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

Phase 3

Terminated

• Conditions: Subjective Tinnitus
• Interventions: Drug: Neramexane mesylate

• Registration Number: NCT00827008
• Lead Sponsor: Merz Pharmaceuticals GmbH

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-01-21
• Study First Submitted QC: 2009-01-21
• Study First Posted: 2009-01-22
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2012-11
• Disposition First Submitted: 2012-11-27
• Disposition First Submitted QC: 2012-11-27
• Last Update Submitted: 2012-11-27
• Disposition First Posted: 2012-11-28
• Last Update Posted: 2012-11-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 821

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.)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1, verum	Neramexane mesylate	-

Primary Outcome Measures

Name	Time	Method
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	54 weeks

Trial Locations

Locations (134)

Paradigm Clinical Research; 🇺🇸 Tucson, Arizona, United States

Providence Clinical Research; 🇺🇸 Burbank, California, United States

Central California Clinical Research; 🇺🇸 Fresno, California, United States

UC Davis Health System Department of Otolaryngology; 🇺🇸 Sacramento, California, United States

Colorado Otolaryngology Associates; 🇺🇸 Colorado Springs, Colorado, United States

New West Physicians; 🇺🇸 Golden, Colorado, United States

Visions Clinical Research; 🇺🇸 Boynton Beach, Florida, United States

Clinical Research of West Florida; 🇺🇸 Tampa, Florida, United States

Deerpath Physicians Group; 🇺🇸 Gurnee, Illinois, United States

Knight Center for Integrated Health,; 🇺🇸 Peoria, Illinois, United States

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