Efficacy, Safety and Tolerability of Neramexane in Comparison to Placebo 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

NCT00772980

MRZ 92579/TI/3002

EudraCT Number 2008-000639-16

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: 400 estimated 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 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.)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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400 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

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

Treatment:

Drug: Neramexane mesylate

2

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo