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

History of Changes

Tracking Information
First Received Date ^ICMJE	August 21, 2008
Last Updated Date	March 25, 2010
Start Date ^ICMJE	September 2008
Primary Completion Date	February 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: August 21, 2008)	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 ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00739635 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: September 2, 2009)	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 ]
Original Secondary Outcome Measures ^ICMJE (submitted: August 21, 2008)	TBF-12 factorial scores, individual responder rate, Tinnitus Rating Scale, Sleep Questionnaire, safety parameters, population pharmacokinetics, optional pharmacogenetics
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Efficacy, Safety and Tolerability of Neramexane in Patients With Subjective Tinnitus
Official Title ^ICMJE	A Randomized, Double-Blind, Placebo-Controlled, Clinical Evaluation of the Efficacy, Safety and Tolerability of Neramexane in Patients With Subjective Tinnitus
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Subjective Tinnitus
Intervention ^ICMJE	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
Study Arm (s)	Experimental: 1 Intervention: Drug: Neramexane mesylate Placebo Comparator: 2 Intervention: Drug: Placebo
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	400
Completion Date	February 2010
Primary Completion Date	February 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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)
Gender	Both
Ages	18 Years to 75 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Austria, Germany, Portugal, Spain, United Kingdom

Administrative Information
NCT Number ^ICMJE	NCT00739635
Other Study ID Numbers ^ICMJE	MRZ 92579/TI/3001, EudraCT Number 2007-007835-16
Has Data Monitoring Committee	No
Responsible Party	Irena Pulte, MD, Clinical R & D CNS
Study Sponsor ^ICMJE	Merz Pharmaceuticals GmbH
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Merz Pharmaceuticals GmbH
Verification Date	March 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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