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Completed

NCT Number: NCT00955799

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

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.

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Key information

Conditions

Subjective Tinnitus Ear Diseases Hearing Disorders Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Tinnitus

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Krankenhaus der Elisabethinen, Graz, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Neramexane mesylate

Drug

Double-blind treatment period of 29 weeks up to 75 mg Neramexane mesylate per day

Placebo

Drug

Double-blind treatment period of 29 weeks placebo

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. TBF-12 Total Score: Change from Baseline

    Time frame: Baseline to week 5, 17, 23, and 29

    See outcome measure #1.

  2. TBF-12 Factorial Scores: Change from Baseline

    Time frame: Baseline to week 5, 17, 23, and 29

    See outcome measure #1.

  3. 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.

  4. 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.

  5. Tinnitus Severity Scale (one week version): Change from Baseline

    Time frame: Baseline to week 5, 17, 23, and 29

    See outcome measure #2.

  6. 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".

  7. 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.

  8. 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".

Sponsors and collaborators

Lead sponsor

Merz Pharmaceuticals GmbH

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Aug 10, 2009
Registry last updated
Nov 28, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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