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

Sponsor

Merz Pharmaceuticals GmbH (Industry)

Overall Status

Completed

CT.gov ID

NCT00772980

Collaborator

(none)

400

Enrollment

Locations

Arms

Duration (Months)

7.1

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Subjective Tinnitus	Drug: Neramexane mesylate Drug: Placebo	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

400 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Nov 1, 2008

Actual Primary Completion Date :

Jun 1, 2010

Actual Study Completion Date :

Jun 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Drug: Neramexa mesylate Double-blind treatment period of 17 weeks up to 75 mg Neramexane mesylate per day	Drug: Neramexane mesylate Double-blind treatment period of 17 weeks up to 75 mg Neramexane mesylate per day, 12 weeks follow-up.
Placebo Comparator: 2 Drug: Placebo Double-blind treatment period of 17 weeks placebo	Drug: Placebo Double-blind treatment period of 17 weeks placebo, 12 weeks follow-up.

Arm

Intervention/Treatment

Experimental: 1

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

Drug: Neramexane mesylate

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

Placebo Comparator: 2

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

Drug: Placebo

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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	AZ Sint Lucas, ENT department	Assebroek-Brugge		Belgium	8310
2	University Hospital Brussels, ENT department	Brussels		Belgium	1090
3	Clinique Universitaire Saint-Luc	Brussels		Belgium	1200
4	Dr. Henri HABERMAN	Bruxelles		Belgium	1200
5	AZ Sint Lucas, ENT department	Gent		Belgium	9000
6	Centre hospitalier de jolimont	La Louvière		Belgium	7100
7	University Hospital Leuven, ENT Department	Leuven		Belgium	3000
8	CHU Liege Service ORL	Liège		Belgium	4000
9	Medico	Chodov	Prague	Czech Republic
10	Prof. MUDr. Ivo Šlapák, CSc	Brno		Czech Republic	60200
11	Teaching University Hospital, ORL klinika	Brno		Czech Republic	65691
12	Nemocnice Havlíčkův Brod	Havlíčkův Brod		Czech Republic	58022
13	ORL - Otorynolaryngologické oddělení	Jihlava		Czech Republic	58633
14	ORL oddělení, Karlovarská krajská nemocncie a.s.	Karlovy Vary		Czech Republic	36066
15	Oblastní nemocnice Kladno a.s.	Kladno		Czech Republic	27259
16	Pro-audio,s.r.o.-private ENT clinic	Mladá Boleslav		Czech Republic	29301
17	ORL oddělení, Všeobecná Fakultní Nemocnice v Praze	Praha		Czech Republic	12808
18	ORL oddělení , Karlovarská krajská nemocnice a. s.	Sokolov		Czech Republic	35601
19	Dr. Ebbo	Issy les moulineaux		France	92130
20	Dr. Sarfati	La seyne sur Mer		France	83500
21	Centre Hospitalier de Bretagne Sud Service	Lorient		France	56322
22	Hopital Edouard Herriot	Lyon cedex 03		France	69437
23	BONFILS	Paris		France	75015
24	OHRESSER	Paris		France	75015
25	Hopital Nord	Saint-Etienne		France	42055
26	FRAYSSE	Toulouse cedex		France	31059
27	Service ORL CHU	Tours		France	37044
28	Hopital Paul BROUSSE Polyclinique	Villejuif		France	94800
29	Andromed Breda	Breda		Netherlands	4811 VL
30	Andromed Leiden	Leiderdorp		Netherlands	2352 RA
31	Rijnland Ziekenhuis, ENT department	Leiderdorp		Netherlands	2353 GA
32	Adromed Nijmegen	Nijmegen		Netherlands	6533 HL
33	Andromed Rotterdam	Rotterdam		Netherlands	3021 HC
34	Andromed Rotterdam	Rotterdam		Netherlands	HC 3021
35	Andromed Oost	Velp		Netherlands	6883 ES
36	Andromed Zoetermeer	Zoetermeer		Netherlands	2724 EK
37	Uniwersytecki Szpital Kliniczny w Bialymstoku	Bialystok		Poland	15-279
38	Niepubliczny Zaklad Opieki Zdrowotnej Prywatne Centrum Medyczne PROMEDIS	Gdansk		Poland	80-288
39	Szpital Miejski im. J.Brudzinskiego	Gdynia		Poland	81-348
40	Samodzielny Publiczny Szpital Kliniczny im. Andrzeja Mieleckiego Slaskiego Uniwersytetu Medycznego w Katowicach	Katowice		Poland	40-027
41	NZOZ Specjalistyczne Centrum Medyczne Nowomed	Krakow		Poland	30-349
42	Specjalistyczny Gabinet Otolaryngologiczny Dr Anna Otto- Markiewicz	Krakow		Poland	31-534
43	Niepubliczny Zaklad Opieki Zdrowotnej PROMED	Krakow		Poland	31-636
44	Szpital Specjalistyczny im. Stefana Zeromskiego, SP ZOZ w Krakowie, Oddzial Otolaryngologii	Krakow		Poland	31-913
45	Samodzielny Publiczny Zaklad Opieki Zdrowotnej, Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi	Lodz		Poland	91-153
46	Instytut Medycyny Pracy im. Prof. Dr med. Jerzego Nofera w Lodzi	Lodz		Poland	91-348
47	Wojewodzki Szpital Specjalistyczny im. Stefana Kardynała Wyszynskiego Samodzielny Publiczny Zaklad Opieki Zdrowotnej	Lublin		Poland	20-718
48	Wojewodzki Szpital Specjalistyczny w Olsztynie	Olsztyn		Poland	10-561
49	Instytut Fizjologii i Patologii Sluchu	Warszawa		Poland	01-943
50	Samodzielny Publiczny Szpital Kliniczny nr 1 we Wroclawiu	Wroclaw		Poland	50-369
51	Louis Leipoldt Mediclinic	Bellville		South Africa	7530
52	Lakeview Hospital	Benoni		South Africa	1501
53	Dr. A. Viljoen	Pretoria		South Africa	0002
54	GCT Eastmed Clinical Trial centre	Pretoria		South Africa	0186
55	Constantiaberg Medi Clinic	Western Cape		South Africa	7800
56	Dr. J. Steer	Wynberg		South Africa	7800

Sponsors and Collaborators

Merz Pharmaceuticals GmbH

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00772980

Other Study ID Numbers:

MRZ 92579/TI/3002
EudraCT Number 2008-000639-16

First Posted:

Oct 15, 2008

Last Update Posted:

Jul 1, 2010

Last Verified:

Jun 1, 2010

Additional relevant MeSH terms:

Tinnitus

Study Results

No Results Posted as of Jul 1, 2010