Clinical trial NCT00955799: Efficacy, Safety, Tolerability of Neramexane in Patients With Subjective Tinnitus
Official title: A Randomized, Double-Blind, Placebo-Controlled, Clinical Evaluation of the Efficacy, Safety and Tolerability of Neramexane in Patients With Subjective Tinnitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Subjective Tinnitus
Keywords: Subjective, Tinnitus
Lead sponsor: Merz Pharmaceuticals GmbH
Sponsor class: INDUSTRY
First posted: 2009-08-10
Enrollment: 455
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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)

Primary outcomes:
measure: Absolute Change in TBF-12 (Tinnitus Handicap Inventory-12) Total Score from Baseline.
timeFrame: Baseline to week 17 and 29
measure: Absolute Change in TSSw (Tinnitus Severity Scale - One Week Version) Total Score from Baseline.
timeFrame: Baseline to week 17 and 29
Secondary outcomes:
measure: TBF-12 Total Score: Change from Baseline
timeFrame: Baseline to week 5, 17, 23, and 29
measure: TBF-12 Factorial Scores: Change from Baseline
timeFrame: Baseline to week 5, 17, 23, and 29
measure: TBF-12: Individual Responder Rate
timeFrame: Week 5, 17, 23, and 29
measure: Tinnitus Rating Scale (one week version): Change from Baseline
timeFrame: Baseline to week 5, 17, 23, and 29
measure: Tinnitus Severity Scale (one week version): Change from Baseline
timeFrame: Baseline to week 5, 17, 23, and 29
measure: Attention and Performance Self-Assessment (ASPA) Questionnaire: Change from Baseline
timeFrame: Baseline to week 5, 17, 23, and 29
measure: Quality of Life Questionnaire (SF-36™ Health Survey): Change from Baseline
timeFrame: Baseline to week 17 and 29
measure: Hospital Anxiety and Depression Scale (HADS): Change from Baseline
timeFrame: Baseline to week 17 and 29
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: Horizon Clinical Research Associates PLLC
state: Arizona
city: Phoenix
country: United States
facility: Phoenix Clinical
state: Arizona
city: Tucson
country: United States
facility: Paradigm Clinical Research
state: Arizona
city: Burbank
country: United States
facility: Providence Clinical Research
state: California
city: Fresno
country: United States
facility: Central California Clinical Research
state: California
city: Sacramento
country: United States
facility: UC Davis Health System
state: California
city: Colorado Springs
country: United States
facility: Colorado Otolaryngology Associates
state: Colorado
city: Golden
country: United States
facility: New West Physicians
state: Colorado
city: Boynton Beach,
country: United States
facility: Visions Clinical Research
state: Florida
city: Clearwater
country: United States
facility: Tampa Bay Medical Research
state: Florida
city: Tampa
country: United States
facility: Clinical Research of West Florida, Inc.
state: Florida
city: Gurnee
country: United States
facility: Deerpath Physicians Group
state: Illinois
city: Peoria
country: United States
facility: Knight Center for Integrated Health
state: Illinois
city: Evansville
country: United States
facility: Deaconess Clinic, Inc.
state: Indiana
city: Evansville
country: United States
facility: MediSphere Medical Research Center, LLC
state: Indiana
city: Newburgh
country: United States
facility: Deaconess Clinic, Inc.
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa Hospitals & Clinics
state: Iowa
city: Kansas City
country: United States
facility: University of Kansas; Department of Otolaryngology Head & Neck Surgery
state: Kansas
city: Wichita
country: United States
facility: Heartland Research Associates, LLC.
state: Kansas
city: Wichita
country: United States
facility: Heartland Research Associates, LLC.
state: Kansas
city: Louisville
country: United States
facility: Commonwealth Ear, Nose & Throat
state: Kentucky
city: Kalispell
country: United States
facility: Glacier Ear, Nose, and Throat, Head and Neck Surgery, P.C.
state: Montana
city: Bloomfield
country: United States
facility: Immedicenter
state: New Jersey
city: Somerville
country: United States
facility: David L. Bortniker
state: New Jersey
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Buffalo
country: United States
facility: Erie County Medical Center, Department of Rehabilitation Medicine; State University of New York at Buffalo
state: New York
city: Cary
country: United States
facility: Cary Medical Research
state: North Carolina
city: Raleigh
country: United States
facility: Wake Research Associates, LLC
state: North Carolina
city: Wilmington
country: United States
facility: Wilmington Medical Research
state: North Carolina
city: Winston-Salem
country: United States
facility: Piedmont Medical Research
state: North Carolina
city: Charleston
country: United States
facility: Medical University of South Carlolina, Otolaryngology
state: South Carolina
city: Austin
country: United States
facility: Austin Ear, Nose and Throat Clinic
state: Texas
city: Austin
country: United States
facility: Future Search Trials of Neurology
state: Texas
city: Dallas
country: United States
facility: FutureSearch Trials of Dallas
state: Texas
city: Lake Jackson
country: United States
facility: R/D Clinical Research, Inc.
state: Texas
city: Laredo
country: United States
facility: South Texas Research Alliance LLC
state: Texas
city: Plano
country: United States
facility: Research Across America
state: Texas
city: West Jordon
country: United States
facility: Advanced Clinical Research
state: Utah
city: Newport News
country: United States
facility: Health Research of Hampton Roads, Inc.
state: Virginia
city: Graz
country: Austria
facility: Krankenhaus der Elisabethinen
city: Kufstein
country: Austria
facility: Bezirkskrankenhaus Kufstein
city: Linz
country: Austria
facility: A. ö. Krankenhaus der Elisabethinen Linz
city: Wien
country: Austria
facility: Clin Pharm International GmbH, Zentrum Wien
city: Bello Horizonte
country: Brazil
facility: Consultório Dr. Marcelo Rates
city: Rio de Janeiro
country: Brazil
facility: Instituto de Otorrinolaringologia Linhares
city: Rio Grande do Sul
country: Brazil
facility: Hospital de Clinicas de Porto Alegre
city: Santo André/SP
country: Brazil
facility: Faculdade de Medicina do ABC
city: Sao Paulo/ SP
country: Brazil
facility: Universidade Federal de São Paulo - UNIFESP
city: São Paulo/SP
country: Brazil
facility: Instituto Ganz Sanchez
city: Valenca
country: Brazil
facility: Clínica OTOSUL
city: Berlin
country: Germany
facility: Klin. Forschung Berlin Buch GmbH
city: Braunschweig
country: Germany
facility: Praxis im Schlosscarree
city: Darmstadt
country: Germany
facility: Dr. Klaus Peter Jayme
city: Dresden
country: Germany
facility: Dr. Christian Dörr
city: Halle/ Saale
country: Germany
facility: Dr. Elisabeth Kühne
city: Heiligenhaus
country: Germany
facility: Dr. Werner Gieselmann
city: Iserlohn
country: Germany
facility: Dr. Wolfgang Lotte
city: Leipzig
country: Germany
facility: ClinPharm International GmbH
city: Lichtenfels
country: Germany
facility: HNO Praxis, Bamberger Str. 7
city: Lorsch
country: Germany
facility: Dr. Dannesberger
city: München
country: Germany
facility: LMU München, Klinikum Großhadern
city: Nürnberg
country: Germany
facility: Dr. Susanne Wiedemann
city: Aguascalientes
country: Mexico
facility: Instituto Biomédico de Investigación A.C.
city: Chihuahua
country: Mexico
facility: Hospital General de Chihuahua
city: Chihuahua
country: Mexico
facility: Hospital Christus Muguerza del Parque
city: Edo. de México
country: Mexico
facility: Clinical Research Instutute S.C.
city: Guadalajara Jalisco
country: Mexico
facility: Hospital Civil de Guadalajara "Fray Antonio Alcalde", Servicio de Otorrinolaringología; Hospital No. 278
city: Guadalajara Jalisco
country: Mexico
facility: Grupo Médico Terranova
city: Jalisco
country: Mexico
facility: Unidad de Investigación Clínica Cardiometábolica de Occidente S.C. (UNICAMO)
city: México D.F.
country: Mexico
facility: Hospital General de México S.S. O.D.; Servicio de Otorrinolaringología
city: Nuevo León
country: Mexico
facility: Hospital OCA Monterrey International Research Center (MIRC)
city: Nuevo León
country: Mexico
facility: Hospital Universitario
city: Nuevo León
country: Mexico
facility: Unidad de Tratamientos Avanzados (UTRAV) S.C.
city: San Luis Potosí
country: Mexico
facility: Hospital Central "Dr. Ignacio Morones Prieto"; Servicio de Otorrinolaringología
city: San Luis Potosí
country: Mexico
facility: Medicentro del Parque
city: Sinaloa
country: Mexico
facility: Unidad Médica de Especialidades del Noroeste (UMEN)
Study officials:
affiliation: Merz Pharmaceuticals
name: Medical Expert
role: STUDY_DIRECTOR
References: