Trials / Completed
CompletedNCT00405886
Neramexane for Tinnitus
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 431 (actual)
- Sponsor
- Merz Pharmaceuticals GmbH · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Neramexane | Oral tablets, duration: 16 weeks |
| DRUG | Placebo | Oral tablets, duration: 16 weeks |
Timeline
- Start date
- 2005-10-01
- Primary completion
- 2007-03-01
- Completion
- 2007-03-01
- First posted
- 2006-11-30
- Last updated
- 2011-03-11
Locations
2 sites across 2 countries: Austria, Germany
Source: ClinicalTrials.gov record NCT00405886. Inclusion in this directory is not an endorsement.