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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
455
Double-blind treatment period of 29 weeks up to 75 mg Neramexane mesylate per day
Double-blind treatment period of 29 weeks placebo
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.
Time frame: 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.
Time frame: Baseline to week 17 and 29
TBF-12 Total Score: Change from Baseline
See outcome measure #1.
Time frame: Baseline to week 5, 17, 23, and 29
TBF-12 Factorial Scores: Change from Baseline
See outcome measure #1.
Time frame: 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.
Time frame: Week 5, 17, 23, and 29
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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
...and 66 more locations
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.
Time frame: Baseline to week 5, 17, 23, and 29
Tinnitus Severity Scale (one week version): Change from Baseline
See outcome measure #2.
Time frame: 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".
Time frame: 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.
Time frame: 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".
Time frame: Baseline to week 17 and 29