Subjective Tinnitus
Conditions
Brief summary
The purpose of this study is to investigate the safety and efficacy of neramexane mesylate in the treatment of subjective tinnitus in comparison to placebo.
Interventions
Double-blind treatment period of 17 weeks up to 75 mg Neramexane mesylate per day
DRUGPlacebo
Double-blind treatment period of 17 weeks placebo
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 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients aged 18 to 75 years with a clinical diagnosis of first onset, * Persistent (i.e. tinnitus should never be absent for \> 24 hours in a row), subjective, uni- or bilateral tinnitus present for at least 3 months but not more than 12 months
Exclusion criteria
* Clinical diagnosis of intermittent or pulsatile tinnitus * Patients who have tinnitus as a concomitant symptom of an otological/neurological disease (such as otitis media, Menière's disease, otosclerosis, etc)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| TBF-12 (Tinnitus-Beeinträchtigungs-Fragebogen-12 Tinnitus Handicap Inventory-12) total score change from baseline to end of treatment | Screening, Baseline, week 5, 13, 17 |
Secondary
| Measure | Time frame |
|---|---|
| TBF-12 factorial scores, individual responder rate, Tinnitus Rating Scale, Sleep Questionnaire, population pharmacokinetics, optional pharmacogenetics | 17 weeks |
| safety parameters | 17 weeks |
Countries
Austria, Germany, Portugal, Spain, United Kingdom
Outcome results
None listed