Neramexane for Tinnitus

Merz Pharmaceuticals GmbH431 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

431

Conditions

Tinnitus

Interventions

NeramexaneDRUG

Oral tablets, duration: 16 weeks

PlaceboDRUG

Oral tablets, duration: 16 weeks

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * main inclusion criterion: persistent, subjective, uni- or bilateral tinnitus Exclusion Criteria: * main exclusion criterion: intermittent or pulsatile tinnitus

Locations (2)

Unnamed facility

Vienna, Austria

Unnamed facility

Munich, Germany

Outcomes

Primary Outcomes

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

Data from ClinicalTrials.gov

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