Efficacy, Safety and Tolerability of Neramexane in Patients With Subjective Tinnitus (EASE)
This study has been completed.
Sponsor:
Merz Pharmaceuticals GmbH
Information provided by:
Merz Pharmaceuticals GmbH
ClinicalTrials.gov Identifier:
NCT00739635
First received: August 21, 2008
Last updated: March 25, 2010
Last verified: March 2010
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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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00739635
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| 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 | |
| Klin. Forschung Berlin Buch GmbH | |
| Berlin, Germany, 13125 | |
| Charité, Universitätsmedizin Berlin-Tinnituszentrum | |
| Berlin, Germany, 10117 | |
| 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 May 19, 2013