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

Phase 3

Completed

• Conditions: Subjective Tinnitus
• Interventions: Drug: Neramexane mesylate; Drug: Placebo

• Registration Number: NCT00739635
• Lead Sponsor: Merz Pharmaceuticals GmbH

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-08-21
• Study First Submitted QC: 2008-08-21
• Study First Posted: 2008-08-22
• Study Start: 2008-09
• Primary Completion: 2010-02
• Study Completion: 2010-02
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-03
• Last Update Posted: 2016-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 411

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Neramexane mesylate	-
2	Placebo	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
safety parameters	17 weeks
TBF-12 factorial scores, individual responder rate, Tinnitus Rating Scale, Sleep Questionnaire, population pharmacokinetics, optional pharmacogenetics	17 weeks

Trial Locations

Locations (51)

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, Austria

Dr. Elisabeth Kühne; 🇩🇪 Halle, Saale, 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

Scroll for more (41 remaining)