Neramexane for Tinnitus - Full Text View

Purpose

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	Intervention	Phase
Tinnitus	Drug: Neramexane Drug: Placebo	Phase 2


Study Type:	Interventional
Study Design:	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

Resource links provided by NLM:

MedlinePlus related topics: Tinnitus

U.S. FDA Resources

Further study details as provided by Merz Pharmaceuticals GmbH:

Primary Outcome Measures:

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


Enrollment:	431
Study Start Date:	October 2005
Study Completion Date:	March 2007
Primary Completion Date:	March 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility


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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00405886

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

Publications:

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
Study First Received:	November 29, 2006
Last Updated:	March 10, 2011

Additional relevant MeSH terms:


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

ClinicalTrials.gov processed this record on August 23, 2017