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

Subjective Tinnitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00955799
• Other study ID #: MRZ 92579/TI/3003
• Secondary ID: 2009-011246-25
• Status: Completed
• Phase: Phase 3
• First received: August 6, 2009
• Last updated: November 27, 2012
• Start date: September 2009
• Est. completion date: June 2011

Study information

• Verified date: November 2012
• Source: Merz Pharmaceuticals GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 455
• Est. completion date: June 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Subjective Tinnitus
• Tinnitus

Intervention

Drug:
• Neramexane mesylate
Double-blind treatment period of 29 weeks up to 75 mg Neramexane mesylate per day
• Placebo
Double-blind treatment period of 29 weeks placebo

Locations

Country	Name	City	State
Austria	Krankenhaus der Elisabethinen	Graz
Austria	Bezirkskrankenhaus Kufstein	Kufstein
Austria	A. ö. Krankenhaus der Elisabethinen Linz	Linz
Austria	Clin Pharm International GmbH, Zentrum Wien	Wien
Brazil	Consultório Dr. Marcelo Rates	Bello Horizonte
Brazil	Instituto de Otorrinolaringologia Linhares	Rio de Janeiro
Brazil	Hospital de Clinicas de Porto Alegre	Rio Grande do Sul
Brazil	Faculdade de Medicina do ABC	Santo André/SP
Brazil	Universidade Federal de São Paulo - UNIFESP	Sao Paulo/ SP
Brazil	Instituto Ganz Sanchez	São Paulo/SP
Brazil	Clínica OTOSUL	Valenca
Germany	Klin. Forschung Berlin Buch GmbH	Berlin
Germany	Praxis im Schlosscarree	Braunschweig
Germany	Dr. Klaus Peter Jayme	Darmstadt
Germany	Dr. Christian Dörr	Dresden
Germany	Dr. Elisabeth Kühne	Halle/ Saale
Germany	Dr. Werner Gieselmann	Heiligenhaus
Germany	Dr. Wolfgang Lotte	Iserlohn
Germany	ClinPharm International GmbH	Leipzig
Germany	HNO Praxis, Bamberger Str. 7	Lichtenfels
Germany	Dr. Dannesberger	Lorsch
Germany	LMU München, Klinikum Großhadern	München
Germany	Dr. Susanne Wiedemann	Nürnberg
Mexico	Instituto Biomédico de Investigación A.C.	Aguascalientes
Mexico	Hospital Christus Muguerza del Parque	Chihuahua
Mexico	Hospital General de Chihuahua	Chihuahua
Mexico	Clinical Research Instutute S.C.	Edo. de México
Mexico	Grupo Médico Terranova	Guadalajara Jalisco
Mexico	Hospital Civil de Guadalajara "Fray Antonio Alcalde", Servicio de Otorrinolaringología; Hospital No. 278	Guadalajara Jalisco
Mexico	Unidad de Investigación Clínica Cardiometábolica de Occidente S.C. (UNICAMO)	Jalisco
Mexico	Hospital General de México S.S. O.D.; Servicio de Otorrinolaringología	México D.F.
Mexico	Hospital OCA Monterrey International Research Center (MIRC)	Nuevo León
Mexico	Hospital Universitario	Nuevo León
Mexico	Unidad de Tratamientos Avanzados (UTRAV) S.C.	Nuevo León
Mexico	Hospital Central "Dr. Ignacio Morones Prieto"; Servicio de Otorrinolaringología	San Luis Potosí
Mexico	Medicentro del Parque	San Luis Potosí
Mexico	Unidad Médica de Especialidades del Noroeste (UMEN)	Sinaloa
United States	Austin Ear, Nose and Throat Clinic	Austin	Texas
United States	Future Search Trials of Neurology	Austin	Texas
United States	Immedicenter	Bloomfield	New Jersey
United States	Visions Clinical Research	Boynton Beach,	Florida
United States	Montefiore Medical Center	Bronx	New York
United States	Erie County Medical Center, Department of Rehabilitation Medicine; State University of New York at Buffalo	Buffalo	New York
United States	Providence Clinical Research	Burbank	California
United States	Cary Medical Research	Cary	North Carolina
United States	Medical University of South Carlolina, Otolaryngology	Charleston	South Carolina
United States	Tampa Bay Medical Research	Clearwater	Florida
United States	Colorado Otolaryngology Associates	Colorado Springs	Colorado
United States	FutureSearch Trials of Dallas	Dallas	Texas
United States	Deaconess Clinic, Inc.	Evansville	Indiana
United States	MediSphere Medical Research Center, LLC	Evansville	Indiana
United States	Central California Clinical Research	Fresno	California
United States	Horizon Clinical Research Associates PLLC	Gilbert	Arizona
United States	New West Physicians	Golden	Colorado
United States	Deerpath Physicians Group	Gurnee	Illinois
United States	University of Iowa Hospitals & Clinics	Iowa City	Iowa
United States	Glacier Ear, Nose, and Throat, Head and Neck Surgery, P.C.	Kalispell	Montana
United States	University of Kansas; Department of Otolaryngology Head & Neck Surgery	Kansas City	Kansas
United States	R/D Clinical Research, Inc.	Lake Jackson	Texas
United States	South Texas Research Alliance LLC	Laredo	Texas
United States	Commonwealth Ear, Nose & Throat	Louisville	Kentucky
United States	Deaconess Clinic, Inc.	Newburgh	Indiana
United States	Health Research of Hampton Roads, Inc.	Newport News	Virginia
United States	Knight Center for Integrated Health	Peoria	Illinois
United States	Phoenix Clinical	Phoenix	Arizona
United States	Research Across America	Plano	Texas
United States	Wake Research Associates, LLC	Raleigh	North Carolina
United States	UC Davis Health System	Sacramento	California
United States	David L. Bortniker	Somerville	New Jersey
United States	Clinical Research of West Florida, Inc.	Tampa	Florida
United States	Paradigm Clinical Research	Tucson	Arizona
United States	Advanced Clinical Research	West Jordon	Utah
United States	Heartland Research Associates, LLC.	Wichita	Kansas
United States	Heartland Research Associates, LLC.	Wichita	Kansas
United States	Wilmington Medical Research	Wilmington	North Carolina
United States	Piedmont Medical Research	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Merz Pharmaceuticals GmbH

Countries where clinical trial is conducted

United States,  Austria,  Brazil,  Germany,  Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	TBF-12 Total Score: Change from Baseline	See outcome measure #1.	Baseline to week 5, 17, 23, and 29	No
Secondary	TBF-12 Factorial Scores: Change from Baseline	See outcome measure #1.	Baseline to week 5, 17, 23, and 29	No
Secondary	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	No
Secondary	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	No
Secondary	Tinnitus Severity Scale (one week version): Change from Baseline	See outcome measure #2.	Baseline to week 5, 17, 23, and 29	No
Secondary	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	No
Secondary	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	No
Secondary	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	No