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

This study has been completed.
Sponsor:
Information provided by:
Merz Pharmaceuticals GmbH
ClinicalTrials.gov Identifier:
NCT00661440
First received: April 15, 2008
Last updated: November 25, 2009
Last verified: November 2009
  Purpose

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 Intervention Phase
Nystagmus, Congenital Idiopathic
Nystagmus, Acquired
Drug: Neramexane mesylate
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Merz Pharmaceuticals GmbH:

Primary Outcome Measures:
  • Visual acuity [ Time Frame: Screening, Baseline, Week 3, 7, 11, 14, 18, and Follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • nystagmus intensity, expanded nystagmus acuity function, reading ability, questionnaires, safety parameter

Estimated Enrollment: 48
Study Start Date: May 2008
Arms Assigned Interventions
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
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00661440

Locations
United Kingdom
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00661440     History of Changes
Other Study ID Numbers: MRZ 92579-0707/1, EudraCT Number 2007-002595-34
Study First Received: April 15, 2008
Last Updated: November 25, 2009
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Nystagmus, Pathologic
Nystagmus, Congenital
Ocular Motility Disorders
Cranial Nerve Diseases
Nervous System Diseases
Eye Diseases
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on July 20, 2014