Neramexane for Tinnitus
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
1 other identifier
interventional
431
2 countries
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2005
Shorter than P25 for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2005
CompletedFirst Submitted
Initial submission to the registry
November 29, 2006
CompletedFirst Posted
Study publicly available on registry
November 30, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2007
CompletedMarch 11, 2011
March 1, 2011
1.4 years
November 29, 2006
March 10, 2011
Conditions
Outcome Measures
Primary Outcomes (2)
Change from baseline in tinnitus severity at the endpoint visit
Week 16
Comparison of adverse events (type, severity, seriousness, frequency, relatedness) between treatment arms
From baseline until week 20
Study Arms (4)
Neramexane 25mg/d
EXPERIMENTALNeramexane 50mg/d
EXPERIMENTALNeramexane 75mg/d
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Unknown Facility
Vienna, Austria
Unknown Facility
Munich, Germany
Related Publications (2)
Suckfull M, Althaus M, Ellers-Lenz B, Gebauer A, Gortelmeyer 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.
PMID: 21223542RESULTGortelmeyer R, Schmidt J, Suckfull M, Jastreboff P, Gebauer A, Kruger 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.
PMID: 21751942DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Markus Suckfüll, MD PhD Ass. Prof.
Ludwig-Maximilians - University of Munich
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 29, 2006
First Posted
November 30, 2006
Study Start
October 1, 2005
Primary Completion
March 1, 2007
Study Completion
March 1, 2007
Last Updated
March 11, 2011
Record last verified: 2011-03