An Open-Label, Long-Term Treatment Study to Assess the Long-Term Safety and Tolerability and Efficacy of Neramexane With Subjective Tinnitus

Merz Pharmaceuticals GmbH134 sites in 6 countries821 target enrollmentJanuary 2009

ConditionsSubjective Tinnitus

InterventionsNeramexane mesylate

DrugsNeramexane mesylate

Overview

Phase: Phase 3
Intervention: Neramexane mesylate
Conditions: Subjective Tinnitus
Sponsor: Merz Pharmaceuticals GmbH
Enrollment: 821
Locations: 134
Primary Endpoint: Descriptive analyses of TBF-12 (Tinnitus-Beeinträchtigungs-Fragebogen 12 "Tinnitus Handicap Inventory 12")total score and its subscores, of the Tinnitus Rating Scale and its single items as well as of SF-36 and safety/tolerability parameters
Status: Terminated
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to investigate the long-term safety and tolerability and efficacy of neramexane mesylate in the long-term treatment of subjective tinnitus after a completed double-blind randomized placebo controlled study

Registry

clinicaltrials.gov

Start Date

January 2009

End Date

December 2011

Last Updated

13 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Merz Pharmaceuticals GmbH

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or female patients who have successfully completed one of the double-blind Phase 3 tinnitus studies of Merz with Neramexane mesylate
•patients aged equal or older 18 but not older than 75 years with clinical diagnosis of first onset, persistent (i.e. tinnitus should never be absent for more than 24 hours in a row), subjective, uni-or bilateral subacute tinnitus at the timepoint of the lead-in study

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, Meniére´s disease, otosclerosis etc.)

Arms & Interventions

1, verum

Intervention: Neramexane mesylate

Outcomes

Primary Outcomes

Descriptive analyses of TBF-12 (Tinnitus-Beeinträchtigungs-Fragebogen 12 "Tinnitus Handicap Inventory 12")total score and its subscores, of the Tinnitus Rating Scale and its single items as well as of SF-36 and safety/tolerability parameters

Time Frame: 54 weeks