Efficacy, Safety and Tolerability of Neramexane in Comparison to Placebo in Patients With Subjective Tinnitus - Full Text View

Sponsored by:	Merz Pharmaceuticals GmbH
Information provided by:	Merz Pharmaceuticals GmbH
ClinicalTrials.gov Identifier:	NCT00772980

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

MedlinePlus related topics: Tinnitus Toe Injuries and Disorders

Drug Information available for: Neramexane Neramexane Mesylate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, 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

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, safety parameters, population pharmacokinetics, optional pharmacogenetics

Estimated Enrollment:	400
Study Start Date:	October 2008

Arms	Assigned Interventions
1: Experimental 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.
2: Placebo Comparator 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

Contacts

Contact: Clariness Clariness

tinnitus@clinlife.net

Locations

Netherlands
Andromed Rotterdam	Recruiting
Rotterdam, Netherlands, HC 3021
Contact: Roos Choudhurry, Dr. 0031-10-4480 ext 800 arts@andromed.nl

Sponsors and Collaborators

Merz Pharmaceuticals GmbH

Investigators

Study Director:

Roos Choudhurry, Dr.

Andromed Rotterdam

More Information

Study ID Numbers:	MRZ 92579/TI/3002, EudraCT Number 2008-000639-16
Study First Received:	October 13, 2008
Last Updated:	October 14, 2008
ClinicalTrials.gov Identifier:	NCT00772980
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 14, 2009