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Completed

NCT Number: NCT00661440

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

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.

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Key information

Conditions

Nystagmus, Congenital Idiopathic Cranial Nerve Diseases Eye Diseases Nervous System Diseases Nystagmus, Acquired Nystagmus, Pathologic Ocular Motility Disorders

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Leicester, Leicester Royal Infirmary, Ophthalmology Group

Leicester, LE2 7LX, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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)

Treatment and study plan

Neramexane mesylate

Drug

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

Other names: - verum, placebo, - placebo, verum

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

Sponsors and collaborators

Lead sponsor

Merz Pharmaceuticals GmbH

Industry

Registry information

Official study title

Efficacy and Safety of Neramexane Mesylate in Congenital Idiopathic Nystagmus and Acquired Nystagmus: a Randomized, Double-blind, Placebo-controlled, Single Center, Proof of Concept Study Using a Two-period Cross-over Design

Important dates

Study start
2008
First posted
Apr 18, 2008
Registry last updated
Nov 26, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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