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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 (OLLTT)

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ClinicalTrials.gov Identifier: NCT00827008
Recruitment Status : Terminated
First Posted : January 22, 2009
Last Update Posted : November 28, 2012
Sponsor:
Information provided by (Responsible Party):
Merz Pharmaceuticals GmbH

Study Description
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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

Condition or disease Intervention/treatment Phase
Subjective Tinnitus Drug: Neramexane mesylate Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 821 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Long-Term Treatment Study to Assess the Long-Term Safety and Tolerability and Efficacy of Neramexane With Subjective Tinnitus
Study Start Date : January 2009
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tinnitus

Arms and Interventions
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Arm Intervention/treatment
Experimental: 1, verum Drug: Neramexane mesylate
Up-titration treatment period of 5 weeks up to 75mg Neramexane mesylate oral per day followed by 49 weeks treatment maintenance


Outcome Measures
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Primary Outcome Measures :
  1. 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 [ Time Frame: 54 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00827008


Locations
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Sponsors and Collaborators
Merz Pharmaceuticals GmbH
Investigators
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Study Director: Medical Expert Merz Pharmaceuticals
More Information
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Responsible Party: Merz Pharmaceuticals GmbH
ClinicalTrials.gov Identifier: NCT00827008    
Other Study ID Numbers: MRZ 92579/TI/3004
2008-001432-13 ( EudraCT Number )
First Posted: January 22, 2009    Key Record Dates
Last Update Posted: November 28, 2012
Last Verified: November 2012
Additional relevant MeSH terms:
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Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
 Sensation Disorders
Neurologic Manifestations
Nervous System Diseases