Efficacy, Safety, Tolerability of Neramexane in Patients With Subjective Tinnitus - Full Text View

Purpose

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	Intervention	Phase
Subjective Tinnitus	Drug: Neramexane mesylate Drug: Placebo	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

MedlinePlus related topics: Tinnitus

U.S. FDA Resources

Further study details as provided by Merz Pharmaceuticals GmbH:

Primary Outcome Measures:

Absolute Change in TBF-12 (Tinnitus Handicap Inventory-12) Total Score from Baseline. [ Time Frame: Baseline to week 17 and 29 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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:

TBF-12 Total Score: Change from Baseline [ Time Frame: Baseline to week 5, 17, 23, and 29 ] [ Designated as safety issue: No ]
See outcome measure #1.
TBF-12 Factorial Scores: Change from Baseline [ Time Frame: Baseline to week 5, 17, 23, and 29 ] [ Designated as safety issue: No ]
See outcome measure #1.
TBF-12: Individual Responder Rate [ Time Frame: Week 5, 17, 23, and 29 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
See outcome measure #2.
Attention and Performance Self-Assessment (ASPA) Questionnaire: Change from Baseline [ Time Frame: Baseline to week 5, 17, 23, and 29 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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".


Enrollment:	455
Study Start Date:	September 2009
Study Completion Date:	June 2011
Primary Completion Date:	May 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility


Ages Eligible for Study:	18 Years to 75 Years (Adult, Senior)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00955799

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Sponsors and Collaborators

Merz Pharmaceuticals GmbH

Investigators


Study Director:	Medical Expert	Merz Pharmaceuticals

More Information


Responsible Party:	Merz Pharmaceuticals GmbH
ClinicalTrials.gov Identifier:	NCT00955799 History of Changes
Other Study ID Numbers:	MRZ 92579/TI/3003 2009-011246-25
Study First Received:	August 6, 2009
Last Updated:	November 27, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Merz Pharmaceuticals GmbH:


Subjective, Tinnitus

Additional relevant MeSH terms:


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

ClinicalTrials.gov processed this record on September 30, 2016