NCT00661440

Brief Summary

The purpose of this study is to investigate the safety and efficacy of neramexane mesylate in the treatment of congenital idiopathic nystagmus (CIN) in comparison to placebo. In addition, a subgroup of multiple sclerosis (MS) patients suffering from acquired nystagmus will be included; this subgroup will be analyzed in an exploratory manner only.

Trial Health

80
On Track

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
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 15, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 18, 2008

Completed
13 days until next milestone

Study Start

First participant enrolled

May 1, 2008

Completed
Last Updated

November 26, 2009

Status Verified

November 1, 2009

First QC Date

April 15, 2008

Last Update Submit

November 25, 2009

Conditions

Nystagmus, Congenital IdiopathicNystagmus, Acquired

Outcome Measures

Primary Outcomes (1)

  • Visual acuity

    Screening, Baseline, Week 3, 7, 11, 14, 18, and Follow-up

Secondary Outcomes (1)

  • nystagmus intensity, expanded nystagmus acuity function, reading ability, questionnaires, safety parameter

Study Arms (2)

1

OTHER
Drug: Neramexane mesylate

2

OTHER
Drug: Neramexane mesylate

Interventions

Neramexane mesylateDRUG

2 double-blind, cross-over treatment periods of 7 weeks separated by a wash-out phase, up to 75 mg Neramexane mesylate per day

Also known as: - verum, placebo, - placebo, verum
12

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with congenital idiopathic nystagmus or acquired nystagmus subsequent to multiple sclerosis
  • male or female outpatients
  • aged between 18 and 80 years (inclusive) at screening

You may not qualify if:

  • patients with evidence of neurologic disorders other than CIN such as congenital nystagmus due to albinism or retinal diseases and/or acquired nystagmus (exemption: secondary to MS)

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, Pathologic

Condition Hierarchy (Ancestors)

Ocular Motility DisordersCranial Nerve DiseasesNervous System DiseasesEye Diseases

Study Officials

  • Irene Gottlob, Prof., MD

    University of Leicester, Leicester, United Kingdom

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 15, 2008

First Posted

April 18, 2008

Study Start

May 1, 2008

Last Updated

November 26, 2009

Record last verified: 2009-11

Locations

GB(1)