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Clinical Trials/NCT00405886
NCT00405886
Completed
Phase 2

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

Merz Pharmaceuticals GmbH0 sites431 target enrollmentOctober 2005
ConditionsTinnitus
InterventionsNeramexanePlacebo

Overview

Phase
Phase 2
Intervention
Neramexane
Conditions
Tinnitus
Sponsor
Merz Pharmaceuticals GmbH
Enrollment
431
Primary Endpoint
Comparison of adverse events (type, severity, seriousness, frequency, relatedness) between treatment arms
Status
Completed
Last Updated
15 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2005
End Date
March 2007
Last Updated
15 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • main exclusion criterion: intermittent or pulsatile tinnitus

Arms & Interventions

Neramexane 25mg/d

Intervention: Neramexane

Neramexane 50mg/d

Intervention: Neramexane

Neramexane 75mg/d

Intervention: Neramexane

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

Comparison of adverse events (type, severity, seriousness, frequency, relatedness) between treatment arms

Time Frame: From baseline until week 20

Change from baseline in tinnitus severity at the endpoint visit

Time Frame: Week 16

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