Efficacy, Safety, Tolerability of Neramexane in Patients With Subjective Tinnitus

This study is not yet open for participant recruitment.

Verified by Merz Pharmaceuticals GmbH, August 2009

First Received: August 6, 2009 Last Updated: August 7, 2009 History of Changes

Sponsored by:	Merz Pharmaceuticals GmbH
Information provided by:	Merz Pharmaceuticals GmbH
ClinicalTrials.gov Identifier:	NCT00955799

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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 Toe Injuries and Disorders

Drug Information available for: Neramexane Neramexane Mesylate

U.S. FDA Resources

Further study details as provided by Merz Pharmaceuticals GmbH:

Primary Outcome Measures:

TBF-12 (Tinnitus-Beeinträchtigungs-Fragebogen-12 "Tinnitus Handicap Inventory-12") total score change from baseline to end of treatment, TSSw [ Time Frame: Screening, Baseline, week 5, 11, 17, 29 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

See above TBF-12 factorial scores, individual responder rate, Tinnitus Rating Scale, APSA Questionnaire, safety parameters, population pharmacokinetics, optional pharmacogenetics [ Time Frame: 29 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:

400

Arms	Assigned Interventions
Neramexane mesylate: Experimental Double-blind treatment period of 29 weeks up to 75 mg Neramexane mesylate per day	Drug: Neramexane mesylate Double-blind treatment period of 29 weeks up to 75 mg Neramexane mesylate per day
Placebo: Placebo Comparator Placebo: identical placebo tablets	Drug: Placebo Double-blind treatment period of 29 weeks placebo

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Main Inclusion Criteria:

Patients aged between 18 and 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 subacute tinnitus

Main 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00955799

Contacts

Contact: Janos Csikos, MD

49 69 1503 ext 0

Sponsors and Collaborators

Merz Pharmaceuticals GmbH

More Information

Additional Information:

webpage for recruitement of study subjects This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Merz Pharmaceuticals GmbH ( Dr. Janos Csikos )
Study ID Numbers:	MRZ 92579/TI/3003, EudraCT Number 2009-011246-25
Study First Received:	August 6, 2009
Last Updated:	August 7, 2009
ClinicalTrials.gov Identifier:	NCT00955799 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Merz Pharmaceuticals GmbH:

Subjective, Tinnitus

Study placed in the following topic categories:

Signs and Symptoms
Sensation Disorders
Hearing Disorders
Otorhinolaryngologic Diseases

Neurologic Manifestations
Ear Diseases
Tinnitus

Additional relevant MeSH terms:

Signs and Symptoms
Sensation Disorders
Hearing Disorders
Otorhinolaryngologic Diseases

Nervous System Diseases
Neurologic Manifestations
Ear Diseases
Tinnitus

ClinicalTrials.gov processed this record on September 11, 2009