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NCT00799942 Clinical Trial

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

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00799942
Other study ID # MRZ 92579-0738/1
Secondary ID 2007-007663-25
Status Terminated
Phase Phase 2
First received November 27, 2008
Last updated June 30, 2010
Start date May 2009

Study information
Verified date June 2010
Source Merz Pharmaceuticals GmbH
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Medicines and Healthcare Products Regulatory Agency
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
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)

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Neramexane mesylate
open-label treatment of 36 months Neramexane mesylate up to 75 mg per day

Locations
Country Name City State
United Kingdom University of Leicester, Leicester Royal Infirmary, Ophthalmology Group Leicester

Sponsors (1)
Lead Sponsor Collaborator
Merz Pharmaceuticals GmbH

Country where clinical trial is conducted

United Kingdom, 

Outcome
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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