Subjective Tinnitus
Conditions
Keywords
Subjective, Tinnitus
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.
Interventions
Double-blind treatment period of 29 weeks up to 75 mg Neramexane mesylate per day
DRUGPlacebo
Double-blind treatment period of 29 weeks placebo
Sponsors
Merz Pharmaceuticals GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| TBF-12 Total Score: Change from Baseline | Baseline to week 5, 17, 23, and 29 | See outcome measure #1. |
| 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. |
| 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. |
| TBF-12 Factorial Scores: Change from Baseline | Baseline to week 5, 17, 23, and 29 | See outcome measure #1. |
Countries
Austria, Brazil, Germany, Mexico, United States
Outcome results
None listed