Back to resultsOpen-lable Extension Study on Safety and Efficacy of Neramexane to Treat Congenital and Acquired Nystagmus
Primary Purpose
Nystagmus, Congenital, Nystagmus, Acquired, Multiple Sclerosis
Status
Terminated
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
Neramexane mesylate
Sponsored by
About this trial
This is an interventional treatment trial for Nystagmus, Congenital focused on measuring Nystagmus, congenital idiopathic
Eligibility Criteria
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)
Sites / Locations
- University of Leicester, Leicester Royal Infirmary, Ophthalmology Group
Outcomes
Primary Outcome Measures
Long-term safety, Visual acuity
Secondary Outcome Measures
Full Information
NCT ID
NCT00799942
First Posted
November 27, 2008
Last Updated
June 30, 2010
Sponsor
Merz Pharmaceuticals GmbH
1. Study Identification
Unique Protocol Identification Number
NCT00799942
Brief Title
Open-lable Extension Study on Safety and Efficacy of Neramexane to Treat Congenital and Acquired Nystagmus
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2010
Overall Recruitment Status
Terminated
Study Start Date
May 2009 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Merz Pharmaceuticals GmbH
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nystagmus, Congenital, Nystagmus, Acquired, Multiple Sclerosis
Keywords
Nystagmus, congenital idiopathic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
48 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Neramexane mesylate
Intervention Description
open-label treatment of 36 months Neramexane mesylate up to 75 mg per day
Primary Outcome Measure Information:
Title
Long-term safety, Visual acuity
Time Frame
Baseline, week 4, month 3, 6, 9, 12, 18, 24, 30, 36 and follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
81 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
University of Leicester, Leicester Royal Infirmary, Ophthalmology Group
City
Leicester
ZIP/Postal Code
LE2 7LX
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Open-lable Extension Study on Safety and Efficacy of Neramexane to Treat Congenital and Acquired Nystagmus
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