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

This study has been completed.
Sponsor:
Information provided by:
Merz Pharmaceuticals GmbH
ClinicalTrials.gov Identifier:
NCT00772980
First received: October 13, 2008
Last updated: June 30, 2010
Last verified: June 2010
History of Changes
  Purpose

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:

MedlinePlus related topics: Tinnitus
U.S. FDA Resources

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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.)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00772980

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

No publications provided

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
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:
Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
 Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013