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Efficacy, Safety and Tolerability of Neramexane in Patients With Subjective Tinnitus (EASE)

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ClinicalTrials.gov Identifier: NCT00739635
Recruitment Status : Completed
First Posted : August 22, 2008
Last Update Posted : February 4, 2016
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 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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 411 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 : September 2008
Actual Primary Completion Date : February 2010
Actual Study Completion Date : February 2010

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 Drug: Neramexane mesylate
Double-blind treatment period of 17 weeks up to 75 mg Neramexane mesylate per day
Placebo Comparator: 2 Drug: Placebo
Double-blind treatment period of 17 weeks placebo


Outcome Measures
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Primary Outcome Measures :
  1. TBF-12 (Tinnitus-Beeinträchtigungs-Fragebogen-12 "Tinnitus Handicap 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 responder rate, Tinnitus Rating Scale, Sleep Questionnaire, population pharmacokinetics, optional pharmacogenetics [ Time Frame: 17 weeks ]
  2. safety parameters [ Time Frame: 17 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

Inclusion Criteria:

  • Patients aged 18 to 75 years with a clinical diagnosis of first onset,
  • Persistent (i.e. tinnitus should never be absent for > 24 hours in a row), subjective, uni- or bilateral tinnitus 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, Menière's disease, otosclerosis, etc)
Contacts and Locations
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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): NCT00739635


Locations
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Sponsors and Collaborators
Merz Pharmaceuticals GmbH
More Information
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Additional Information:

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Responsible Party: Merz Pharmaceuticals GmbH
ClinicalTrials.gov Identifier: NCT00739635    
Other Study ID Numbers: MRZ 92579/TI/3001
EudraCT Number 2007-007835-16
First Posted: August 22, 2008    Key Record Dates
Last Update Posted: February 4, 2016
Last Verified: February 2016
Additional relevant MeSH terms:
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Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
 Sensation Disorders
Neurologic Manifestations
Nervous System Diseases