- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00799942
Open-lable Extension Study on Safety and Efficacy of Neramexane to Treat Congenital and Acquired Nystagmus
June 30, 2010 updated by: Merz Pharmaceuticals GmbH
Long-term Open-label Extension Study to Assess the Safety, Tolerability, and Efficacy of Neramexane Mesylate in Congenital Idiopathic Nystagmus and Acquired Nystagmus
The purpose of this study is to investigate the long-term safety, tolerability and efficacy of neramexane mesylate in the treatment of congenital idiopathic nystagmus (CIN).
In addition, a subgroup of multiple sclerosis (MS) patients suffering from acquired nystagmus will be included.
Study Overview
Status
Terminated
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
48
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Leicester, United Kingdom, LE2 7LX
- University of Leicester, Leicester Royal Infirmary, Ophthalmology Group
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 81 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- patients who has succesfully completed the lead-in study MRZ 92579-0707/1
Exclusion Criteria:
- Occurence of any major treatment-emergent adverse event or condition during the previous protocol (MRZ 92579-0707/1)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Long-term safety, Visual acuity
Time Frame: Baseline, week 4, month 3, 6, 9, 12, 18, 24, 30, 36 and follow-up
|
Baseline, week 4, month 3, 6, 9, 12, 18, 24, 30, 36 and follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2009
Study Registration Dates
First Submitted
November 27, 2008
First Submitted That Met QC Criteria
November 28, 2008
First Posted (ESTIMATE)
December 1, 2008
Study Record Updates
Last Update Posted (ESTIMATE)
July 1, 2010
Last Update Submitted That Met QC Criteria
June 30, 2010
Last Verified
June 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Nervous System Diseases
- Immune System Diseases
- Demyelinating Autoimmune Diseases, CNS
- Autoimmune Diseases of the Nervous System
- Demyelinating Diseases
- Autoimmune Diseases
- Eye Diseases
- Infant, Newborn, Diseases
- Cranial Nerve Diseases
- Ocular Motility Disorders
- Multiple Sclerosis
- Nystagmus, Pathologic
- Nystagmus, Congenital
Other Study ID Numbers
- MRZ 92579-0738/1
- 2007-007663-25
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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