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CompletedNCT00661440Updated Nov 26, 2009

Efficacy and Safety Study of Neramexane to Treat Congenital and Acquired Nystagmus

A Phase 2 interventional study of Neramexane mesylate in Nystagmus, Congenital Idiopathic and Nystagmus, Acquired, sponsored by Merz Pharmaceuticals GmbH. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2009-11-26.

Sponsored by Merz Pharmaceuticals GmbH (part of Merz Pharma) · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Nystagmus, Congenital Idiopathic
  • Nystagmus, Acquired

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03

In context

Nystagmus, Pathologic

27 studies on the registry are indexed under Nystagmus, Pathologic; 3 are open to participants now.

This study's planned enrollment of 48 is close to the median of 48 across 17 interventional studies indexed under Nystagmus, Pathologic.

Browse Nystagmus, Pathologic studies →

Lead sponsor

Merz Pharmaceuticals GmbH is the lead sponsor of 61 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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)
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
48 participants (estimated)

Study arms

  • Other
    1

    Drug: Neramexane mesylate

  • Other
    2

    Drug: Neramexane mesylate

Interventions

  • 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

06

What researchers measure

Primary outcomes

  1. Visual acuity

    Time frame: 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

07

Study locations

1 site
  • University of Leicester, Leicester Royal Infirmary, Ophthalmology Group
    Leicester, LE2 7LX, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 26, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00661440
First posted
Apr 18, 2008
Start date
May 2008
Last update
Nov 26, 2009

Study contacts

Irene Gottlob, Prof., MD
principal investigator · University of Leicester, Leicester, United Kingdom

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2009. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Neramexane mesylate

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