NCT00799942

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 27, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 1, 2008

Completed
5 months until next milestone

Study Start

First participant enrolled

May 1, 2009

Completed
Last Updated

July 1, 2010

Status Verified

June 1, 2010

First QC Date

November 27, 2008

Last Update Submit

June 30, 2010

Conditions

Nystagmus, CongenitalNystagmus, AcquiredMultiple Sclerosis

Keywords

Nystagmus, congenital idiopathic

Outcome Measures

Primary Outcomes (1)

  • Long-term safety, Visual acuity

    Baseline, week 4, month 3, 6, 9, 12, 18, 24, 30, 36 and follow-up

Interventions

Neramexane mesylateDRUG

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

Eligibility Criteria

Age18 Years - 81 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients who has succesfully completed the lead-in study MRZ 92579-0707/1

You may not qualify if:

  • Occurence of any major treatment-emergent adverse event or condition during the previous protocol (MRZ 92579-0707/1)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Leicester, Leicester Royal Infirmary, Ophthalmology Group

Leicester, LE2 7LX, United Kingdom

Location

MeSH Terms

Conditions

Nystagmus, CongenitalNystagmus, PathologicMultiple Sclerosis

Condition Hierarchy (Ancestors)

Ocular Motility DisordersCranial Nerve DiseasesNervous System DiseasesEye DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDemyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 27, 2008

First Posted

December 1, 2008

Study Start

May 1, 2009

Last Updated

July 1, 2010

Record last verified: 2010-06

Locations

GB(1)