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

This study is not yet open for participant recruitment.

Verified by Merz Pharmaceuticals GmbH, November 2008

Sponsored by:	Merz Pharmaceuticals GmbH
Information provided by:	Merz Pharmaceuticals GmbH
ClinicalTrials.gov Identifier:	NCT00799942

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 II

MedlinePlus related topics: Multiple Sclerosis

Drug Information available for: Neramexane Neramexane Mesylate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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

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:

Intervention Details:

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

Study ID Numbers:	MRZ 92579-0738/1, 2007-007663-25
Study First Received:	November 27, 2008
Last Updated:	November 28, 2008
ClinicalTrials.gov Identifier:	NCT00799942
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Merz Pharmaceuticals GmbH:

Nystagmus, congenital idiopathic

Study placed in the following topic categories:

Motor neuro-ophthalmic disorders
Nystagmus, Congenital
Autoimmune Diseases
Demyelinating Diseases
Eye Diseases
Sclerosis
Demyelinating diseases

Ocular motility disorders
Nystagmus, Pathologic
Ocular Motility Disorders
Multiple Sclerosis
Demyelinating Autoimmune Diseases, CNS
Infant, Newborn, Diseases
Autoimmune Diseases of the Nervous System

Additional relevant MeSH terms:

Pathologic Processes
Immune System Diseases
Nervous System Diseases
Cranial Nerve Diseases

ClinicalTrials.gov processed this record on January 16, 2009