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, 12 weeks follow-up.
DRUGPlacebo
Double-blind treatment period of 17 weeks placebo, 12 weeks follow-up.
Sponsors
Merz Pharmaceuticals GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, 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 sghould never be absent for \>24 hours in a row), subjective, uni-or bilateral tinntius 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, Meniére´s disease, otosclerosis, etc.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| TBF-12 (Tinnitus-Beeinträchtigungs-Fragebogen-12 Tinnitus Handycap 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 respond rate, Tinnitus Rating Scale, Sleep Questionnaire, Qualitiy Of Life, population pharmacokinetics, optional pharmacogenetics | 29 weeks |
| safety parameters | 29 weeks |
Countries
Belgium, Czechia, France, Netherlands, Poland, South Africa
Outcome results
None listed