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

• Sponsor: Merz Pharmaceuticals GmbH (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00955799
• Collaborator: (none)
• Enrollment: 455
• Locations: 76
• Arms: 2
• Duration (Months): 21
• Patients Per Site: 6
• Patients Per Site Per Month: 0.3

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
• Actual Enrollment: 455 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, 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: Sep 1, 2009
• Actual Primary Completion Date: May 1, 2011
• Actual Study Completion Date: Jun 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Neramexane mesylate Double-blind treatment period of 29 weeks up to 75 mg Neramexane mesylate per day	Drug: Neramexane mesylate; Double-blind treatment period of 29 weeks up to 75 mg Neramexane mesylate per day
Placebo Comparator: Placebo Placebo: identical placebo tablets	Drug: Placebo; Double-blind treatment period of 29 weeks placebo

Outcome Measures

Primary Outcome Measures

1. Absolute Change in TBF-12 (Tinnitus Handicap Inventory-12) Total Score from Baseline. [Baseline to week 17 and 29]

   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.

2. Absolute Change in TSSw (Tinnitus Severity Scale - One Week Version) Total Score from Baseline. [Baseline to week 17 and 29]

   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.

Secondary Outcome Measures

1. TBF-12 Total Score: Change from Baseline [Baseline to week 5, 17, 23, and 29]

   See outcome measure #1.

2. TBF-12 Factorial Scores: Change from Baseline [Baseline to week 5, 17, 23, and 29]

   See outcome measure #1.

3. TBF-12: Individual Responder Rate [Week 5, 17, 23, and 29]

   See outcome measure #1. A subject is considered responder if TBF-12 decreases at least 4 score points between baseline and respective visit.

4. Tinnitus Rating Scale (one week version): Change from Baseline [Baseline to week 5, 17, 23, and 29]

   Tinnitus Rating Scale is a self-evaluated 11-point Likert scale assessing tinnitus loudness, annoyance, and impact on life. The scores range from 0 (no impact), to the maximum score of 10 (worst influence of the problem considered). Single scores and sum scores will be analysed.

5. Tinnitus Severity Scale (one week version): Change from Baseline [Baseline to week 5, 17, 23, and 29]

   See outcome measure #2.

6. Attention and Performance Self-Assessment (ASPA) Questionnaire: Change from Baseline [Baseline to week 5, 17, 23, and 29]

   The ASPA consists of 30 simple statements for which the patient can determine how regular this happens to him/her. The response options for each statement are "never", "seldom", "sometimes", "often" and "always".

7. Quality of Life Questionnaire (SF-36™ Health Survey): Change from Baseline [Baseline to week 17 and 29]

   The SF-36 is a multipurpose health survey with 36 questions. It is a generic measure commonly used in general and specific populations, comparing the relative burden of diseases, and in differentiating the health benefits produced by a wide range of different treatments.

8. Hospital Anxiety and Depression Scale (HADS): Change from Baseline [Baseline to week 17 and 29]

   The HADS is a self-assessment scale with 14 items which has been developed for non psychiatrists to detect states of depression and anxiety in a hospital outpatient population. Every item is rated with a scale (3= very often indeed; 2= quite often; 1= not very often; 0= not at all). Lower total scores indicate "normal", higher total scores "abnormal".

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Horizon Clinical Research Associates PLLC	Gilbert	Arizona	United States	85295
2	Phoenix Clinical	Phoenix	Arizona	United States	85015
3	Paradigm Clinical Research	Tucson	Arizona	United States	85705
4	Providence Clinical Research	Burbank	California	United States	91505
5	Central California Clinical Research	Fresno	California	United States	93720
6	UC Davis Health System	Sacramento	California	United States	95817
7	Colorado Otolaryngology Associates	Colorado Springs	Colorado	United States	80909
8	New West Physicians	Golden	Colorado	United States	80401
9	Visions Clinical Research	Boynton Beach,	Florida	United States	33472
10	Tampa Bay Medical Research	Clearwater	Florida	United States	33761
11	Clinical Research of West Florida, Inc.	Tampa	Florida	United States	33603
12	Deerpath Physicians Group	Gurnee	Illinois	United States	60031
13	Knight Center for Integrated Health	Peoria	Illinois	United States	61614
14	Deaconess Clinic, Inc.	Evansville	Indiana	United States	47710
15	MediSphere Medical Research Center, LLC	Evansville	Indiana	United States	47714
16	Deaconess Clinic, Inc.	Newburgh	Indiana	United States	47630
17	University of Iowa Hospitals & Clinics	Iowa City	Iowa	United States	52242-1078
18	University of Kansas; Department of Otolaryngology Head & Neck Surgery	Kansas City	Kansas	United States	66160-0001
19	Heartland Research Associates, LLC.	Wichita	Kansas	United States	67205
20	Heartland Research Associates, LLC.	Wichita	Kansas	United States	67207
21	Commonwealth Ear, Nose & Throat	Louisville	Kentucky	United States	40207
22	Glacier Ear, Nose, and Throat, Head and Neck Surgery, P.C.	Kalispell	Montana	United States	59901
23	Immedicenter	Bloomfield	New Jersey	United States	07003
24	David L. Bortniker	Somerville	New Jersey	United States	08876
25	Montefiore Medical Center	Bronx	New York	United States	10867
26	Erie County Medical Center, Department of Rehabilitation Medicine; State University of New York at Buffalo	Buffalo	New York	United States	14221
27	Cary Medical Research	Cary	North Carolina	United States	27518
28	Wake Research Associates, LLC	Raleigh	North Carolina	United States	27612
29	Wilmington Medical Research	Wilmington	North Carolina	United States	28401
30	Piedmont Medical Research	Winston-Salem	North Carolina	United States	27103
31	Medical University of South Carlolina, Otolaryngology	Charleston	South Carolina	United States	29425
32	Austin Ear, Nose and Throat Clinic	Austin	Texas	United States	78705
33	Future Search Trials of Neurology	Austin	Texas	United States	78756
34	FutureSearch Trials of Dallas	Dallas	Texas	United States	75231
35	R/D Clinical Research, Inc.	Lake Jackson	Texas	United States	77566
36	South Texas Research Alliance LLC	Laredo	Texas	United States	78041
37	Research Across America	Plano	Texas	United States	75093
38	Advanced Clinical Research	West Jordon	Utah	United States	84088
39	Health Research of Hampton Roads, Inc.	Newport News	Virginia	United States	23606
40	Krankenhaus der Elisabethinen	Graz		Austria	8020
41	Bezirkskrankenhaus Kufstein	Kufstein		Austria	6330
42	A. ö. Krankenhaus der Elisabethinen Linz	Linz		Austria	4010
43	Clin Pharm International GmbH, Zentrum Wien	Wien		Austria	1090
44	Consultório Dr. Marcelo Rates	Bello Horizonte		Brazil	30150-270
45	Instituto de Otorrinolaringologia Linhares	Rio de Janeiro		Brazil
46	Hospital de Clinicas de Porto Alegre	Rio Grande do Sul		Brazil	90035-001
47	Faculdade de Medicina do ABC	Santo André/SP		Brazil
48	Universidade Federal de São Paulo - UNIFESP	Sao Paulo/ SP		Brazil
49	Instituto Ganz Sanchez	São Paulo/SP		Brazil	05469-000
50	Clínica OTOSUL	Valenca		Brazil
51	Klin. Forschung Berlin Buch GmbH	Berlin		Germany	13125
52	Praxis im Schlosscarree	Braunschweig		Germany	38100
53	Dr. Klaus Peter Jayme	Darmstadt		Germany	64283
54	Dr. Christian Dörr	Dresden		Germany	01277
55	Dr. Elisabeth Kühne	Halle/ Saale		Germany	06112
56	Dr. Werner Gieselmann	Heiligenhaus		Germany	42579
57	Dr. Wolfgang Lotte	Iserlohn		Germany	58642
58	ClinPharm International GmbH	Leipzig		Germany	04103
59	HNO Praxis, Bamberger Str. 7	Lichtenfels		Germany	96215
60	Dr. Dannesberger	Lorsch		Germany	64653
61	LMU München, Klinikum Großhadern	München		Germany	81377
62	Dr. Susanne Wiedemann	Nürnberg		Germany	90443
63	Instituto Biomédico de Investigación A.C.	Aguascalientes		Mexico	CP 20127
64	Hospital General de Chihuahua	Chihuahua		Mexico	C.P. 31000
65	Hospital Christus Muguerza del Parque	Chihuahua		Mexico	CP 3100
66	Clinical Research Instutute S.C.	Edo. de México		Mexico	CP 54055
67	Hospital Civil de Guadalajara "Fray Antonio Alcalde", Servicio de Otorrinolaringología; Hospital No. 278	Guadalajara Jalisco		Mexico	CP 44280
68	Grupo Médico Terranova	Guadalajara Jalisco		Mexico	CP 44630
69	Unidad de Investigación Clínica Cardiometábolica de Occidente S.C. (UNICAMO)	Jalisco		Mexico	44150
70	Hospital General de México S.S. O.D.; Servicio de Otorrinolaringología	México D.F.		Mexico	06726
71	Hospital OCA Monterrey International Research Center (MIRC)	Nuevo León		Mexico	CP 64000
72	Hospital Universitario	Nuevo León		Mexico	CP 64400
73	Unidad de Tratamientos Avanzados (UTRAV) S.C.	Nuevo León		Mexico	CP64240
74	Hospital Central "Dr. Ignacio Morones Prieto"; Servicio de Otorrinolaringología	San Luis Potosí		Mexico	78240
75	Medicentro del Parque	San Luis Potosí		Mexico	C.P. 78269
76	Unidad Médica de Especialidades del Noroeste (UMEN)	Sinaloa		Mexico	80000

Sponsors and Collaborators

• Merz Pharmaceuticals GmbH

Investigators

• Study Director: Medical Expert, Merz Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Merz Pharmaceuticals GmbH
• ClinicalTrials.gov Identifier: NCT00955799
• Other Study ID Numbers: MRZ 92579/TI/3003; 2009-011246-25
• First Posted: Aug 10, 2009
• Last Update Posted: Nov 28, 2012
• Last Verified: Nov 1, 2012

• Keywords provided by Merz Pharmaceuticals GmbH: Subjective, Tinnitus
• Additional relevant MeSH terms: Tinnitus

Study Results

No Results Posted as of Nov 28, 2012