Efficacy, Safety and Tolerability of Neramexane in Patients With Subjective Tinnitus (EASE)

This study has been completed.
Sponsor:
Information provided by:
Merz Pharmaceuticals GmbH
ClinicalTrials.gov Identifier:
NCT00739635
First received: August 21, 2008
Last updated: March 25, 2010
Last verified: March 2010
  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:


Further study details as provided by Merz Pharmaceuticals GmbH:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • TBF-12 factorial scores, individual responder rate, Tinnitus Rating Scale, Sleep Questionnaire, population pharmacokinetics, optional pharmacogenetics [ Time Frame: 17 weeks ] [ Designated as safety issue: No ]
  • safety parameters [ Time Frame: 17 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 400
Study Start Date: September 2008
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Neramexane mesylate
Double-blind treatment period of 17 weeks up to 75 mg Neramexane mesylate per day
Placebo Comparator: 2 Drug: Placebo
Double-blind treatment period of 17 weeks placebo

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  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: NCT00739635

  Hide Study Locations
Locations
Austria
Krankenhaus der Elisabethinen
Graz, Austria, A-8020
Bezirkskrankenhaus Kufstein
Kufstein, Austria, A-6330
A. ö. Krankenhaus der Elisabethinen Linz
Linz, Austria, A-4010
Salzburger Landeskrankenhaus, Universitätsklinik für Hals-Nasen-Ohren-Krankheiten
Salzburg, Austria, A-5020
Clin Pharm International GmbH, Zentrum Wien
Vienna, Austria, A-1090
Germany
Dr. Elisabeth Kühne
Halle, Saale, Germany, 06112
Dr. med. Nobert Pasch
Aachen, Germany, 52074
Dr. Peter Küppers
Augsburg, Germany, 86199
Charité, Universitätsmedizin Berlin-Tinnituszentrum
Berlin, Germany, 10117
Klin. Forschung Berlin Buch GmbH
Berlin, Germany, 13125
Dr. med. Frank Reintjes
Braunschweig, Germany, 38100
ClinPharm International
Chemnitz, Germany, 09120
Dr. Klaus Peter Jayme
Darmstadt, Germany, 64283
Dr. Christian Dörr
Dresden, Germany, 01277
HNO-Praxis im Gesundheitszentrum Walsum
Duisburg, Germany, 47179
ClinPharm International GmbH
Frankfurt, Germany, 60596
ClinPharm International GmbH
Görlitz, Germany, 02826
Dr. Werner Gieselmann
Heiligenhaus, Germany, 42579
Dr. Wolfgang Lotte
Iserlohn, Germany, 58642
ClinPharm International GmbH
Leipzig, Germany, 04103
HNO Praxis
Lichtenfels, Germany, 96215
Dr. Dannesberger
Lorsch, Germany, 64653
ClinPharm International
Magdeburg, Germany, 39104
HNO Gemeinschaftpraxis
Meppen, Germany, 48716
LMU München Klinik Großhadern
Munich, Germany
Dr. med. Ulrike Walter
Nürnberg, Germany, 90402
Dr. Susanne Wiedemann
Nürnberg, Germany, 90443
Dr. Norbert Staab
Schlüchtern, Germany, 36381
Dr. Hannelore Neumaier
Wiesbaden, Germany, 65183
Dr. med. Stephanie Göbel
Worms, Germany, 67547
Portugal
Hospital Militar Regional nº 1 Serviço de Otorrinolaringologia
Porto, Portugal, 4050-113
Clínica ORL Dr. Eurico de Almeida
Porto, Portugal, 4050-115
Spain
Clínica Universitaria de Navarra, Dept. ORL
Pamplona, Navarra, Spain, 31008
Hospital Sagunto
Sagunto, Valencia, Spain, 46520
Fundación Hospital de Alcorcón, Otorhinolaryngology
Alcorcón - Madrid, Spain, 28922
Hospital Clínico Barcelona, Dept. Of ORL
Barcelona, Spain, 08036
Clinica Clivina, Private Consultancy
Jaén, Spain
Hospital Comarcal San Agustin
Linares, Jaén, Spain, 23700
Hospital Xeral-Calde
Lugo, Spain
Hospital Puerta del Hierro, Madrid- Servicio de OR
Madrid, Spain, 28035
Hospital Universitario Príncipe de Asturias
Madrid, Spain, 28805
Hospital Universtiario Son Dureta
Palma de Mallorca, Spain, 07004
Hospital Universitario de Salamanca- Hospital Virgen de la Vega
Salamanca, Spain, 37007
Hospital Universitario Virgen del Rocio- Centro de Especialidades Dr. Fleming
Sevilla, Spain, 41005
United Kingdom
Oldfield Surgery
Bath, United Kingdom, BA2 3HT
Avondale Surgery Research office
Chesterfield, United Kingdom, S40 4TF
The Horsley Medical Practice
East Horsley, Leatherhead, Surrey, United Kingdom, KT24 6QT
The university Hospitals of Leicester, Leicester Royal Infirmary
Leicester, United Kingdom, LE1 5WW
Burbage Surgery
Leicestershire, United Kingdom, LE10 2SE
The Freeman Hospital
Newcastle upon Tyne, United Kingdom, NE7 7DN
Wansford and Kings Cliffe Practice
Petereborough, United Kingdom, PE8 6PL
Frome Medical Practice
Somerset, United Kingdom, BA11 1EZ
Dr. Trevor Gooding
Warwick Shire, United Kingdom, CV9 1EU
Sherbourne Medical Centre
Warwickshire, United Kingdom, CV32 4RA
Sponsors and Collaborators
Merz Pharmaceuticals GmbH
  More Information

Additional Information:
No publications provided

Responsible Party: Irena Pulte, MD, Clinical R & D CNS
ClinicalTrials.gov Identifier: NCT00739635     History of Changes
Other Study ID Numbers: MRZ 92579/TI/3001, EudraCT Number 2007-007835-16
Study First Received: August 21, 2008
Last Updated: March 25, 2010
Health Authority: Austria: AGES PharmMed Bundesamt für Sicherheit im Gesundheitswesen
Germany: Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM)Fachregistratur Z 172
Portugal: INFARMED Autoridade Nacional do Medicamento e Produtos de Saúde, I.P.
Spain: Agencia Española de Medicamentos y Productos Sanitarios (AEMPS)
UK: MHRA The Clinical Trials Unit, Department of Health

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 October 19, 2014