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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00661440
Recruitment Status : Completed
First Posted : April 18, 2008
Last Update Posted : November 26, 2009
Sponsor:
Information provided by:
Merz Pharmaceuticals GmbH

Tracking Information
First Submitted Date  ICMJE April 15, 2008
First Posted Date  ICMJE April 18, 2008
Last Update Posted Date November 26, 2009
Study Start Date  ICMJE May 2008
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: April 17, 2008)
Visual acuity [ Time Frame: Screening, Baseline, Week 3, 7, 11, 14, 18, and Follow-up ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 17, 2008)
nystagmus intensity, expanded nystagmus acuity function, reading ability, questionnaires, safety parameter
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety Study of Neramexane to Treat Congenital and Acquired Nystagmus
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Nystagmus, Congenital Idiopathic
  • Nystagmus, Acquired
Intervention  ICMJE 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
Study Arms  ICMJE
  • 1
    Intervention: Drug: Neramexane mesylate
  • 2
    Intervention: Drug: Neramexane mesylate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: April 17, 2008)
48
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00661440
Other Study ID Numbers  ICMJE MRZ 92579-0707/1
EudraCT Number 2007-002595-34
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Not Provided
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Merz Pharmaceuticals GmbH
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Irene Gottlob, Prof., MD University of Leicester, Leicester, United Kingdom
PRS Account Merz Pharmaceuticals GmbH
Verification Date November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP