Clincosm LogoSign in Get a demo

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

Sponsor
Merz Pharmaceuticals GmbH (Industry)
Overall Status
Completed
CT.gov ID
NCT00661440
Collaborator
(none)
48
Enrollment
1
Location
2
Arms

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Neramexane mesylate
 Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
48 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official 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
Study Start Date :
May 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Other: 1

Drug: Neramexane mesylate
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

    		•
    Other: 2

    Drug: Neramexane mesylate
    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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Visual acuity [Screening, Baseline, Week 3, 7, 11, 14, 18, and Follow-up]

    Secondary Outcome Measures

    1. nystagmus intensity, expanded nystagmus acuity function, reading ability, questionnaires, safety parameter []

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Leicester, Leicester Royal Infirmary, Ophthalmology Group Leicester United Kingdom LE2 7LX

    Sponsors and Collaborators

    • Merz Pharmaceuticals GmbH

    Investigators

    • Principal Investigator: Irene Gottlob, Prof., MD, University of Leicester, Leicester, United Kingdom

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00661440
    Other Study ID Numbers:
    • MRZ 92579-0707/1
    • EudraCT Number 2007-002595-34
    First Posted:
    Apr 18, 2008
    Last Update Posted:
    Nov 26, 2009
    Last Verified:
    Nov 1, 2009
    Additional relevant MeSH terms:
    Nystagmus, Pathologic
    Nystagmus, Congenital

    Study Results

    No Results Posted as of Nov 26, 2009