Efficacy, Safety and Tolerability of Neramexane in Patients With Subjective Tinnitus (EASE)

Merz Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Subjective Tinnitus

Treatments: Drug: Neramexane mesylate; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00739635

MRZ 92579/TI/3001

EudraCT Number 2007-007835-16

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: 411 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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411 participants in 2 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: Neramexane mesylate

2

Placebo Comparator group

Treatment:

Drug: Placebo