NCT00827008

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

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 821 (actual)
• Sponsor: Merz Pharmaceuticals GmbH · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Conditions

• Subjective Tinnitus

Interventions

Type	Name	Description
DRUG	Neramexane mesylate	Up-titration treatment period of 5 weeks up to 75mg Neramexane mesylate oral per day followed by 49 weeks treatment maintenance

Timeline

• Start date: 2009-01-01
• Primary completion: 2011-12-01
• Completion: 2011-12-01
• First posted: 2009-01-22
• Last updated: 2012-11-28

Locations

135 sites across 14 countries: United States, Austria, Belgium, Brazil, Czechia, France, Germany, Mexico, Netherlands, Poland, Portugal, South Africa, Spain, United Kingdom