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

Phase 1

• Conditions: congenital idiopathic nystagmus and aquired nystagmus; MedDRA version: 9.1 Level: LLT Classification code 10029864 Term: Nystagmus; MedDRA version: 9.1 Level: LLT Classification code 10029867 Term: Nystagmus congenital

• Registration Number: EUCTR2007-007663-25-GB
• Lead Sponsor: Merz Pharmaceuticals GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-10-03
• Study Completion: 2010-06-10
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 48

Inclusion Criteria

•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

Exclusion Criteria

•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:

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The main purpose of the study is to evaluate the long-term safety and tolerability of daily doses of 25, 50, or 75 mg neramexane mesylate in the treatment of congenital idiopathic nystagmus or nystagmus secondary to multiple sclerosis. The study will also investigate the permanence of visual acuity improvement (long-term efficacy).;Secondary Objective: ;Primary end point(s): The primary objective of this open-label, extension study is to evaluate the long-term safety and tolerability of daily doses of 25, 50, or 75 mg neramexane mesylate in the treatment of CIN or nystagmus secondary to multiple sclerosis. A further objective of the trial will be to investigate the permanence of visual acuity improvement.