Tinnitus
Conditions
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.
Interventions
DRUGNeramexane
Oral tablets, duration: 16 weeks
DRUGPlacebo
Oral tablets, duration: 16 weeks
Sponsors
Merz Pharmaceuticals GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* main inclusion criterion: persistent, subjective, uni- or bilateral tinnitus
Exclusion criteria
* main exclusion criterion: intermittent or pulsatile tinnitus
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Austria, Germany
Outcome results
None listed