Efficacy, Safety and Tolerability of Neramexane in Comparison to Placebo in Patients With Subjective Tinnitus

NCT00772980 | Completed Phase 3

• 2 other identifiers: MRZ 92579/TI/3002EudraCT Number 2008-000639-16
• Study Type: interventional
• Target: 400
• Locations: 6 countries
• Sites: 56

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

Outcome Measures

Primary Outcomes (1)

• TBF-12 (Tinnitus-Beeinträchtigungs-Fragebogen-12 "Tinnitus Handycap Inventory-12") total score change from baseline to end of treatment

  Screening, Baseline, week 5, 13, 17

Secondary Outcomes (2)

• TBF-12 factorial scores, individual respond rate, Tinnitus Rating Scale, Sleep Questionnaire, Qualitiy Of Life, population pharmacokinetics, optional pharmacogenetics

  29 weeks

• safety parameters

  29 weeks

Study Arms (2)

1

EXPERIMENTAL

Drug: Neramexa mesylate Double-blind treatment period of 17 weeks up to 75 mg Neramexane mesylate per day

Drug: Neramexane mesylate

2

PLACEBO COMPARATOR

Drug: Placebo Double-blind treatment period of 17 weeks placebo

Drug: Placebo

Interventions

Neramexane mesylate DRUG

Double-blind treatment period of 17 weeks up to 75 mg Neramexane mesylate per day, 12 weeks follow-up.

1

Placebo DRUG

Double-blind treatment period of 17 weeks placebo, 12 weeks follow-up.

2

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 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.

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, Meniére´s disease, otosclerosis, etc.)

Sponsors & Collaborators

• Merz Pharmaceuticals GmbH: lead

Study Sites (56)

AZ Sint Lucas, ENT department

Assebroek-Brugge, 8310, Belgium

Location

University Hospital Brussels, ENT department

Brussels, 1090, Belgium

Location

Clinique Universitaire Saint-Luc

Brussels, 1200, Belgium

Location

Dr. Henri HABERMAN

Brussels, 1200, Belgium

Location

AZ Sint Lucas, ENT department

Ghent, 9000, Belgium

Location

Centre hospitalier de jolimont

La Louvière, 7100, Belgium

Location

University Hospital Leuven, ENT Department

Leuven, 3000, Belgium

Location

CHU Liege Service ORL

Liège, 4000, Belgium

Location

Medico

Chodov, Prague, Czechia

Location

Prof. MUDr. Ivo Šlapák, CSc

Brno, 60200, Czechia

Location

Teaching University Hospital, ORL klinika

Brno, 65691, Czechia

Location

Nemocnice Havlíčkův Brod

Havlíčkův Brod, 58022, Czechia

Location

ORL - Otorynolaryngologické oddělení

Jihlava, 58633, Czechia

Location

ORL oddělení, Karlovarská krajská nemocncie a.s.

Karlovy Vary, 36066, Czechia

Location

Oblastní nemocnice Kladno a.s.

Kladno, 27259, Czechia

Location

Pro-audio,s.r.o.-private ENT clinic

Mladá Boleslav, 29301, Czechia

Location

ORL oddělení, Všeobecná Fakultní Nemocnice v Praze

Prague, 12808, Czechia

Location

ORL oddělení , Karlovarská krajská nemocnice a. s.

Sokolov, 35601, Czechia

Location

Dr. Ebbo

Issy-les-Moulineaux, 92130, France

Location

Dr. Sarfati

La Seyne-sur-Mer, 83500, France

Location

Centre Hospitalier de Bretagne Sud Service

Lorient, 56322, France

Location

Hopital Edouard Herriot

Lyon, 69437, France

Location

BONFILS

Paris, 75015, France

Location

OHRESSER

Paris, 75015, France

Location

Hopital Nord

Saint-Etienne, 42055, France

Location

FRAYSSE

Toulouse, 31059, France

Location

Service ORL CHU

Tours, 37044, France

Location

Hopital Paul BROUSSE Polyclinique

Villejuif, 94800, France

Location

Andromed Breda

Breda, 4811 VL, Netherlands

Location

Andromed Leiden

Leiderdorp, 2352 RA, Netherlands

Location

Rijnland Ziekenhuis, ENT department

Leiderdorp, 2353 GA, Netherlands

Location

Adromed Nijmegen

Nijmegen, 6533 HL, Netherlands

Location

Andromed Rotterdam

Rotterdam, 3021 HC, Netherlands

Location

Andromed Rotterdam

Rotterdam, HC 3021, Netherlands

Location

Andromed Oost

Velp, 6883 ES, Netherlands

Location

Andromed Zoetermeer

Zoetermeer, 2724 EK, Netherlands

Location

Uniwersytecki Szpital Kliniczny w Bialymstoku

Bialystok, 15-279, Poland

Location

Niepubliczny Zaklad Opieki Zdrowotnej Prywatne Centrum Medyczne PROMEDIS

Gdansk, 80-288, Poland

Location

Szpital Miejski im. J.Brudzinskiego

Gdynia, 81-348, Poland

Location

Samodzielny Publiczny Szpital Kliniczny im. Andrzeja Mieleckiego Slaskiego Uniwersytetu Medycznego w Katowicach

Katowice, 40-027, Poland

Location

NZOZ Specjalistyczne Centrum Medyczne Nowomed

Krakow, 30-349, Poland

Location

Specjalistyczny Gabinet Otolaryngologiczny Dr Anna Otto- Markiewicz

Krakow, 31-534, Poland

Location

Niepubliczny Zaklad Opieki Zdrowotnej PROMED

Krakow, 31-636, Poland

Location

Szpital Specjalistyczny im. Stefana Zeromskiego, SP ZOZ w Krakowie, Oddzial Otolaryngologii

Krakow, 31-913, Poland

Location

Samodzielny Publiczny Zaklad Opieki Zdrowotnej, Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi

Lodz, 91-153, Poland

Location

Instytut Medycyny Pracy im. Prof. Dr med. Jerzego Nofera w Lodzi

Lodz, 91-348, Poland

Location

Wojewodzki Szpital Specjalistyczny im. Stefana Kardynała Wyszynskiego Samodzielny Publiczny Zaklad Opieki Zdrowotnej

Lublin, 20-718, Poland

Location

Wojewodzki Szpital Specjalistyczny w Olsztynie

Olsztyn, 10-561, Poland

Location

Instytut Fizjologii i Patologii Sluchu

Warsaw, 01-943, Poland

Location

Samodzielny Publiczny Szpital Kliniczny nr 1 we Wroclawiu

Wroclaw, 50-369, Poland

Location

Louis Leipoldt Mediclinic

Bellville, 7530, South Africa

Location

Lakeview Hospital

Benoni, 1501, South Africa

Location

Dr. A. Viljoen

Pretoria, 0002, South Africa

Location

GCT Eastmed Clinical Trial centre

Pretoria, 0186, South Africa

Location

Constantiaberg Medi Clinic

Western Cape, 7800, South Africa

Location

Dr. J. Steer

Wynberg, 7800, South Africa

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 Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 13, 2008
• First Posted: October 15, 2008
• Study Start: November 1, 2008
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: July 1, 2010

Record last verified: 2010-06

Locations

CZ (10); ZA (6); BE (8); FR (10); PL (14); NL (8)