Efficacy, Safety, Tolerability of Neramexane in Patients With Subjective Tinnitus

Merz Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Subjective Tinnitus

Treatments: Drug: Placebo; Drug: Neramexane mesylate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00955799

MRZ 92579/TI/3003

2009-011246-25 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 455 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Main Inclusion Criteria:

• Patients aged between 18 and 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 subacute tinnitus

Main 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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455 participants in 2 patient groups, including a placebo group

Neramexane mesylate

Experimental group

Description:

Double-blind treatment period of 29 weeks up to 75 mg Neramexane mesylate per day

Treatment:

Drug: Neramexane mesylate

Placebo

Placebo Comparator group

Description:

Placebo: identical placebo tablets

Treatment:

Drug: Placebo