Neramexane for Tinnitus

Merz Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Tinnitus

Treatments: Drug: Placebo; Drug: Neramexane

Study type: Interventional

Funder types: Industry

Identifiers

NCT00405886

MRZ 92579-0508/1

Details and patient eligibility

About

Tinnitus is commonly referred to as "ringing of the ears" - the perception of sounds in the absence of an external source of acoustic signals. Tinnitus may represent a severe disease and symptoms include depression, sleeping difficulties, decreased sound tolerance and hearing loss. One hypothesis is that tinnitus is caused by an increased activity of NMDA glutamate and dysfunctional alpha9/alpha10 acetylcholine receptors in the inner ear and central nervous system. Neramexane may alleviate tinnitus symptoms due to its NMDA and alpha9/alpha10 nACh receptor blocking activity. The purpose of this study is to assess the safety and efficacy of Neramexane compared with placebo in patients with subjective tinnitus.

Enrollment: 431 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• main inclusion criterion: persistent, subjective, uni- or bilateral tinnitus

Exclusion criteria

• main exclusion criterion: intermittent or pulsatile tinnitus

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

431 participants in 4 patient groups, including a placebo group

Neramexane 25mg/d

Experimental group

Treatment:

Drug: Neramexane

Neramexane 50mg/d

Experimental group

Treatment:

Drug: Neramexane

Neramexane 75mg/d

Experimental group

Treatment:

Drug: Neramexane

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo