Trial | NCT00405886  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    neramexane ...

  • Study Participants

    431
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.
Study Started
Oct 31
2005
Primary Completion
Mar 31
2007
Study Completion
Mar 31
2007
Last Update
Mar 11
2011
Estimate

Drug Neramexane

Oral tablets, duration: 16 weeks

Drug Placebo

Oral tablets, duration: 16 weeks

Neramexane 25mg/d Experimental

Neramexane 50mg/d Experimental

Neramexane 75mg/d Experimental

Placebo Placebo Comparator

Criteria 

Inclusion Criteria:

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

Exclusion Criteria:

main exclusion criterion: intermittent or pulsatile tinnitus
No Results Posted