Back to resultsEfficacy and Safety Study of Neramexane to Treat Congenital and Acquired Nystagmus
Primary Purpose
Nystagmus, Congenital Idiopathic, Nystagmus, Acquired
Status
Completed
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
Neramexane mesylate
Sponsored by
About this trial
This is an interventional treatment trial for Nystagmus, Congenital Idiopathic
Eligibility 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)
Sites / Locations
- University of Leicester, Leicester Royal Infirmary, Ophthalmology Group
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
Visual acuity
Secondary Outcome Measures
nystagmus intensity, expanded nystagmus acuity function, reading ability, questionnaires, safety parameter
Full Information
NCT ID
NCT00661440
First Posted
April 15, 2008
Last Updated
November 25, 2009
Sponsor
Merz Pharmaceuticals GmbH
1. Study Identification
Unique Protocol Identification Number
NCT00661440
Brief Title
Efficacy and Safety Study of Neramexane to Treat Congenital and Acquired Nystagmus
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 Type
Interventional
2. Study Status
Record Verification Date
November 2009
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Merz Pharmaceuticals GmbH
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nystagmus, Congenital Idiopathic, Nystagmus, Acquired
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
48 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Other
Arm Title
2
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
Neramexane mesylate
Other Intervention Name(s)
- verum, placebo, - placebo, verum
Intervention Description
2 double-blind, cross-over treatment periods of 7 weeks separated by a wash-out phase, up to 75 mg Neramexane mesylate per day
Primary Outcome Measure Information:
Title
Visual acuity
Time Frame
Screening, Baseline, Week 3, 7, 11, 14, 18, and Follow-up
Secondary Outcome Measure Information:
Title
nystagmus intensity, expanded nystagmus acuity function, reading ability, questionnaires, safety parameter
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Irene Gottlob, Prof., MD
Organizational Affiliation
University of Leicester, Leicester, United Kingdom
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Leicester, Leicester Royal Infirmary, Ophthalmology Group
City
Leicester
ZIP/Postal Code
LE2 7LX
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety Study of Neramexane to Treat Congenital and Acquired Nystagmus
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