Efficacy, Safety and Tolerability of Neramexane in Patients With Subjective Tinnitus
EASE
A Randomized, Double-Blind, Placebo-Controlled, Clinical Evaluation of the Efficacy, Safety and Tolerability of Neramexane in Patients With Subjective Tinnitus
2 other identifiers
interventional
411
5 countries
54
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Sep 2008
54 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 21, 2008
CompletedFirst Posted
Study publicly available on registry
August 22, 2008
CompletedStudy Start
First participant enrolled
September 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2010
CompletedFebruary 4, 2016
February 1, 2016
1.4 years
August 21, 2008
February 3, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
TBF-12 (Tinnitus-Beeinträchtigungs-Fragebogen-12 "Tinnitus Handicap Inventory-12") total score change from baseline to end of treatment
Screening, Baseline, week 5, 13, 17
Secondary Outcomes (2)
TBF-12 factorial scores, individual responder rate, Tinnitus Rating Scale, Sleep Questionnaire, population pharmacokinetics, optional pharmacogenetics
17 weeks
safety parameters
17 weeks
Study Arms (2)
1
EXPERIMENTAL2
PLACEBO COMPARATORInterventions
Double-blind treatment period of 17 weeks up to 75 mg Neramexane mesylate per day
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (54)
Krankenhaus der Elisabethinen
Graz, A-8020, Austria
Bezirkskrankenhaus Kufstein
Kufstein, A-6330, Austria
A. ö. Krankenhaus der Elisabethinen Linz
Linz, A-4010, Austria
Salzburger Landeskrankenhaus, Universitätsklinik für Hals-Nasen-Ohren-Krankheiten
Salzburg, A-5020, Austria
Clin Pharm International GmbH, Zentrum Wien
Vienna, A-1090, Austria
Dr. Elisabeth Kühne
Halle, Saale, 06112, Germany
Dr. med. Nobert Pasch
Aachen, 52074, Germany
Dr. Peter Küppers
Augsburg, 86199, Germany
Charité, Universitätsmedizin Berlin-Tinnituszentrum
Berlin, 10117, Germany
Klin. Forschung Berlin Buch GmbH
Berlin, 13125, Germany
Dr. med. Frank Reintjes
Braunschweig, 38100, Germany
ClinPharm International
Chemnitz, 09120, Germany
Dr. Klaus Peter Jayme
Darmstadt, 64283, Germany
Dr. Christian Dörr
Dresden, 01277, Germany
HNO-Praxis im Gesundheitszentrum Walsum
Duisburg, 47179, Germany
ClinPharm International GmbH
Frankfurt, 60596, Germany
ClinPharm International GmbH
Görlitz, 02826, Germany
Dr. Werner Gieselmann
Heiligenhaus, 42579, Germany
Dr. Wolfgang Lotte
Iserlohn, 58642, Germany
ClinPharm International GmbH
Leipzig, 04103, Germany
HNO Praxis
Lichtenfels, 96215, Germany
Dr. Dannesberger
Lorsch, 64653, Germany
ClinPharm International
Magdeburg, 39104, Germany
HNO Gemeinschaftpraxis
Meppen, 48716, Germany
LMU München Klinik Großhadern
Munich, Germany
Dr. med. Ulrike Walter
Nuremberg, 90402, Germany
Dr. Susanne Wiedemann
Nuremberg, 90443, Germany
Dr. Norbert Staab
Schlüchtern, 36381, Germany
Dr. Hannelore Neumaier
Wiesbaden, 65183, Germany
Dr. med. Stephanie Göbel
Worms, 67547, Germany
Hospital Militar Regional nº 1 Serviço de Otorrinolaringologia
Porto, 4050-113, Portugal
Clínica ORL Dr. Eurico de Almeida
Porto, 4050-115, Portugal
Clínica Universitaria de Navarra, Dept. ORL
Pamplona, Navarre, 31008, Spain
Hospital Sagunto
Sagunto, Valencia, 46520, Spain
Fundación Hospital de Alcorcón, Otorhinolaryngology
Alcorcón - Madrid, 28922, Spain
Hospital Clínico Barcelona, Dept. Of ORL
Barcelona, 08036, Spain
Clinica Clivina, Private Consultancy
Jaén, Spain
Hospital Comarcal San Agustin
Linares, Jaén, 23700, Spain
Hospital Xeral-Calde
Lugo, Spain
Hospital Puerta del Hierro, Madrid- Servicio de OR
Madrid, 28035, Spain
Hospital Universitario Príncipe de Asturias
Madrid, 28805, Spain
Hospital Universtiario Son Dureta
Palma de Mallorca, 07004, Spain
Hospital Universitario de Salamanca- Hospital Virgen de la Vega
Salamanca, 37007, Spain
Hospital Universitario Virgen del Rocio- Centro de Especialidades Dr. Fleming
Seville, 41005, Spain
Oldfield Surgery
Bath, BA2 3HT, United Kingdom
Avondale Surgery Research office
Chesterfield, S40 4TF, United Kingdom
The Horsley Medical Practice
East Horsley, Leatherhead, Surrey, KT24 6QT, United Kingdom
The university Hospitals of Leicester, Leicester Royal Infirmary
Leicester, LE1 5WW, United Kingdom
Burbage Surgery
Leicestershire, LE10 2SE, United Kingdom
The Freeman Hospital
Newcastle upon Tyne, NE7 7DN, United Kingdom
Wansford and Kings Cliffe Practice
Petereborough, PE8 6PL, United Kingdom
Frome Medical Practice
Somerset, BA11 1EZ, United Kingdom
Dr. Trevor Gooding
Warwick Shire, CV9 1EU, United Kingdom
Sherbourne Medical Centre
Warwickshire, CV32 4RA, United Kingdom
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 21, 2008
First Posted
August 22, 2008
Study Start
September 1, 2008
Primary Completion
February 1, 2010
Study Completion
February 1, 2010
Last Updated
February 4, 2016
Record last verified: 2016-02