NCT00799942TerminatedPhase 2
Long-term Open-label Extension Study to Assess the Safety, Tolerability, and Efficacy of Neramexane Mesylate in Congenital Idiopathic Nystagmus and Acquired Nystagmus
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Sponsor
- Merz Pharmaceuticals GmbH
- Enrollment
- 48
- Locations
- 2
- Primary Endpoint
- Long-term safety, Visual acuity
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 81 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Outcomes
Primary Outcomes
Long-term safety, Visual acuity
Time Frame: Baseline, week 4, month 3, 6, 9, 12, 18, 24, 30, 36 and follow-up
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (2)
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