A Long-Term Open Label Extension Study to assess the Safety, Tolerability, and Efficacy of Neramexane Mesylate in Congenital Idiopathic Nystagmus and Acquired Nystagmus.

Merz Pharmaceuticals GmbH0 个研究点目标入组 48 人开始时间: 2008年10月3日最近更新: 2019年12月10日

研究概览

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•Male or female patients between 18 and 81 years (inclusive) of age who have successfully completed both study periods in the previous double-blind protocol MRZ 92579 0707/1 and who have been deemed eligible (had a response to treatment) in the judgment of the Investigator;
•Patient fulfilled, at entry into the double-blind study, the diagnostic criteria for congenital idiopathic nystagmus (CIN) or nystagmus secondary to multiple sclerosis (MS);
•Patient has been properly informed of the nature and risks of the study and has given written informed consent prior to entering the study;
•12 lead electrocardiogram (ECG) without clinically significant abnormalities at baseline;
•Able and willing to comply with instructions during the outpatient periods;
•For females of childbearing potential (last menses less than one year prior to enrolment): negative pregnancy test at baseline (i.e. prior to entry in the double-blind treatment phase); not breast-feeding; either surgically sterile or agreement to use a medically accepted, highly effective contraception during the entire duration of the study.
•Multiple sclerosis patients only:
•‘multiple sclerosis’ patients must be neurologically stable with no evidence of acute relapse.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•Occurrence of any major treatment-emergent adverse event or condition during the previous protocol (MRZ 92579 0707/1) that, in the opinion of the Investigator, should exclude the patient from participating in the open label extension;
•Patients with a clinically significant medical or surgical condition at baseline which might compromise the hematologic, cardiovascular, pulmonary, renal, gastrointestinal, or hepatic system or other conditions / abnormalities of sufficient severity that would preclude safe enrollment in the study or interfere with their participation in the study (e.g. psychiatric disorder);
•Patients with arterial hypertension (systolic blood pressure greater than 180 mmHg or less than 90 mmHg), or hypotension (diastolic blood pressure greater than 105 mmHg or less than 50 mmHg) at baseline;
•Patients with known hypersensitivity or intolerance to neramexane, amantadine, or memantine;
•Patients with known or suspected alcoholism or drug abuse
•Patients requiring concomitant treatment with any prohibited prescription or over-the-counter medication (Appendix 11.1);
•Relevant non-compliance issue(s) in the previous protocol or a history of chronic non-compliance with drug regimens;
•Patients who, in the judgment of the Investigator, might not be suitable for enrollment into the study.
•Multiple sclerosis patients only:

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