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
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.
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