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

Primary Purpose

Subjective Tinnitus

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Neramexane mesylate
Placebo
Sponsored by
Merz Pharmaceuticals GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Subjective Tinnitus focused on measuring Subjective, Tinnitus

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Horizon Clinical Research Associates PLLC
  • Phoenix Clinical
  • Paradigm Clinical Research
  • Providence Clinical Research
  • Central California Clinical Research
  • UC Davis Health System
  • Colorado Otolaryngology Associates
  • New West Physicians
  • Visions Clinical Research
  • Tampa Bay Medical Research
  • Clinical Research of West Florida, Inc.
  • Deerpath Physicians Group
  • Knight Center for Integrated Health
  • Deaconess Clinic, Inc.
  • MediSphere Medical Research Center, LLC
  • Deaconess Clinic, Inc.
  • University of Iowa Hospitals & Clinics
  • University of Kansas; Department of Otolaryngology Head & Neck Surgery
  • Heartland Research Associates, LLC.
  • Heartland Research Associates, LLC.
  • Commonwealth Ear, Nose & Throat
  • Glacier Ear, Nose, and Throat, Head and Neck Surgery, P.C.
  • Immedicenter
  • David L. Bortniker
  • Montefiore Medical Center
  • Erie County Medical Center, Department of Rehabilitation Medicine; State University of New York at Buffalo
  • Cary Medical Research
  • Wake Research Associates, LLC
  • Wilmington Medical Research
  • Piedmont Medical Research
  • Medical University of South Carlolina, Otolaryngology
  • Austin Ear, Nose and Throat Clinic
  • Future Search Trials of Neurology
  • FutureSearch Trials of Dallas
  • R/D Clinical Research, Inc.
  • South Texas Research Alliance LLC
  • Research Across America
  • Advanced Clinical Research
  • Health Research of Hampton Roads, Inc.
  • Krankenhaus der Elisabethinen
  • Bezirkskrankenhaus Kufstein
  • A. ö. Krankenhaus der Elisabethinen Linz
  • Clin Pharm International GmbH, Zentrum Wien
  • Consultório Dr. Marcelo Rates
  • Instituto de Otorrinolaringologia Linhares
  • Hospital de Clinicas de Porto Alegre
  • Faculdade de Medicina do ABC
  • Universidade Federal de São Paulo - UNIFESP
  • Instituto Ganz Sanchez
  • Clínica OTOSUL
  • Klin. Forschung Berlin Buch GmbH
  • Praxis im Schlosscarree
  • Dr. Klaus Peter Jayme
  • Dr. Christian Dörr
  • Dr. Elisabeth Kühne
  • Dr. Werner Gieselmann
  • Dr. Wolfgang Lotte
  • ClinPharm International GmbH
  • HNO Praxis, Bamberger Str. 7
  • Dr. Dannesberger
  • LMU München, Klinikum Großhadern
  • Dr. Susanne Wiedemann
  • Instituto Biomédico de Investigación A.C.
  • Hospital General de Chihuahua
  • Hospital Christus Muguerza del Parque
  • Clinical Research Instutute S.C.
  • Hospital Civil de Guadalajara "Fray Antonio Alcalde", Servicio de Otorrinolaringología; Hospital No. 278
  • Grupo Médico Terranova
  • Unidad de Investigación Clínica Cardiometábolica de Occidente S.C. (UNICAMO)
  • Hospital General de México S.S. O.D.; Servicio de Otorrinolaringología
  • Hospital OCA Monterrey International Research Center (MIRC)
  • Hospital Universitario
  • Unidad de Tratamientos Avanzados (UTRAV) S.C.
  • Hospital Central "Dr. Ignacio Morones Prieto"; Servicio de Otorrinolaringología
  • Medicentro del Parque
  • Unidad Médica de Especialidades del Noroeste (UMEN)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Neramexane mesylate

Placebo

Arm Description

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

Placebo: identical placebo tablets

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

TBF-12 Total Score: Change from Baseline
See outcome measure #1.
TBF-12 Factorial Scores: Change from Baseline
See outcome measure #1.
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.
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.
Tinnitus Severity Scale (one week version): Change from Baseline
See outcome measure #2.
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".
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.
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".

Full Information

First Posted
August 6, 2009
Last Updated
November 27, 2012
Sponsor
Merz Pharmaceuticals GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT00955799
Brief Title
Efficacy, Safety, Tolerability of Neramexane in Patients With Subjective Tinnitus
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Clinical Evaluation of the Efficacy, Safety and Tolerability of Neramexane in Patients With Subjective Tinnitus
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merz Pharmaceuticals GmbH

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subjective Tinnitus
Keywords
Subjective, Tinnitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
455 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Neramexane mesylate
Arm Type
Experimental
Arm Description
Double-blind treatment period of 29 weeks up to 75 mg Neramexane mesylate per day
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo: identical placebo tablets
Intervention Type
Drug
Intervention Name(s)
Neramexane mesylate
Intervention Description
Double-blind treatment period of 29 weeks up to 75 mg Neramexane mesylate per day
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Double-blind treatment period of 29 weeks placebo
Primary Outcome Measure Information:
Title
Absolute Change in TBF-12 (Tinnitus Handicap Inventory-12) Total Score from Baseline.
Description
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.
Time Frame
Baseline to week 17 and 29
Title
Absolute Change in TSSw (Tinnitus Severity Scale - One Week Version) Total Score from Baseline.
Description
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.
Time Frame
Baseline to week 17 and 29
Secondary Outcome Measure Information:
Title
TBF-12 Total Score: Change from Baseline
Description
See outcome measure #1.
Time Frame
Baseline to week 5, 17, 23, and 29
Title
TBF-12 Factorial Scores: Change from Baseline
Description
See outcome measure #1.
Time Frame
Baseline to week 5, 17, 23, and 29
Title
TBF-12: Individual Responder Rate
Description
See outcome measure #1. A subject is considered responder if TBF-12 decreases at least 4 score points between baseline and respective visit.
Time Frame
Week 5, 17, 23, and 29
Title
Tinnitus Rating Scale (one week version): Change from Baseline
Description
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.
Time Frame
Baseline to week 5, 17, 23, and 29
Title
Tinnitus Severity Scale (one week version): Change from Baseline
Description
See outcome measure #2.
Time Frame
Baseline to week 5, 17, 23, and 29
Title
Attention and Performance Self-Assessment (ASPA) Questionnaire: Change from Baseline
Description
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".
Time Frame
Baseline to week 5, 17, 23, and 29
Title
Quality of Life Questionnaire (SF-36™ Health Survey): Change from Baseline
Description
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.
Time Frame
Baseline to week 17 and 29
Title
Hospital Anxiety and Depression Scale (HADS): Change from Baseline
Description
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".
Time Frame
Baseline to week 17 and 29

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Expert
Organizational Affiliation
Merz Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Horizon Clinical Research Associates PLLC
City
Gilbert
State/Province
Arizona
ZIP/Postal Code
85295
Country
United States
Facility Name
Phoenix Clinical
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85015
Country
United States
Facility Name
Paradigm Clinical Research
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85705
Country
United States
Facility Name
Providence Clinical Research
City
Burbank
State/Province
California
ZIP/Postal Code
91505
Country
United States
Facility Name
Central California Clinical Research
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
UC Davis Health System
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Colorado Otolaryngology Associates
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80909
Country
United States
Facility Name
New West Physicians
City
Golden
State/Province
Colorado
ZIP/Postal Code
80401
Country
United States
Facility Name
Visions Clinical Research
City
Boynton Beach,
State/Province
Florida
ZIP/Postal Code
33472
Country
United States
Facility Name
Tampa Bay Medical Research
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33761
Country
United States
Facility Name
Clinical Research of West Florida, Inc.
City
Tampa
State/Province
Florida
ZIP/Postal Code
33603
Country
United States
Facility Name
Deerpath Physicians Group
City
Gurnee
State/Province
Illinois
ZIP/Postal Code
60031
Country
United States
Facility Name
Knight Center for Integrated Health
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61614
Country
United States
Facility Name
Deaconess Clinic, Inc.
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47710
Country
United States
Facility Name
MediSphere Medical Research Center, LLC
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Facility Name
Deaconess Clinic, Inc.
City
Newburgh
State/Province
Indiana
ZIP/Postal Code
47630
Country
United States
Facility Name
University of Iowa Hospitals & Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242-1078
Country
United States
Facility Name
University of Kansas; Department of Otolaryngology Head & Neck Surgery
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160-0001
Country
United States
Facility Name
Heartland Research Associates, LLC.
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67205
Country
United States
Facility Name
Heartland Research Associates, LLC.
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67207
Country
United States
Facility Name
Commonwealth Ear, Nose & Throat
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Facility Name
Glacier Ear, Nose, and Throat, Head and Neck Surgery, P.C.
City
Kalispell
State/Province
Montana
ZIP/Postal Code
59901
Country
United States
Facility Name
Immedicenter
City
Bloomfield
State/Province
New Jersey
ZIP/Postal Code
07003
Country
United States
Facility Name
David L. Bortniker
City
Somerville
State/Province
New Jersey
ZIP/Postal Code
08876
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10867
Country
United States
Facility Name
Erie County Medical Center, Department of Rehabilitation Medicine; State University of New York at Buffalo
City
Buffalo
State/Province
New York
ZIP/Postal Code
14221
Country
United States
Facility Name
Cary Medical Research
City
Cary
State/Province
North Carolina
ZIP/Postal Code
27518
Country
United States
Facility Name
Wake Research Associates, LLC
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Wilmington Medical Research
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Piedmont Medical Research
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Medical University of South Carlolina, Otolaryngology
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Austin Ear, Nose and Throat Clinic
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Future Search Trials of Neurology
City
Austin
State/Province
Texas
ZIP/Postal Code
78756
Country
United States
Facility Name
FutureSearch Trials of Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
R/D Clinical Research, Inc.
City
Lake Jackson
State/Province
Texas
ZIP/Postal Code
77566
Country
United States
Facility Name
South Texas Research Alliance LLC
City
Laredo
State/Province
Texas
ZIP/Postal Code
78041
Country
United States
Facility Name
Research Across America
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
Advanced Clinical Research
City
West Jordon
State/Province
Utah
ZIP/Postal Code
84088
Country
United States
Facility Name
Health Research of Hampton Roads, Inc.
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23606
Country
United States
Facility Name
Krankenhaus der Elisabethinen
City
Graz
ZIP/Postal Code
8020
Country
Austria
Facility Name
Bezirkskrankenhaus Kufstein
City
Kufstein
ZIP/Postal Code
6330
Country
Austria
Facility Name
A. ö. Krankenhaus der Elisabethinen Linz
City
Linz
ZIP/Postal Code
4010
Country
Austria
Facility Name
Clin Pharm International GmbH, Zentrum Wien
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Consultório Dr. Marcelo Rates
City
Bello Horizonte
ZIP/Postal Code
30150-270
Country
Brazil
Facility Name
Instituto de Otorrinolaringologia Linhares
City
Rio de Janeiro
Country
Brazil
Facility Name
Hospital de Clinicas de Porto Alegre
City
Rio Grande do Sul
ZIP/Postal Code
90035-001
Country
Brazil
Facility Name
Faculdade de Medicina do ABC
City
Santo André/SP
Country
Brazil
Facility Name
Universidade Federal de São Paulo - UNIFESP
City
Sao Paulo/ SP
Country
Brazil
Facility Name
Instituto Ganz Sanchez
City
São Paulo/SP
ZIP/Postal Code
05469-000
Country
Brazil
Facility Name
Clínica OTOSUL
City
Valenca
Country
Brazil
Facility Name
Klin. Forschung Berlin Buch GmbH
City
Berlin
ZIP/Postal Code
13125
Country
Germany
Facility Name
Praxis im Schlosscarree
City
Braunschweig
ZIP/Postal Code
38100
Country
Germany
Facility Name
Dr. Klaus Peter Jayme
City
Darmstadt
ZIP/Postal Code
64283
Country
Germany
Facility Name
Dr. Christian Dörr
City
Dresden
ZIP/Postal Code
01277
Country
Germany
Facility Name
Dr. Elisabeth Kühne
City
Halle/ Saale
ZIP/Postal Code
06112
Country
Germany
Facility Name
Dr. Werner Gieselmann
City
Heiligenhaus
ZIP/Postal Code
42579
Country
Germany
Facility Name
Dr. Wolfgang Lotte
City
Iserlohn
ZIP/Postal Code
58642
Country
Germany
Facility Name
ClinPharm International GmbH
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
HNO Praxis, Bamberger Str. 7
City
Lichtenfels
ZIP/Postal Code
96215
Country
Germany
Facility Name
Dr. Dannesberger
City
Lorsch
ZIP/Postal Code
64653
Country
Germany
Facility Name
LMU München, Klinikum Großhadern
City
München
ZIP/Postal Code
81377
Country
Germany
Facility Name
Dr. Susanne Wiedemann
City
Nürnberg
ZIP/Postal Code
90443
Country
Germany
Facility Name
Instituto Biomédico de Investigación A.C.
City
Aguascalientes
ZIP/Postal Code
CP 20127
Country
Mexico
Facility Name
Hospital General de Chihuahua
City
Chihuahua
ZIP/Postal Code
C.P. 31000
Country
Mexico
Facility Name
Hospital Christus Muguerza del Parque
City
Chihuahua
ZIP/Postal Code
CP 3100
Country
Mexico
Facility Name
Clinical Research Instutute S.C.
City
Edo. de México
ZIP/Postal Code
CP 54055
Country
Mexico
Facility Name
Hospital Civil de Guadalajara "Fray Antonio Alcalde", Servicio de Otorrinolaringología; Hospital No. 278
City
Guadalajara Jalisco
ZIP/Postal Code
CP 44280
Country
Mexico
Facility Name
Grupo Médico Terranova
City
Guadalajara Jalisco
ZIP/Postal Code
CP 44630
Country
Mexico
Facility Name
Unidad de Investigación Clínica Cardiometábolica de Occidente S.C. (UNICAMO)
City
Jalisco
ZIP/Postal Code
44150
Country
Mexico
Facility Name
Hospital General de México S.S. O.D.; Servicio de Otorrinolaringología
City
México D.F.
ZIP/Postal Code
06726
Country
Mexico
Facility Name
Hospital OCA Monterrey International Research Center (MIRC)
City
Nuevo León
ZIP/Postal Code
CP 64000
Country
Mexico
Facility Name
Hospital Universitario
City
Nuevo León
ZIP/Postal Code
CP 64400
Country
Mexico
Facility Name
Unidad de Tratamientos Avanzados (UTRAV) S.C.
City
Nuevo León
ZIP/Postal Code
CP64240
Country
Mexico
Facility Name
Hospital Central "Dr. Ignacio Morones Prieto"; Servicio de Otorrinolaringología
City
San Luis Potosí
ZIP/Postal Code
78240
Country
Mexico
Facility Name
Medicentro del Parque
City
San Luis Potosí
ZIP/Postal Code
C.P. 78269
Country
Mexico
Facility Name
Unidad Médica de Especialidades del Noroeste (UMEN)
City
Sinaloa
ZIP/Postal Code
80000
Country
Mexico

12. IPD Sharing Statement

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

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