Open-lable Extension Study on Safety and Efficacy of Neramexane to Treat Congenital and Acquired Nystagmus

Phase 2

Terminated

• Conditions: Nystagmus, Congenital; Nystagmus, Acquired; Multiple Sclerosis

• Registration Number: NCT00799942
• Lead Sponsor: Merz Pharmaceuticals GmbH

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-11-27
• Study First Submitted QC: 2008-11-28
• Study First Posted: 2008-12-01
• Study Start: 2009-05
• Status Verified: 2010-06
• Last Update Submitted: 2010-06-30
• Last Update Posted: 2010-07-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

• patients who has succesfully completed the lead-in study MRZ 92579-0707/1

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Exclusion Criteria

• Occurence of any major treatment-emergent adverse event or condition during the previous protocol (MRZ 92579-0707/1)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Long-term safety, Visual acuity	Baseline, week 4, month 3, 6, 9, 12, 18, 24, 30, 36 and follow-up

Trial Locations

Locations (1)

University of Leicester, Leicester Royal Infirmary, Ophthalmology Group; 🇬🇧 Leicester, United Kingdom