Efficacy, Safety, Tolerability of Neramexane in Patients With Subjective Tinnitus

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Double-Blind, Placebo-Controlled, Clinical Evaluation of the Efficacy, Safety and Tolerability of Neramexane in Patients With Subjective Tinnitus

Conditions
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Subjective Tinnitus

Intervention / Treatment
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* Drug: Neramexane mesylate
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Neramexane mesylate<br>Double-blind treatment period of 29 weeks up to 75 mg Neramexane mesylate per day | Drug: Neramexane mesylate<br>* Double-blind treatment period of 29 weeks up to 75 mg Neramexane mesylate per day<br>|
| Placebo Comparator: Placebo<br>Placebo: identical placebo tablets | Drug: Placebo<br>* Double-blind treatment period of 29 weeks placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Baseline to week 17 and 29 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TBF-12 Total Score: Change from Baseline | See outcome measure #1. | Baseline to week 5, 17, 23, and 29 | 
| TBF-12 Factorial Scores: Change from Baseline | See outcome measure #1. | 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. | 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. | Baseline to week 5, 17, 23, and 29 | 
| Tinnitus Severity Scale (one week version): Change from Baseline | See outcome measure #2. | 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. | 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. | 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. | Baseline to week 17 and 29 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Subjective, Tinnitus