Status:
TERMINATED
Open-Label, Long-Term Treatment Study, to Assess the Long-Term Safety and Tolerability and Efficacy of Neramexane in Patients With Subjective Tinnitus
Lead Sponsor:
Merz Pharmaceuticals GmbH
Conditions:
Subjective Tinnitus
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
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 r...
Eligibility Criteria
Inclusion
- Main
- 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
- 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.)
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
821 Patients enrolled
Trial Details
Trial ID
NCT00827008
Start Date
January 1 2009
End Date
December 1 2011
Last Update
November 28 2012
Active Locations (135)
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1
Paradigm Clinical Research
Tucson, Arizona, United States, 85705
2
Providence Clinical Research
Burbank, California, United States, 91505
3
Central California Clinical Research
Fresno, California, United States, 93720
4
UC Davis Health System Department of Otolaryngology
Sacramento, California, United States, 95817