Efficacy, Safety, Tolerability of Neramexane in Patients With Subjective Tinnitus
- Registration Number
- NCT00955799
- Lead Sponsor
- Merz Pharmaceuticals GmbH
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 455
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Neramexane mesylate Neramexane mesylate Double-blind treatment period of 29 weeks up to 75 mg Neramexane mesylate per day Placebo Placebo Placebo: identical placebo tablets
- Primary Outcome Measures
Name Time Method Absolute Change in TBF-12 (Tinnitus Handicap Inventory-12) Total Score from Baseline. 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. 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.
- Secondary Outcome Measures
Name Time Method TBF-12 Total Score: Change from Baseline Baseline to week 5, 17, 23, and 29 See outcome measure #1.
TBF-12 Factorial Scores: Change from Baseline Baseline to week 5, 17, 23, and 29 See outcome measure #1.
TBF-12: Individual Responder Rate Week 5, 17, 23, and 29 See outcome measure #1. A subject is considered responder if TBF-12 decreases at least 4 score points between baseline and respective visit.
Tinnitus Rating Scale (one week version): Change from Baseline Baseline to week 5, 17, 23, and 29 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.
Tinnitus Severity Scale (one week version): Change from Baseline Baseline to week 5, 17, 23, and 29 See outcome measure #2.
Attention and Performance Self-Assessment (ASPA) Questionnaire: Change from Baseline Baseline to week 5, 17, 23, and 29 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".
Quality of Life Questionnaire (SF-36™ Health Survey): Change from Baseline Baseline to week 17 and 29 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.
Hospital Anxiety and Depression Scale (HADS): Change from Baseline Baseline to week 17 and 29 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".
Trial Locations
- Locations (74)
Glacier Ear, Nose, and Throat, Head and Neck Surgery, P.C.
🇺🇸Kalispell, Montana, United States
FutureSearch Trials of Dallas
🇺🇸Dallas, Texas, United States
Wake Research Associates, LLC
🇺🇸Raleigh, North Carolina, United States
Hospital Central "Dr. Ignacio Morones Prieto"; Servicio de Otorrinolaringología
🇲🇽San Luis Potosí, Mexico
Heartland Research Associates, LLC.
🇺🇸Wichita, Kansas, United States
Consultório Dr. Marcelo Rates
🇧🇷Bello Horizonte, Brazil
Knight Center for Integrated Health
🇺🇸Peoria, Illinois, United States
Hospital Christus Muguerza del Parque
🇲🇽Chihuahua, Mexico
Universidade Federal de São Paulo - UNIFESP
🇧🇷Sao Paulo/ SP, Brazil
ClinPharm International GmbH
🇩🇪Leipzig, Germany
Praxis im Schlosscarree
🇩🇪Braunschweig, Germany
Phoenix Clinical
🇺🇸Phoenix, Arizona, United States
Grupo Médico Terranova
🇲🇽Guadalajara Jalisco, Mexico
Horizon Clinical Research Associates PLLC
🇺🇸Gilbert, Arizona, United States
UC Davis Health System
🇺🇸Sacramento, California, United States
Central California Clinical Research
🇺🇸Fresno, California, United States
Providence Clinical Research
🇺🇸Burbank, California, United States
Paradigm Clinical Research
🇺🇸Tucson, Arizona, United States
Colorado Otolaryngology Associates
🇺🇸Colorado Springs, Colorado, United States
New West Physicians
🇺🇸Golden, Colorado, United States
Visions Clinical Research
🇺🇸Boynton Beach,, Florida, United States
Clinical Research of West Florida, Inc.
🇺🇸Tampa, Florida, United States
Deaconess Clinic, Inc.
🇺🇸Newburgh, Indiana, United States
MediSphere Medical Research Center, LLC
🇺🇸Evansville, Indiana, United States
Tampa Bay Medical Research
🇺🇸Clearwater, Florida, United States
Commonwealth Ear, Nose & Throat
🇺🇸Louisville, Kentucky, United States
University of Iowa Hospitals & Clinics
🇺🇸Iowa City, Iowa, United States
Deerpath Physicians Group
🇺🇸Gurnee, Illinois, United States
University of Kansas; Department of Otolaryngology Head & Neck Surgery
🇺🇸Kansas City, Kansas, United States
David L. Bortniker
🇺🇸Somerville, New Jersey, United States
Immedicenter
🇺🇸Bloomfield, New Jersey, United States
Erie County Medical Center, Department of Rehabilitation Medicine; State University of New York at Buffalo
🇺🇸Buffalo, New York, United States
Cary Medical Research
🇺🇸Cary, North Carolina, United States
Wilmington Medical Research
🇺🇸Wilmington, North Carolina, United States
Piedmont Medical Research
🇺🇸Winston-Salem, North Carolina, United States
Medical University of South Carlolina, Otolaryngology
🇺🇸Charleston, South Carolina, United States
Austin Ear, Nose and Throat Clinic
🇺🇸Austin, Texas, United States
Future Search Trials of Neurology
🇺🇸Austin, Texas, United States
R/D Clinical Research, Inc.
🇺🇸Lake Jackson, Texas, United States
South Texas Research Alliance LLC
🇺🇸Laredo, Texas, United States
Research Across America
🇺🇸Plano, Texas, United States
Health Research of Hampton Roads, Inc.
🇺🇸Newport News, Virginia, United States
Advanced Clinical Research
🇺🇸West Jordon, Utah, United States
Krankenhaus der Elisabethinen
🇦🇹Graz, Austria
Bezirkskrankenhaus Kufstein
🇦🇹Kufstein, Austria
A. ö. Krankenhaus der Elisabethinen Linz
🇦🇹Linz, Austria
Clin Pharm International GmbH, Zentrum Wien
🇦🇹Wien, Austria
Clínica OTOSUL
🇧🇷Valenca, Brazil
Hospital de Clinicas de Porto Alegre
🇧🇷Rio Grande do Sul, Brazil
Faculdade de Medicina do ABC
🇧🇷Santo André/SP, Brazil
Instituto Ganz Sanchez
🇧🇷São Paulo/SP, Brazil
Instituto de Otorrinolaringologia Linhares
🇧🇷Rio de Janeiro, Brazil
Klin. Forschung Berlin Buch GmbH
🇩🇪Berlin, Germany
Dr. Elisabeth Kühne
🇩🇪Halle/ Saale, Germany
Dr. Klaus Peter Jayme
🇩🇪Darmstadt, Germany
Dr. Wolfgang Lotte
🇩🇪Iserlohn, Germany
Dr. Werner Gieselmann
🇩🇪Heiligenhaus, Germany
Dr. Christian Dörr
🇩🇪Dresden, Germany
HNO Praxis, Bamberger Str. 7
🇩🇪Lichtenfels, Germany
Dr. Dannesberger
🇩🇪Lorsch, Germany
LMU München, Klinikum Großhadern
🇩🇪München, Germany
Instituto Biomédico de Investigación A.C.
🇲🇽Aguascalientes, Mexico
Dr. Susanne Wiedemann
🇩🇪Nürnberg, Germany
Clinical Research Instutute S.C.
🇲🇽Edo. de México, Mexico
Hospital General de Chihuahua
🇲🇽Chihuahua, Mexico
Hospital Civil de Guadalajara "Fray Antonio Alcalde", Servicio de Otorrinolaringología; Hospital No. 278
🇲🇽Guadalajara Jalisco, Mexico
Hospital General de México S.S. O.D.; Servicio de Otorrinolaringología
🇲🇽México D.F., Mexico
Unidad de Tratamientos Avanzados (UTRAV) S.C.
🇲🇽Nuevo León, Mexico
Unidad de Investigación Clínica Cardiometábolica de Occidente S.C. (UNICAMO)
🇲🇽Jalisco, Mexico
Hospital OCA Monterrey International Research Center (MIRC)
🇲🇽Nuevo León, Mexico
Hospital Universitario
🇲🇽Nuevo León, Mexico
Unidad Médica de Especialidades del Noroeste (UMEN)
🇲🇽Sinaloa, Mexico
Medicentro del Parque
🇲🇽San Luis Potosí, Mexico
Montefiore Medical Center
🇺🇸Bronx, New York, United States