Neramexane for Tinnitus

Tinnitus Clinical Trial

Official title:

A Randomised, Double-Blind, Placebo-Controlled, Clinical Dose-Ranging Trial to Evaluate Efficacy and Safety of a NMDA Antagonist for Oral Administration in Patients With Subjective Tinnitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00405886
• Other study ID #: MRZ 92579-0508/1
• Status: Completed
• Phase: Phase 2
• First received: November 29, 2006
• Last updated: March 10, 2011
• Start date: October 2005
• Est. completion date: March 2007

Study information

• Verified date: March 2011
• Source: Merz Pharmaceuticals GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 431
• Est. completion date: March 2007
• Est. primary completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• main exclusion criterion: intermittent or pulsatile tinnitus

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tinnitus

Intervention

Drug:
• Neramexane
Oral tablets, duration: 16 weeks
• Placebo
Oral tablets, duration: 16 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merz Pharmaceuticals GmbH

Countries where clinical trial is conducted

Austria,  Germany, 

References & Publications (1)

Suckfüll M, Althaus M, Ellers-Lenz B, Gebauer A, Görtelmeyer 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in tinnitus severity at the endpoint visit		Week 16	No
Primary	Comparison of adverse events (type, severity, seriousness, frequency, relatedness) between treatment arms		From baseline until week 20	Yes