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

Sponsored by:	Merz Pharmaceuticals GmbH
Information provided by:	Merz Pharmaceuticals GmbH
ClinicalTrials.gov Identifier:	NCT00739635

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 [ Time Frame: Screening, Baseline, week 5, 13, 17 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	400
Study Start Date:	September 2008
Estimated Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Neramexane mesylate Double-blind treatment period of 17 weeks up to 75 mg Neramexane mesylate per day
2: Placebo Comparator	Drug: Placebo Double-blind treatment period of 17 weeks placebo

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 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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00739635

Show 54 Study Locations

Sponsors and Collaborators

Merz Pharmaceuticals GmbH

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Clinical R & D CNS ( Janos Csikos, MD )
Study ID Numbers:	MRZ 92579/TI/3001, EudraCT Number 2007-007835-16
Study First Received:	August 21, 2008
Last Updated:	September 7, 2009
ClinicalTrials.gov Identifier:	NCT00739635 History of Changes
Health Authority:	Austria: AGES PharmMed Bundesamt für Sicherheit im Gesundheitswesen; Germany: Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM)Fachregistratur Z 172; Portugal: INFARMED Autoridade Nacional do Medicamento e Produtos de Saúde, I.P.; Spain: Agencia Española de Medicamentos y Productos Sanitarios (AEMPS); UK: MHRA The Clinical Trials Unit, Department of Health

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