Long-Term Study of Neramexane in Patients with Subjective Tinnitus
Research type
Research Study
Full title
An Open-Label, Long-Term Treatment Study to Assess the Long-Term Safety and Tolerability and Efficacy of Neramexane in Patients with Subjective Tinnitus
Sponsor organisation
Merz Pharmaceuticals GmbH
Eudract number
2008-001432-13
ISRCTN Number
N/A
Research summary
This study is a long-term treatment study to assess the long-term safety,tolerability and effectiveness of an investigational drug, Neramexane, in patients with subjective tinnitus. This study is a follow-on study to a previous study involving Neramexane. Tinnitus is commonly referred to as ??ringing of the ears?Â. 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. This study is being sponsored by Merz Pharmaceuticals GmbH. It will be conducted in approximately 195 centres across Europe and involve approximately 80 patients in the UK. All participants will receive the study drug, Neramexane.The study consists of a four- or five-week up-titration (dose increase) period (depending on the target study drug dose), and a 12-month fixed-dose treatment period with twice daily dosing according to body weight. During this 12-month period participants will return to the site for four visits during which they will undergo the following study procedures: medical history recorded, blood pressure and pulse rate recorded, body weight measured, 12-lead Electrocardiograms, blood samples taken for clinical chemistry, haematology & coagulation, and urine samples for urinalysis and pregnancy testing (if applicable). Two questionnaires and one interview will also be completed/conducted throughout the study
REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
08/H0906/125
Date of REC Opinion
10 Dec 2008
REC opinion
Further Information Favourable Opinion