Text Size

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

This study has been terminated.
Sponsor:
Information provided by:
Merz Pharmaceuticals GmbH
ClinicalTrials.gov Identifier:
NCT00799942
First received: November 27, 2008
Last updated: June 30, 2010
Last verified: June 2010
History of Changes
  Purpose

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 Intervention Phase
Nystagmus, Congenital
Nystagmus, Acquired
Multiple Sclerosis
 Drug: Neramexane mesylate
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Merz Pharmaceuticals GmbH:

Primary Outcome Measures:
  • Long-term safety, Visual acuity [ Time Frame: Baseline, week 4, month 3, 6, 9, 12, 18, 24, 30, 36 and follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment: 48
Study Start Date: May 2009
Intervention Details:
    Drug: Neramexane mesylate
    open-label treatment of 36 months Neramexane mesylate up to 75 mg per day
  Eligibility

Ages Eligible for Study:   18 Years to 81 Years
Genders Eligible for Study:   Both
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00799942

Locations
United Kingdom
University of Leicester, Leicester Royal Infirmary, Ophthalmology Group
Leicester, United Kingdom, LE2 7LX
Sponsors and Collaborators
Merz Pharmaceuticals GmbH
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00799942     History of Changes
Other Study ID Numbers: MRZ 92579-0738/1, 2007-007663-25
Study First Received: November 27, 2008
Last Updated: June 30, 2010
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Merz Pharmaceuticals GmbH:
Nystagmus, congenital idiopathic

Additional relevant MeSH terms:
Multiple Sclerosis
Nystagmus, Pathologic
Nystagmus, Congenital
Sclerosis
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
Pathologic Processes

ClinicalTrials.gov processed this record on May 21, 2013