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

Subjective Tinnitus Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-Controlled, Clinical Evaluation of the Efficacy, Safety and Tolerability of Neramexane in Patients With Subjective Tinnitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00772980
• Other study ID #: MRZ 92579/TI/3002
• Secondary ID: EudraCT Number 2
• Status: Completed
• Phase: Phase 3
• First received: October 13, 2008
• Last updated: June 30, 2010
• Start date: November 2008
• Est. completion date: June 2010

Study information

• Verified date: June 2010
• Source: Merz Pharmaceuticals GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Africa: The Registrar of Medicines, Department of Health, Medicines Control CouncilBelgium: DGM - Research & Development, Eurostation, blok 2Czech Republic: Státní Ústav pro Kontrolu Léciv (SÚKL)France: Agence Française de Sécurité Sanitaire des Produits de Santé (AFSSAPS), DEMEB - Unité, ssais CliniquesNetherlands: De Centrale Commissie Mensgebonden OnderzoekPoland: Centralna Ewidencja Badan Klinicznych (CEBK)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Subjective Tinnitus
• Tinnitus

Intervention

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

Locations

Country	Name	City	State
Belgium	AZ Sint Lucas, ENT department	Assebroek-Brugge
Belgium	Clinique Universitaire Saint-Luc	Brussels
Belgium	University Hospital Brussels, ENT department	Brussels
Belgium	Dr. Henri HABERMAN	Bruxelles
Belgium	AZ Sint Lucas, ENT department	Gent
Belgium	Centre hospitalier de jolimont	La Louvière
Belgium	University Hospital Leuven, ENT Department	Leuven
Belgium	CHU Liege Service ORL	Liège
Czech Republic	Prof. MUDr. Ivo Šlapák, CSc	Brno
Czech Republic	Teaching University Hospital, ORL klinika	Brno
Czech Republic	Medico	Chodov	Prague
Czech Republic	Nemocnice Havlíckuv Brod	Havlíckuv Brod
Czech Republic	ORL - Otorynolaryngologické oddelení	Jihlava
Czech Republic	ORL oddelení, Karlovarská krajská nemocncie a.s.	Karlovy Vary
Czech Republic	Oblastní nemocnice Kladno a.s.	Kladno
Czech Republic	Pro-audio,s.r.o.-private ENT clinic	Mladá Boleslav
Czech Republic	ORL oddelení, Všeobecná Fakultní Nemocnice v Praze	Praha
Czech Republic	ORL oddelení , Karlovarská krajská nemocnice a. s.	Sokolov
France	Dr. Ebbo	Issy les moulineaux
France	Dr. Sarfati	La seyne sur Mer
France	Centre Hospitalier de Bretagne Sud Service	Lorient
France	Hopital Edouard Herriot	Lyon cedex 03
France	BONFILS	Paris
France	OHRESSER	Paris
France	Hopital Nord	Saint-Etienne
France	FRAYSSE	Toulouse cedex
France	Service ORL CHU	Tours
France	Hopital Paul BROUSSE Polyclinique	Villejuif
Netherlands	Andromed Breda	Breda
Netherlands	Andromed Leiden	Leiderdorp
Netherlands	Rijnland Ziekenhuis, ENT department	Leiderdorp
Netherlands	Adromed Nijmegen	Nijmegen
Netherlands	Andromed Rotterdam	Rotterdam
Netherlands	Andromed Rotterdam	Rotterdam
Netherlands	Andromed Oost	Velp
Netherlands	Andromed Zoetermeer	Zoetermeer
Poland	Uniwersytecki Szpital Kliniczny w Bialymstoku	Bialystok
Poland	Niepubliczny Zaklad Opieki Zdrowotnej Prywatne Centrum Medyczne PROMEDIS	Gdansk
Poland	Szpital Miejski im. J.Brudzinskiego	Gdynia
Poland	Samodzielny Publiczny Szpital Kliniczny im. Andrzeja Mieleckiego Slaskiego Uniwersytetu Medycznego w Katowicach	Katowice
Poland	Niepubliczny Zaklad Opieki Zdrowotnej PROMED	Krakow
Poland	NZOZ Specjalistyczne Centrum Medyczne Nowomed	Krakow
Poland	Specjalistyczny Gabinet Otolaryngologiczny Dr Anna Otto- Markiewicz	Krakow
Poland	Szpital Specjalistyczny im. Stefana Zeromskiego, SP ZOZ w Krakowie, Oddzial Otolaryngologii	Krakow
Poland	Instytut Medycyny Pracy im. Prof. Dr med. Jerzego Nofera w Lodzi	Lodz
Poland	Samodzielny Publiczny Zaklad Opieki Zdrowotnej, Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi	Lodz
Poland	Wojewodzki Szpital Specjalistyczny im. Stefana Kardynala Wyszynskiego Samodzielny Publiczny Zaklad Opieki Zdrowotnej	Lublin
Poland	Wojewodzki Szpital Specjalistyczny w Olsztynie	Olsztyn
Poland	Instytut Fizjologii i Patologii Sluchu	Warszawa
Poland	Samodzielny Publiczny Szpital Kliniczny nr 1 we Wroclawiu	Wroclaw
South Africa	Louis Leipoldt Mediclinic	Bellville
South Africa	Lakeview Hospital	Benoni
South Africa	Dr. A. Viljoen	Pretoria
South Africa	GCT Eastmed Clinical Trial centre	Pretoria
South Africa	Constantiaberg Medi Clinic	Western Cape
South Africa	Dr. J. Steer	Wynberg

Sponsors (1)

Lead Sponsor	Collaborator
Merz Pharmaceuticals GmbH

Countries where clinical trial is conducted

Belgium,  Czech Republic,  France,  Netherlands,  Poland,  South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	TBF-12 factorial scores, individual respond rate, Tinnitus Rating Scale, Sleep Questionnaire, Qualitiy Of Life, population pharmacokinetics, optional pharmacogenetics		29 weeks	No
Secondary	safety parameters		29 weeks	Yes