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

This study has been completed.
Sponsor:
Information provided by:
Merz Pharmaceuticals GmbH
ClinicalTrials.gov Identifier:
NCT00739635
First received: August 21, 2008
Last updated: March 25, 2010
Last verified: March 2010

August 21, 2008
March 25, 2010
September 2008
February 2010   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00739635 on ClinicalTrials.gov Archive Site
  • TBF-12 factorial scores, individual responder rate, Tinnitus Rating Scale, Sleep Questionnaire, population pharmacokinetics, optional pharmacogenetics [ Time Frame: 17 weeks ] [ Designated as safety issue: No ]
  • safety parameters [ Time Frame: 17 weeks ] [ Designated as safety issue: Yes ]
TBF-12 factorial scores, individual responder rate, Tinnitus Rating Scale, Sleep Questionnaire, safety parameters, population pharmacokinetics, optional pharmacogenetics
Not Provided
Not Provided
 
Efficacy, Safety and Tolerability of Neramexane in Patients With Subjective Tinnitus
A Randomized, Double-Blind, Placebo-Controlled, Clinical Evaluation of the Efficacy, Safety and Tolerability of Neramexane in Patients With Subjective Tinnitus

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Subjective Tinnitus
  • Drug: Neramexane mesylate
    Double-blind treatment period of 17 weeks up to 75 mg Neramexane mesylate per day
  • Drug: Placebo
    Double-blind treatment period of 17 weeks placebo
  • Experimental: 1
    Intervention: Drug: Neramexane mesylate
  • Placebo Comparator: 2
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
400
February 2010
February 2010   (final data collection date for primary outcome measure)

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)
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Austria,   United Kingdom,   Germany,   Spain,   Portugal
 
NCT00739635
MRZ 92579/TI/3001, EudraCT Number 2007-007835-16
No
Irena Pulte, MD, Clinical R & D CNS
Merz Pharmaceuticals GmbH
Not Provided
Not Provided
Merz Pharmaceuticals GmbH
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP