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

NCT00827008 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 821

Last updated 2012-11-28

No results posted yet for this study

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

DRUG

Neramexane mesylate

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

Sponsors & Collaborators

  • Merz Pharmaceuticals GmbH

    lead INDUSTRY

Principal Investigators

  • Medical Expert · Merz Pharmaceuticals

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2011-12-31
Completion
2011-12-31

Countries

  • United States
  • Austria
  • Belgium
  • Brazil
  • Czechia
  • France
  • Germany
  • Mexico
  • Netherlands
  • Poland
  • Portugal
  • South Africa
  • Spain
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00827008 on ClinicalTrials.gov