- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01720849
Efficiency of 4-aminopyridin (Fampyra) on Gait, Vision, Cognition, Fatigue and Micturation in Patients With Multiple Sclerosis
Study Overview
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Drammen, Norway, 3004
- Recruiting
- Vestre Viken Helseforetak
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Contact:
- Cecilia S Simonsen, MBChB
- Phone Number: +4798673256
- Email: ceciliasimonsen@yahoo.co.uk
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
All patients who according to the compound's Norwegian prescription guidelines are deemed eligible for the study, i.e. MS patients with impaired walking as determined by an EDSS 4-7. They do not need a past history of optic neuritis, cognitive failure, fatigue or difficulties micturating.
Exclusion Criteria:
MS patients with contraindications to the compound according to the prescription guidelines.
Patients who have been exposed to Fampyra in the past Patients with an MS attack within last 3 months
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Fampyra group
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The will be given as per normal patient treatment plan
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
change from baseline in visual evoked potential after 2 weeks and 3 months
Time Frame: 5 months
|
5 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FampyraCSS
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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