 in total population; step 4: week 17, ditto.
Absolute Change in TSSw (Tinnitus Severity Scale - One Week Version) Total Score from Baseline.
Time frame: Baseline to week 17 and 29
The TSSw is a measure of tinnitus severity. It will be self-evaluated by the patient at various time points on an 11-point Likert-like scale asking for the past week. The scores range from 0 (indicating no tinnitus) to the maximum score of 10 (characterizing the most severe tinnitus considered). Hierarchical test procedure: Step 1: week 29 in subjects reporting acute hearing loss; step 2: week 17, ditto; step 3: week 29 in total population; step 4: week 17, ditto.
8 secondary outcomes
TBF-12 Total Score: Change from Baseline
Time frame: Baseline to week 5, 17, 23, and 29
TBF-12 Factorial Scores: Change from Baseline
Time frame: Baseline to week 5, 17, 23, and 29
TBF-12: Individual Responder Rate
Time frame: Week 5, 17, 23, and 29
Tinnitus Rating Scale (one week version): Change from Baseline
Time frame: Baseline to week 5, 17, 23, and 29
Tinnitus Severity Scale (one week version): Change from Baseline
Time frame: Baseline to week 5, 17, 23, and 29
Attention and Performance Self-Assessment (ASPA) Questionnaire: Change from Baseline
Time frame: Baseline to week 5, 17, 23, and 29
Quality of Life Questionnaire (SF-36™ Health Survey): Change from Baseline
Time frame: Baseline to week 17 and 29
Hospital Anxiety and Depression Scale (HADS): Change from Baseline
Time frame: Baseline to week 17 and 29
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 28 Nov 2012.
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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
76 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 76 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?
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 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 76 sites in United States, Mexico, Germany, Brazil, Austria. 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?
Absolute Change in TBF-12 (Tinnitus Handicap Inventory-12) Total Score from Baseline. (time frame: Baseline to week 17 and 29). The study lists 2 primary outcomes in all. 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.