Overview

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

Status:
Terminated

Trial end date:
2011-12-01

Target enrollment:
0

Participant gender:
All

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

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Merz Pharmaceuticals GmbH

Criteria

Main 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

Main 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.)