A Study of Neramexane in Patients with Subjective Tinnitus
A Randomised, Double-Blind, Placebo-Controlled, Clinical Evaluation of the Efficacy, Safety and Tolerability of Neramexane in Patients with Subjective Tinnitus
Merz Pharmaceuticals GmbH
This study has been designed to assess the effectiveness, safety and tolerability of an investigational drug, Neramexane in patients with Subjective Tinnitus. Tinnitus is commonly referred to as â€˜ringing of the earsâ€™. For the individual patient, tinnitus may be tolerable or it may represent a debilitating illness. So far, there are no well-established, specific medical treatments for tinnitus but the results from previous clinical studies have led to the decision to further investigate neramexane in tinnitus. The study is being sponsored by Merz Pharmaceuticals. It will be conducted in approximately 65 sites in Germany, Austria, United Kingdom, Spain, and Portugal. Approximately 400 patients will be randomised (put by chance) into 2 groups on a 1:1 basis. Patients in one group will receive the study drug, patients in the other group will receive placebo ( a dummy drug that contains no active ingredient). The study consists of a 1-day to 4-week screening period (to check patientsâ€™ eligibility to participate) and a 17-week treatment period (with neramexane or placebo). During this treatment period the participants will undergo the following study procedures: medical history recorded, blood pressure and pulse rate recorded, body weight measured, physical examinations, audiology/psychoacoustic measures recorded,12-lead electrocardiograms, blood samples taken for laboratory safety tests, pharmacokinetic sampling, pharmacokinetic testing, pregnancy testing (if applicable), and urine samples for urinalysis. Several questionnaires will also be completed throughout the study. Patients who have completed this study will be offered participation in an extension study.
North East - Newcastle & North Tyneside 1 Research Ethics Committee
Date of REC Opinion
16 Oct 2008
Further Information Favourable Opinion