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

NCT00955799 | Completed Phase 3

• 2 other identifiers: MRZ 92579/TI/30032009-011246-25
• Study Type: interventional
• Target: 455
• Locations: 5 countries
• Sites: 76

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.

Conditions

Subjective Tinnitus

Keywords

Subjective, Tinnitus

Outcome Measures

Primary Outcomes (2)

• Absolute Change in TBF-12 (Tinnitus Handicap Inventory-12) Total Score from Baseline.

  The TBF-12 is an adapted German version of the original English THI (Tinnitus Handicap Inventory). It is a self-report questionnaire assessing 12 items from 2 dimensions: emotional-cognitive factors and functional-communicational factors. Each item is rated with 0-2 (2= "often"; 1= "sometimes"; 0= "never"). The maximum score is 24 indicating most severe tinnitus impairment. Hierarchical test procedure: Step 1: week 29 in subjects reporting acute hearing loss; step 2: week 17, ditto; step 3: week 29 in total population; step 4: week 17, ditto.

  Baseline to week 17 and 29

• Absolute Change in TSSw (Tinnitus Severity Scale - One Week Version) Total Score from Baseline.

  The TSSw is a measure of tinnitus severity. It will be self-evaluated by the patient at various time points on an 11-point Likert-like scale asking for the past week. The scores range from 0 (indicating no tinnitus) to the maximum score of 10 (characterizing the most severe tinnitus considered). Hierarchical test procedure: Step 1: week 29 in subjects reporting acute hearing loss; step 2: week 17, ditto; step 3: week 29 in total population; step 4: week 17, ditto.

  Baseline to week 17 and 29

Secondary Outcomes (8)

• TBF-12 Total Score: Change from Baseline

  Baseline to week 5, 17, 23, and 29

• TBF-12 Factorial Scores: Change from Baseline

  Baseline to week 5, 17, 23, and 29

• TBF-12: Individual Responder Rate

  Week 5, 17, 23, and 29

• Tinnitus Rating Scale (one week version): Change from Baseline

  Baseline to week 5, 17, 23, and 29

• Tinnitus Severity Scale (one week version): Change from Baseline

  Baseline to week 5, 17, 23, and 29

Study Arms (2)

Neramexane mesylate

EXPERIMENTAL

Double-blind treatment period of 29 weeks up to 75 mg Neramexane mesylate per day

Drug: Neramexane mesylate

Placebo

PLACEBO COMPARATOR

Placebo: identical placebo tablets

Drug: Placebo

Interventions

Neramexane mesylate DRUG

Double-blind treatment period of 29 weeks up to 75 mg Neramexane mesylate per day

Neramexane mesylate

Placebo DRUG

Double-blind treatment period of 29 weeks placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Merz Pharmaceuticals GmbH: lead

Study Sites (76)

Horizon Clinical Research Associates PLLC

Gilbert, Arizona, 85295, United States

Location

Phoenix Clinical

Phoenix, Arizona, 85015, United States

Location

Paradigm Clinical Research

Tucson, Arizona, 85705, United States

Location

Providence Clinical Research

Burbank, California, 91505, United States

Location

Central California Clinical Research

Fresno, California, 93720, United States

Location

UC Davis Health System

Sacramento, California, 95817, United States

Location

Colorado Otolaryngology Associates

Colorado Springs, Colorado, 80909, United States

Location

New West Physicians

Golden, Colorado, 80401, United States

Location

Visions Clinical Research

Boynton Beach, Florida, 33472, United States

Location

Tampa Bay Medical Research

Clearwater, Florida, 33761, United States

Location

Clinical Research of West Florida, Inc.

Tampa, Florida, 33603, United States

Location

Deerpath Physicians Group

Gurnee, Illinois, 60031, United States

Location

Knight Center for Integrated Health

Peoria, Illinois, 61614, United States

Location

Deaconess Clinic, Inc.

Evansville, Indiana, 47710, United States

Location

MediSphere Medical Research Center, LLC

Evansville, Indiana, 47714, United States

Location

Deaconess Clinic, Inc.

Newburgh, Indiana, 47630, United States

Location

University of Iowa Hospitals & Clinics

Iowa City, Iowa, 52242-1078, United States

Location

University of Kansas; Department of Otolaryngology Head & Neck Surgery

Kansas City, Kansas, 66160-0001, United States

Location

Heartland Research Associates, LLC.

Wichita, Kansas, 67205, United States

Location

Heartland Research Associates, LLC.

Wichita, Kansas, 67207, United States

Location

Commonwealth Ear, Nose & Throat

Louisville, Kentucky, 40207, United States

Location

Glacier Ear, Nose, and Throat, Head and Neck Surgery, P.C.

Kalispell, Montana, 59901, United States

Location

Immedicenter

Bloomfield, New Jersey, 07003, United States

Location

David L. Bortniker

Somerville, New Jersey, 08876, United States

Location

Erie County Medical Center, Department of Rehabilitation Medicine; State University of New York at Buffalo

Buffalo, New York, 14221, United States

Location

Montefiore Medical Center

The Bronx, New York, 10867, United States

Location

Cary Medical Research

Cary, North Carolina, 27518, United States

Location

Wake Research Associates, LLC

Raleigh, North Carolina, 27612, United States

Location

Wilmington Medical Research

Wilmington, North Carolina, 28401, United States

Location

Piedmont Medical Research

Winston-Salem, North Carolina, 27103, United States

Location

Medical University of South Carlolina, Otolaryngology

Charleston, South Carolina, 29425, United States

Location

Austin Ear, Nose and Throat Clinic

Austin, Texas, 78705, United States

Location

Future Search Trials of Neurology

Austin, Texas, 78756, United States

Location

FutureSearch Trials of Dallas

Dallas, Texas, 75231, United States

Location

R/D Clinical Research, Inc.

Lake Jackson, Texas, 77566, United States

Location

South Texas Research Alliance LLC

Laredo, Texas, 78041, United States

Location

Research Across America

Plano, Texas, 75093, United States

Location

Advanced Clinical Research

West Jordon, Utah, 84088, United States

Location

Health Research of Hampton Roads, Inc.

Newport News, Virginia, 23606, United States

Location

Krankenhaus der Elisabethinen

Graz, 8020, Austria

Location

Bezirkskrankenhaus Kufstein

Kufstein, 6330, Austria

Location

A. ö. Krankenhaus der Elisabethinen Linz

Linz, 4010, Austria

Location

Clin Pharm International GmbH, Zentrum Wien

Vienna, 1090, Austria

Location

Consultório Dr. Marcelo Rates

Belo Horizonte, 30150-270, Brazil

Location

Instituto de Otorrinolaringologia Linhares

Rio de Janeiro, Brazil

Location

Hospital de Clinicas de Porto Alegre

Rio Grande, 90035-001, Brazil

Location

Faculdade de Medicina do ABC

Santo André/SP, Brazil

Location

Universidade Federal de São Paulo - UNIFESP

Sao Paulo/ SP, Brazil

Location

Instituto Ganz Sanchez

São Paulo/SP, 05469-000, Brazil

Location

Clínica OTOSUL

Valença, Brazil

Location

Klin. Forschung Berlin Buch GmbH

Berlin, 13125, Germany

Location

Praxis im Schlosscarree

Braunschweig, 38100, Germany

Location

Dr. Klaus Peter Jayme

Darmstadt, 64283, Germany

Location

Dr. Christian Dörr

Dresden, 01277, Germany

Location

Dr. Elisabeth Kühne

Halle, 06112, Germany

Location

Dr. Werner Gieselmann

Heiligenhaus, 42579, Germany

Location

Dr. Wolfgang Lotte

Iserlohn, 58642, Germany

Location

ClinPharm International GmbH

Leipzig, 04103, Germany

Location

HNO Praxis, Bamberger Str. 7

Lichtenfels, 96215, Germany

Location

Dr. Dannesberger

Lorsch, 64653, Germany

Location

LMU München, Klinikum Großhadern

München, 81377, Germany

Location

Dr. Susanne Wiedemann

Nuremberg, 90443, Germany

Location

Instituto Biomédico de Investigación A.C.

Aguascalientes, CP 20127, Mexico

Location

Hospital General de Chihuahua

Chihuahua City, C.P. 31000, Mexico

Location

Hospital Christus Muguerza del Parque

Chihuahua City, CP 3100, Mexico

Location

Clinical Research Instutute S.C.

Edo. de México, CP 54055, Mexico

Location

Hospital Civil de Guadalajara "Fray Antonio Alcalde", Servicio de Otorrinolaringología; Hospital No. 278

Guadalajara Jalisco, CP 44280, Mexico

Location

Grupo Médico Terranova

Guadalajara Jalisco, CP 44630, Mexico

Location

Unidad de Investigación Clínica Cardiometábolica de Occidente S.C. (UNICAMO)

Jalisco, 44150, Mexico

Location

Hospital General de México S.S. O.D.; Servicio de Otorrinolaringología

México D.F., 06726, Mexico

Location

Hospital OCA Monterrey International Research Center (MIRC)

Nuevo León, CP 64000, Mexico

Location

Hospital Universitario

Nuevo León, CP 64400, Mexico

Location

Unidad de Tratamientos Avanzados (UTRAV) S.C.

Nuevo León, CP64240, Mexico

Location

Hospital Central "Dr. Ignacio Morones Prieto"; Servicio de Otorrinolaringología

San Luis Potosí City, 78240, Mexico

Location

Medicentro del Parque

San Luis Potosí City, C.P. 78269, Mexico

Location

Unidad Médica de Especialidades del Noroeste (UMEN)

Sinaloa, 80000, Mexico

Location

MeSH Terms

Conditions

Tinnitus

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Medical Expert

  Merz Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2009
• First Posted: August 10, 2009
• Study Start: September 1, 2009
• Primary Completion: May 1, 2011
• Study Completion: June 1, 2011
• Last Updated: November 28, 2012

Record last verified: 2012-11

Locations

US (39); AU (4); BR (7); ME (14); DE (12)