Efficacy, Safety, Tolerability of Neramexane in Patients With Subjective Tinnitus
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| ClinicalTrials.gov Identifier: NCT00955799 |
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Recruitment Status :
Completed
First Posted : August 10, 2009
Last Update Posted : November 28, 2012
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Subjective Tinnitus | Drug: Neramexane mesylate Drug: Placebo | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 455 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Clinical Evaluation of the Efficacy, Safety and Tolerability of Neramexane in Patients With Subjective Tinnitus |
| Study Start Date : | September 2009 |
| Actual Primary Completion Date : | May 2011 |
| Actual Study Completion Date : | June 2011 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Neramexane mesylate
Double-blind treatment period of 29 weeks up to 75 mg Neramexane mesylate per day
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Drug: Neramexane mesylate
Double-blind treatment period of 29 weeks up to 75 mg Neramexane mesylate per day |
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Placebo Comparator: Placebo
Placebo: identical placebo tablets
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Drug: Placebo
Double-blind treatment period of 29 weeks placebo |
- Absolute Change in TBF-12 (Tinnitus Handicap Inventory-12) Total Score from Baseline. [ Time Frame: 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. [ Time Frame: 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.
- TBF-12 Total Score: Change from Baseline [ Time Frame: Baseline to week 5, 17, 23, and 29 ]See outcome measure #1.
- TBF-12 Factorial Scores: Change from Baseline [ Time Frame: Baseline to week 5, 17, 23, and 29 ]See outcome measure #1.
- TBF-12: Individual Responder Rate [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Baseline to week 5, 17, 23, and 29 ]See outcome measure #2.
- Attention and Performance Self-Assessment (ASPA) Questionnaire: Change from Baseline [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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".
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| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00955799
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| Study Director: | Medical Expert | Merz Pharmaceuticals |
| Responsible Party: | Merz Pharmaceuticals GmbH |
| ClinicalTrials.gov Identifier: | NCT00955799 |
| Other Study ID Numbers: |
MRZ 92579/TI/3003 2009-011246-25 ( EudraCT Number ) |
| First Posted: | August 10, 2009 Key Record Dates |
| Last Update Posted: | November 28, 2012 |
| Last Verified: | November 2012 |
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Subjective, Tinnitus |
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Tinnitus Hearing Disorders Ear Diseases Otorhinolaryngologic Diseases |
Sensation Disorders Neurologic Manifestations Nervous System Diseases |