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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00799942
Recruitment Status : Terminated
First Posted : December 1, 2008
Last Update Posted : July 1, 2010
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Nystagmus, Congenital Nystagmus, Acquired Multiple Sclerosis Drug: Neramexane mesylate Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : May 2009

Resource links provided by the National Library of Medicine



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


Primary Outcome Measures :
  1. Long-term safety, Visual acuity [ Time Frame: Baseline, week 4, month 3, 6, 9, 12, 18, 24, 30, 36 and follow-up ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 81 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00799942


Locations
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United Kingdom
University of Leicester, Leicester Royal Infirmary, Ophthalmology Group
Leicester, United Kingdom, LE2 7LX
Sponsors and Collaborators
Merz Pharmaceuticals GmbH
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ClinicalTrials.gov Identifier: NCT00799942    
Other Study ID Numbers: MRZ 92579-0738/1
2007-007663-25
First Posted: December 1, 2008    Key Record Dates
Last Update Posted: July 1, 2010
Last Verified: June 2010
Keywords provided by Merz Pharmaceuticals GmbH:
Nystagmus, congenital idiopathic
Additional relevant MeSH terms:
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Multiple Sclerosis
Nystagmus, Pathologic
Nystagmus, Congenital
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Ocular Motility Disorders
Cranial Nerve Diseases
Eye Diseases
Infant, Newborn, Diseases