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

• Sponsor: Merz Pharmaceuticals GmbH
• Information provided by (Responsible Party): Merz Pharmaceuticals GmbH

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Subjective Tinnitus	Drug: Neramexane mesylate; Drug: Placebo	Phase 3

Study Design

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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

Arms and Interventions

Arm	Intervention/treatment
Experimental: Neramexane mesylate; Double-blind treatment period of 29 weeks up to 75 mg Neramexane mesylate per day	Drug: Neramexane mesylate; Double-blind treatment period of 29 weeks up to 75 mg Neramexane mesylate per day
Placebo Comparator: Placebo; Placebo: identical placebo tablets	Drug: Placebo; Double-blind treatment period of 29 weeks placebo

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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".

Eligibility Criteria

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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

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)

Contacts and Locations

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Sponsors and Collaborators

Merz Pharmaceuticals GmbH

Investigators

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Study Director:	Medical Expert	Merz Pharmaceuticals

More Information

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Responsible Party:	Merz Pharmaceuticals GmbH
ClinicalTrials.gov Identifier:	NCT00955799 History of Changes
Other Study ID Numbers:	MRZ 92579/TI/3003; 2009-011246-25 ( EudraCT Number )
First Posted:	August 10, 2009
Last Update Posted:	November 28, 2012
Last Verified:	November 2012

Keywords provided by Merz Pharmaceuticals GmbH:

Subjective, Tinnitus

Additional relevant MeSH terms:

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Tinnitus; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases	Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms