Neramexane for Tinnitus

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

Tinnitus is commonly referred to as "ringing of the ears" - the perception of sounds in the absence of an external source of acoustic signals. Tinnitus may represent a severe disease and symptoms include depression, sleeping difficulties, decreased sound tolerance and hearing loss. One hypothesis is that tinnitus is caused by an increased activity of NMDA glutamate and dysfunctional alpha9/alpha10 acetylcholine receptors in the inner ear and central nervous system. Neramexane may alleviate tinnitus symptoms due to its NMDA and alpha9/alpha10 nACh receptor blocking activity. The purpose of this study is to assess the safety and efficacy of Neramexane compared with placebo in patients with subjective tinnitus.

Condition or disease	Intervention/treatment	Phase
Tinnitus	Drug: Neramexane; Drug: Placebo	Phase 2

Study Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	431 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	A Randomised, Double-Blind, Placebo-Controlled, Clinical Dose-Ranging Trial to Evaluate Efficacy and Safety of a NMDA Antagonist for Oral Administration in Patients With Subjective Tinnitus
Study Start Date :	October 2005
Actual Primary Completion Date :	March 2007
Actual Study Completion Date :	March 2007

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: Neramexane 25mg/d	Drug: Neramexane; Oral tablets, duration: 16 weeks
Experimental: Neramexane 50mg/d	Drug: Neramexane; Oral tablets, duration: 16 weeks
Experimental: Neramexane 75mg/d	Drug: Neramexane; Oral tablets, duration: 16 weeks
Placebo Comparator: Placebo	Drug: Placebo; Oral tablets, duration: 16 weeks

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Change from baseline in tinnitus severity at the endpoint visit [ Time Frame: Week 16 ]
2. Comparison of adverse events (type, severity, seriousness, frequency, relatedness) between treatment arms [ Time Frame: From baseline until week 20 ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 65 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• main inclusion criterion: persistent, subjective, uni- or bilateral tinnitus

Exclusion Criteria:

• main exclusion criterion: intermittent or pulsatile tinnitus

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Austria
Vienna, Austria
Germany
Munich, Germany

Sponsors and Collaborators

Merz Pharmaceuticals GmbH

Investigators

Study Chair:	Markus Suckfüll, MD PhD Ass. Prof.	Ludwig-Maximilians - University of Munich

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications of Results:

Suckfüll M, Althaus M, Ellers-Lenz B, Gebauer A, Görtelmeyer R, Jastreboff PJ, Moebius HJ, Rosenberg T, Russ H, Wirth Y, Krueger H. A randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of neramexane in patients with moderate to severe subjective tinnitus. BMC Ear Nose Throat Disord. 2011 Jan 11;11:1. doi: 10.1186/1472-6815-11-1.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Görtelmeyer R, Schmidt J, Suckfüll M, Jastreboff P, Gebauer A, Krüger H, Wittmann W. Assessment of tinnitus-related impairments and disabilities using the German THI-12: sensitivity and stability of the scale over time. Int J Audiol. 2011 Aug;50(8):523-9. doi: 10.3109/14992027.2011.578591.

Responsible Party:	Dr. Matthias Zerm, Manager Public Disclosure, Merz Pharmaceuticals GmbH
ClinicalTrials.gov Identifier:	NCT00405886 History of Changes
Other Study ID Numbers:	MRZ 92579-0508/1
First Posted:	November 30, 2006
Last Update Posted:	March 11, 2011
Last Verified:	March 2011

Additional relevant MeSH terms:

Tinnitus; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases	Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms