A Study of Neramexane in Patients with Subjective Tinnitus

• Research type

  Research Study

• Full title

  A Randomised, Double-Blind, Placebo-Controlled, Clinical Evaluation of the Efficacy, Safety and Tolerability of Neramexane in Patients with Subjective Tinnitus

• Sponsor organisation

  Merz Pharmaceuticals GmbH

• Eudract number

  2007-007835-16

• ISRCTN Number

  N/A

• Research summary

  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 ‘ringing of the ears’. 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 patients’ 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.

• REC name

  North East - Newcastle & North Tyneside 1 Research Ethics Committee

• REC reference

  08/H0906/98

• Date of REC Opinion

  16 Oct 2008

• REC opinion

  Further Information Favourable Opinion