Neramexane for Tinnitus

NCT ID: NCT00405886

Last Updated: 2011-03-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

431 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2007-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Tinnitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Neramexane 25mg/d

Group Type EXPERIMENTAL

Neramexane

Intervention Type DRUG

Oral tablets, duration: 16 weeks

Neramexane 50mg/d

Group Type EXPERIMENTAL

Neramexane

Intervention Type DRUG

Oral tablets, duration: 16 weeks

Neramexane 75mg/d

Group Type EXPERIMENTAL

Neramexane

Intervention Type DRUG

Oral tablets, duration: 16 weeks

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Oral tablets, duration: 16 weeks

Interventions

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Neramexane

Oral tablets, duration: 16 weeks

Intervention Type DRUG

Placebo

Oral tablets, duration: 16 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* main exclusion criterion: intermittent or pulsatile tinnitus
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merz Pharmaceuticals GmbH

INDUSTRY

Sponsor Role lead

Responsible Party

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Merz Pharmaceuticals GmbH

Principal Investigators

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Markus Suckfüll, MD PhD Ass. Prof.

Role: STUDY_CHAIR

Ludwig-Maximilians - University of Munich

Locations

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Vienna, , Austria

Site Status

Munich, , Germany

Site Status

Countries

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Austria Germany

References

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Suckfull M, Althaus M, Ellers-Lenz B, Gebauer A, Gortelmeyer R, Jastreboff PJ, Moebius HJ, Rosenberg T, Russ H, Wirth Y, Krueger H. A randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of neramexane in patients with moderate to severe subjective tinnitus. BMC Ear Nose Throat Disord. 2011 Jan 11;11:1. doi: 10.1186/1472-6815-11-1.

Reference Type RESULT
PMID: 21223542 (View on PubMed)

Gortelmeyer R, Schmidt J, Suckfull M, Jastreboff P, Gebauer A, Kruger H, Wittmann W. Assessment of tinnitus-related impairments and disabilities using the German THI-12: sensitivity and stability of the scale over time. Int J Audiol. 2011 Aug;50(8):523-9. doi: 10.3109/14992027.2011.578591.

Reference Type DERIVED
PMID: 21751942 (View on PubMed)

Other Identifiers

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MRZ 92579-0508/1

Identifier Type: -

Identifier Source: org_study_id

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