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)
Horizon Clinical Research Associates PLLC
🇺🇸Gilbert, Arizona, United States
Phoenix Clinical
🇺🇸Phoenix, Arizona, United States
Paradigm Clinical Research
🇺🇸Tucson, Arizona, United States
Providence Clinical Research
🇺🇸Burbank, California, United States
Central California Clinical Research
🇺🇸Fresno, California, United States
UC Davis Health System
🇺🇸Sacramento, California, 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
Tampa Bay Medical Research
🇺🇸Clearwater, Florida, United States
Scroll for more (64 remaining)Horizon Clinical Research Associates PLLC🇺🇸Gilbert, Arizona, United States