Multiple Sclerosis Clinical Trial
Official title:
Long-term Open-label Extension Study to Assess the Safety, Tolerability, and Efficacy of Neramexane Mesylate in Congenital Idiopathic Nystagmus and Acquired Nystagmus
The purpose of this study is to investigate the long-term safety, tolerability and efficacy of neramexane mesylate in the treatment of congenital idiopathic nystagmus (CIN). In addition, a subgroup of multiple sclerosis (MS) patients suffering from acquired nystagmus will be included.
Status | Terminated |
Enrollment | 48 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 81 Years |
Eligibility |
Inclusion Criteria: - patients who has succesfully completed the lead-in study MRZ 92579-0707/1 Exclusion Criteria: - Occurence of any major treatment-emergent adverse event or condition during the previous protocol (MRZ 92579-0707/1) |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United Kingdom | University of Leicester, Leicester Royal Infirmary, Ophthalmology Group | Leicester |
Lead Sponsor | Collaborator |
---|---|
Merz Pharmaceuticals GmbH |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Long-term safety, Visual acuity | Baseline, week 4, month 3, 6, 9, 12, 18, 24, 30, 36 and follow-up | No |
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