Efficacy, Safety and Tolerability of Neramexane in Comparison to Placebo in Patients With Subjective Tinnitus

Browse trials for

• Tinnitus 412

Tinnitus

412 studies on the registry are indexed under Tinnitus; 87 are open to participants now.

This study's planned enrollment of 400 is above the median of 60 across 339 interventional studies indexed under Tinnitus.

Lead sponsor

Merz Pharmaceuticals GmbH is the lead sponsor of 60 studies on the registry; none are open to participants now.

Study arms

• Experimental
  1

  Drug: Neramexa mesylate Double-blind treatment period of 17 weeks up to 75 mg Neramexane mesylate per day

  Drug: Neramexane mesylate

• Placebo comparator
  2

  Drug: Placebo Double-blind treatment period of 17 weeks placebo

  Drug: Placebo

Interventions

• DrugNeramexane mesylate

  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.

Primary outcomes

1. TBF-12 (Tinnitus-Beeinträchtigungs-Fragebogen-12 "Tinnitus Handycap Inventory-12") total score change from baseline to end of treatment

   Time frame: Screening, Baseline, week 5, 13, 17

Secondary outcomes

1. TBF-12 factorial scores, individual respond rate, Tinnitus Rating Scale, Sleep Questionnaire, Qualitiy Of Life, population pharmacokinetics, optional pharmacogenetics

   Time frame: 29 weeks

2. safety parameters

   Time frame: 29 weeks