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

This study has been completed.
Information provided by:
Merz Pharmaceuticals GmbH Identifier:
First received: October 13, 2008
Last updated: June 30, 2010
Last verified: June 2010
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 Intervention Phase
Subjective Tinnitus
Drug: Neramexane mesylate
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

Further study details as provided by Merz Pharmaceuticals GmbH:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • TBF-12 factorial scores, individual respond rate, Tinnitus Rating Scale, Sleep Questionnaire, Qualitiy Of Life, population pharmacokinetics, optional pharmacogenetics [ Time Frame: 29 weeks ] [ Designated as safety issue: No ]
  • safety parameters [ Time Frame: 29 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 400
Study Start Date: November 2008
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.)
  Contacts and Locations
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Please refer to this study by its identifier: NCT00772980

  Show 56 Study Locations
Sponsors and Collaborators
Merz Pharmaceuticals GmbH
  More Information

Responsible Party: Dr. Irena Pulte, Merz Pharmaceuticals GmbH Identifier: NCT00772980     History of Changes
Other Study ID Numbers: MRZ 92579/TI/3002  EudraCT Number 2008-000639-16 
Study First Received: October 13, 2008
Last Updated: June 30, 2010
Health Authority: South Africa: The Registrar of Medicines, Department of Health, Medicines Control Council
Belgium: DGM - Research & Development, Eurostation, blok 2
Czech Republic: Státní Ústav pro Kontrolu Léčiv (SÚKL)
France: Agence Française de Sécurité Sanitaire des Produits de Santé (AFSSAPS), DEMEB - Unité, ssais Cliniques
Netherlands: De Centrale Commissie Mensgebonden Onderzoek
Poland: Centralna Ewidencja Badań Klinicznych (CEBK)

Additional relevant MeSH terms:
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms processed this record on October 25, 2016