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

Subjective Tinnitus Clinical Trial

— EASE  

Official title:

A Randomized, Double-Blind, Placebo-Controlled, Clinical Evaluation of the Efficacy, Safety and Tolerability of Neramexane in Patients With Subjective Tinnitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00739635
• Other study ID #: MRZ 92579/TI/3001
• Secondary ID: EudraCT Number 2
• Status: Completed
• Phase: Phase 3
• First received: August 21, 2008
• Last updated: February 3, 2016
• Start date: September 2008
• Est. completion date: February 2010

Study information

• Verified date: February 2016
• Source: Merz Pharmaceuticals GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: AGES PharmMed Bundesamt für Sicherheit im GesundheitswesenGermany: Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM)Fachregistratur Z 172Portugal: 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
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 411
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Subjective Tinnitus
• Tinnitus

Intervention

Drug:
• Neramexane mesylate
Double-blind treatment period of 17 weeks up to 75 mg Neramexane mesylate per day
• Placebo
Double-blind treatment period of 17 weeks placebo

Locations

Country	Name	City	State
Austria	Krankenhaus der Elisabethinen	Graz
Austria	Bezirkskrankenhaus Kufstein	Kufstein
Austria	A. ö. Krankenhaus der Elisabethinen Linz	Linz
Austria	Salzburger Landeskrankenhaus, Universitätsklinik für Hals-Nasen-Ohren-Krankheiten	Salzburg
Austria	Clin Pharm International GmbH, Zentrum Wien	Vienna
Germany	Dr. med. Nobert Pasch	Aachen
Germany	Dr. Peter Küppers	Augsburg
Germany	Charité, Universitätsmedizin Berlin-Tinnituszentrum	Berlin
Germany	Klin. Forschung Berlin Buch GmbH	Berlin
Germany	Dr. med. Frank Reintjes	Braunschweig
Germany	ClinPharm International	Chemnitz
Germany	Dr. Klaus Peter Jayme	Darmstadt
Germany	Dr. Christian Dörr	Dresden
Germany	HNO-Praxis im Gesundheitszentrum Walsum	Duisburg
Germany	ClinPharm International GmbH	Frankfurt
Germany	ClinPharm International GmbH	Görlitz
Germany	Dr. Elisabeth Kühne	Halle	Saale
Germany	Dr. Werner Gieselmann	Heiligenhaus
Germany	Dr. Wolfgang Lotte	Iserlohn
Germany	ClinPharm International GmbH	Leipzig
Germany	HNO Praxis	Lichtenfels
Germany	Dr. Dannesberger	Lorsch
Germany	ClinPharm International	Magdeburg
Germany	HNO Gemeinschaftpraxis	Meppen
Germany	LMU München Klinik Großhadern	Munich
Germany	Dr. med. Ulrike Walter	Nürnberg
Germany	Dr. Susanne Wiedemann	Nürnberg
Germany	Dr. Norbert Staab	Schlüchtern
Germany	Dr. Hannelore Neumaier	Wiesbaden
Germany	Dr. med. Stephanie Göbel	Worms
Portugal	Clínica ORL Dr. Eurico de Almeida	Porto
Portugal	Hospital Militar Regional nº 1 Serviço de Otorrinolaringologia	Porto
Spain	Fundación Hospital de Alcorcón, Otorhinolaryngology	Alcorcón - Madrid
Spain	Hospital Clínico Barcelona, Dept. Of ORL	Barcelona
Spain	Clinica Clivina, Private Consultancy	Jaén
Spain	Hospital Comarcal San Agustin	Linares, Jaén
Spain	Hospital Xeral-Calde	Lugo
Spain	Hospital Puerta del Hierro, Madrid- Servicio de OR	Madrid
Spain	Hospital Universitario Príncipe de Asturias	Madrid
Spain	Hospital Universtiario Son Dureta	Palma de Mallorca
Spain	Clínica Universitaria de Navarra, Dept. ORL	Pamplona	Navarra
Spain	Hospital Sagunto	Sagunto	Valencia
Spain	Hospital Universitario de Salamanca- Hospital Virgen de la Vega	Salamanca
Spain	Hospital Universitario Virgen del Rocio- Centro de Especialidades Dr. Fleming	Sevilla
United Kingdom	Oldfield Surgery	Bath
United Kingdom	Avondale Surgery Research office	Chesterfield
United Kingdom	The Horsley Medical Practice	East Horsley, Leatherhead, Surrey
United Kingdom	The university Hospitals of Leicester, Leicester Royal Infirmary	Leicester
United Kingdom	Burbage Surgery	Leicestershire
United Kingdom	The Freeman Hospital	Newcastle upon Tyne
United Kingdom	Wansford and Kings Cliffe Practice	Petereborough
United Kingdom	Frome Medical Practice	Somerset
United Kingdom	Dr. Trevor Gooding	Warwick Shire
United Kingdom	Sherbourne Medical Centre	Warwickshire

Sponsors (1)

Lead Sponsor	Collaborator
Merz Pharmaceuticals GmbH

Countries where clinical trial is conducted

Austria,  Germany,  Portugal,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	TBF-12 factorial scores, individual responder rate, Tinnitus Rating Scale, Sleep Questionnaire, population pharmacokinetics, optional pharmacogenetics		17 weeks	No
Secondary	safety parameters		17 weeks	Yes

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