Back to resultsEfficacy, Safety and Tolerability of Neramexane in Patients With Subjective Tinnitus (EASE)
Primary Purpose
Subjective Tinnitus
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Neramexane mesylate
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Subjective Tinnitus
Eligibility Criteria
Inclusion Criteria:
- Patients aged 18 to 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 tinnitus present for at least 3 months but not more than 12 months
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
- Krankenhaus der Elisabethinen
- Bezirkskrankenhaus Kufstein
- A. ö. Krankenhaus der Elisabethinen Linz
- Salzburger Landeskrankenhaus, Universitätsklinik für Hals-Nasen-Ohren-Krankheiten
- Clin Pharm International GmbH, Zentrum Wien
- Dr. Elisabeth Kühne
- Dr. med. Nobert Pasch
- Dr. Peter Küppers
- Charité, Universitätsmedizin Berlin-Tinnituszentrum
- Klin. Forschung Berlin Buch GmbH
- Dr. med. Frank Reintjes
- ClinPharm International
- Dr. Klaus Peter Jayme
- Dr. Christian Dörr
- HNO-Praxis im Gesundheitszentrum Walsum
- ClinPharm International GmbH
- ClinPharm International GmbH
- Dr. Werner Gieselmann
- Dr. Wolfgang Lotte
- ClinPharm International GmbH
- HNO Praxis
- Dr. Dannesberger
- ClinPharm International
- HNO Gemeinschaftpraxis
- LMU München Klinik Großhadern
- Dr. med. Ulrike Walter
- Dr. Susanne Wiedemann
- Dr. Norbert Staab
- Dr. Hannelore Neumaier
- Dr. med. Stephanie Göbel
- Hospital Militar Regional nº 1 Serviço de Otorrinolaringologia
- Clínica ORL Dr. Eurico de Almeida
- Clínica Universitaria de Navarra, Dept. ORL
- Hospital Sagunto
- Fundación Hospital de Alcorcón, Otorhinolaryngology
- Hospital Clínico Barcelona, Dept. Of ORL
- Clinica Clivina, Private Consultancy
- Hospital Comarcal San Agustin
- Hospital Xeral-Calde
- Hospital Puerta del Hierro, Madrid- Servicio de OR
- Hospital Universitario Príncipe de Asturias
- Hospital Universtiario Son Dureta
- Hospital Universitario de Salamanca- Hospital Virgen de la Vega
- Hospital Universitario Virgen del Rocio- Centro de Especialidades Dr. Fleming
- Oldfield Surgery
- Avondale Surgery Research office
- The Horsley Medical Practice
- Burbage Surgery
- The university Hospitals of Leicester, Leicester Royal Infirmary
- The Freeman Hospital
- Wansford and Kings Cliffe Practice
- Frome Medical Practice
- Dr. Trevor Gooding
- Sherbourne Medical Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
TBF-12 (Tinnitus-Beeinträchtigungs-Fragebogen-12 "Tinnitus Handicap Inventory-12") total score change from baseline to end of treatment
Secondary Outcome Measures
TBF-12 factorial scores, individual responder rate, Tinnitus Rating Scale, Sleep Questionnaire, population pharmacokinetics, optional pharmacogenetics
safety parameters
Full Information
NCT ID
NCT00739635
First Posted
August 21, 2008
Last Updated
February 3, 2016
Sponsor
Merz Pharmaceuticals GmbH
1. Study Identification
Unique Protocol Identification Number
NCT00739635
Brief Title
Efficacy, Safety and Tolerability of Neramexane in Patients With Subjective Tinnitus
Acronym
EASE
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
February 2016
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
February 2010 (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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
411 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Neramexane mesylate
Intervention Description
Double-blind treatment period of 17 weeks up to 75 mg Neramexane mesylate per day
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Double-blind treatment period of 17 weeks placebo
Primary Outcome Measure Information:
Title
TBF-12 (Tinnitus-Beeinträchtigungs-Fragebogen-12 "Tinnitus Handicap Inventory-12") total score change from baseline to end of treatment
Time Frame
Screening, Baseline, week 5, 13, 17
Secondary Outcome Measure Information:
Title
TBF-12 factorial scores, individual responder rate, Tinnitus Rating Scale, Sleep Questionnaire, population pharmacokinetics, optional pharmacogenetics
Time Frame
17 weeks
Title
safety parameters
Time Frame
17 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients aged 18 to 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 tinnitus present for at least 3 months but not more than 12 months
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)
Facility Information:
Facility Name
Krankenhaus der Elisabethinen
City
Graz
ZIP/Postal Code
A-8020
Country
Austria
Facility Name
Bezirkskrankenhaus Kufstein
City
Kufstein
ZIP/Postal Code
A-6330
Country
Austria
Facility Name
A. ö. Krankenhaus der Elisabethinen Linz
City
Linz
ZIP/Postal Code
A-4010
Country
Austria
Facility Name
Salzburger Landeskrankenhaus, Universitätsklinik für Hals-Nasen-Ohren-Krankheiten
City
Salzburg
ZIP/Postal Code
A-5020
Country
Austria
Facility Name
Clin Pharm International GmbH, Zentrum Wien
City
Vienna
ZIP/Postal Code
A-1090
Country
Austria
Facility Name
Dr. Elisabeth Kühne
City
Halle
State/Province
Saale
ZIP/Postal Code
06112
Country
Germany
Facility Name
Dr. med. Nobert Pasch
City
Aachen
ZIP/Postal Code
52074
Country
Germany
Facility Name
Dr. Peter Küppers
City
Augsburg
ZIP/Postal Code
86199
Country
Germany
Facility Name
Charité, Universitätsmedizin Berlin-Tinnituszentrum
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Klin. Forschung Berlin Buch GmbH
City
Berlin
ZIP/Postal Code
13125
Country
Germany
Facility Name
Dr. med. Frank Reintjes
City
Braunschweig
ZIP/Postal Code
38100
Country
Germany
Facility Name
ClinPharm International
City
Chemnitz
ZIP/Postal Code
09120
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
HNO-Praxis im Gesundheitszentrum Walsum
City
Duisburg
ZIP/Postal Code
47179
Country
Germany
Facility Name
ClinPharm International GmbH
City
Frankfurt
ZIP/Postal Code
60596
Country
Germany
Facility Name
ClinPharm International GmbH
City
Görlitz
ZIP/Postal Code
02826
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
City
Lichtenfels
ZIP/Postal Code
96215
Country
Germany
Facility Name
Dr. Dannesberger
City
Lorsch
ZIP/Postal Code
64653
Country
Germany
Facility Name
ClinPharm International
City
Magdeburg
ZIP/Postal Code
39104
Country
Germany
Facility Name
HNO Gemeinschaftpraxis
City
Meppen
ZIP/Postal Code
48716
Country
Germany
Facility Name
LMU München Klinik Großhadern
City
Munich
Country
Germany
Facility Name
Dr. med. Ulrike Walter
City
Nürnberg
ZIP/Postal Code
90402
Country
Germany
Facility Name
Dr. Susanne Wiedemann
City
Nürnberg
ZIP/Postal Code
90443
Country
Germany
Facility Name
Dr. Norbert Staab
City
Schlüchtern
ZIP/Postal Code
36381
Country
Germany
Facility Name
Dr. Hannelore Neumaier
City
Wiesbaden
ZIP/Postal Code
65183
Country
Germany
Facility Name
Dr. med. Stephanie Göbel
City
Worms
ZIP/Postal Code
67547
Country
Germany
Facility Name
Hospital Militar Regional nº 1 Serviço de Otorrinolaringologia
City
Porto
ZIP/Postal Code
4050-113
Country
Portugal
Facility Name
Clínica ORL Dr. Eurico de Almeida
City
Porto
ZIP/Postal Code
4050-115
Country
Portugal
Facility Name
Clínica Universitaria de Navarra, Dept. ORL
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Facility Name
Hospital Sagunto
City
Sagunto
State/Province
Valencia
ZIP/Postal Code
46520
Country
Spain
Facility Name
Fundación Hospital de Alcorcón, Otorhinolaryngology
City
Alcorcón - Madrid
ZIP/Postal Code
28922
Country
Spain
Facility Name
Hospital Clínico Barcelona, Dept. Of ORL
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Clinica Clivina, Private Consultancy
City
Jaén
Country
Spain
Facility Name
Hospital Comarcal San Agustin
City
Linares, Jaén
ZIP/Postal Code
23700
Country
Spain
Facility Name
Hospital Xeral-Calde
City
Lugo
Country
Spain
Facility Name
Hospital Puerta del Hierro, Madrid- Servicio de OR
City
Madrid
ZIP/Postal Code
28035
Country
Spain
Facility Name
Hospital Universitario Príncipe de Asturias
City
Madrid
ZIP/Postal Code
28805
Country
Spain
Facility Name
Hospital Universtiario Son Dureta
City
Palma de Mallorca
ZIP/Postal Code
07004
Country
Spain
Facility Name
Hospital Universitario de Salamanca- Hospital Virgen de la Vega
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocio- Centro de Especialidades Dr. Fleming
City
Sevilla
ZIP/Postal Code
41005
Country
Spain
Facility Name
Oldfield Surgery
City
Bath
ZIP/Postal Code
BA2 3HT
Country
United Kingdom
Facility Name
Avondale Surgery Research office
City
Chesterfield
ZIP/Postal Code
S40 4TF
Country
United Kingdom
Facility Name
The Horsley Medical Practice
City
East Horsley, Leatherhead, Surrey
ZIP/Postal Code
KT24 6QT
Country
United Kingdom
Facility Name
Burbage Surgery
City
Leicestershire
ZIP/Postal Code
LE10 2SE
Country
United Kingdom
Facility Name
The university Hospitals of Leicester, Leicester Royal Infirmary
City
Leicester
ZIP/Postal Code
LE1 5WW
Country
United Kingdom
Facility Name
The Freeman Hospital
City
Newcastle upon Tyne
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
Facility Name
Wansford and Kings Cliffe Practice
City
Petereborough
ZIP/Postal Code
PE8 6PL
Country
United Kingdom
Facility Name
Frome Medical Practice
City
Somerset
ZIP/Postal Code
BA11 1EZ
Country
United Kingdom
Facility Name
Dr. Trevor Gooding
City
Warwick Shire
ZIP/Postal Code
CV9 1EU
Country
United Kingdom
Facility Name
Sherbourne Medical Centre
City
Warwickshire
ZIP/Postal Code
CV32 4RA
Country
United Kingdom
12. IPD Sharing Statement
Links:
URL
http://www.merz.com
Description
Related Info
Learn more about this trial
Efficacy, Safety and Tolerability of Neramexane in Patients With Subjective Tinnitus
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