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Efficacy, Safety and Tolerability of Neramexane in Comparison to Placebo in Patients With Subjective Tinnitus

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ClinicalTrials.gov Identifier: NCT00772980
Recruitment Status : Completed
First Posted : October 15, 2008
Last Update Posted : July 1, 2010
Sponsor:
Information provided by:
Merz Pharmaceuticals GmbH

Brief Summary:
The purpose of this study is to investigate the safety and efficacy of neramexane mesylate in the treatment of subjective tinnitus in comparison to placebo.

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Clinical Evaluation of the Efficacy, Safety and Tolerability of Neramexane in Patients With Subjective Tinnitus
Study Start Date : November 2008
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tinnitus
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Drug: Neramexa mesylate Double-blind treatment period of 17 weeks up to 75 mg Neramexane mesylate per day
Drug: Neramexane mesylate
Double-blind treatment period of 17 weeks up to 75 mg Neramexane mesylate per day, 12 weeks follow-up.
Placebo Comparator: 2
Drug: Placebo Double-blind treatment period of 17 weeks placebo
Drug: Placebo
Double-blind treatment period of 17 weeks placebo, 12 weeks follow-up.



Primary Outcome Measures :
  1. TBF-12 (Tinnitus-Beeinträchtigungs-Fragebogen-12 "Tinnitus Handycap Inventory-12") total score change from baseline to end of treatment [ Time Frame: Screening, Baseline, week 5, 13, 17 ]

Secondary Outcome Measures :
  1. TBF-12 factorial scores, individual respond rate, Tinnitus Rating Scale, Sleep Questionnaire, Qualitiy Of Life, population pharmacokinetics, optional pharmacogenetics [ Time Frame: 29 weeks ]
  2. safety parameters [ Time Frame: 29 weeks ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients aged 18 to 75 years with a clinical diagnosis of first onset, persistent (i.e. tinnitus sghould never be absent for >24 hours in a row), subjective, uni-or bilateral tinntius present for at least 3 months but not more than 12 months.

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.)

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): NCT00772980


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Sponsors and Collaborators
Merz Pharmaceuticals GmbH

Responsible Party: Dr. Irena Pulte, Merz Pharmaceuticals GmbH
ClinicalTrials.gov Identifier: NCT00772980     History of Changes
Other Study ID Numbers: MRZ 92579/TI/3002
EudraCT Number 2008-000639-16
First Posted: October 15, 2008    Key Record Dates
Last Update Posted: July 1, 2010
Last Verified: June 2010

Additional relevant MeSH terms:
Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms