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

NCT ID: NCT00799942

Last Updated: 2010-07-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Brief Summary

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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

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Conditions

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Nystagmus, Congenital Nystagmus, Acquired Multiple Sclerosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Neramexane mesylate

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

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

81 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merz Pharmaceuticals GmbH

INDUSTRY

Sponsor Role lead

Locations

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University of Leicester, Leicester Royal Infirmary, Ophthalmology Group

Leicester, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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2007-007663-25

Identifier Type: -

Identifier Source: secondary_id

MRZ 92579-0738/1

Identifier Type: -

Identifier Source: org_study_id

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