Efficiency of 4-aminopyridin (Fampyra) on Gait, Vision, Cognition, Fatigue and Micturation in Patients With Multiple Sclerosis

This study is not yet open for participant recruitment.

Verified October 2012 by Vestre Viken Hospital Trust

Sponsor:

Information provided by (Responsible Party):

Vestre Viken Hospital Trust

ClinicalTrials.gov Identifier:

NCT01720849

First received: October 31, 2012

Last updated: November 1, 2012

Last verified: October 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	October 31, 2012
Last Updated Date	November 1, 2012
Start Date ^ICMJE	December 2012
Estimated Primary Completion Date	May 2013 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: November 1, 2012)	change from baseline in visual evoked potential after 2 weeks and 3 months [ Time Frame: 5 months ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01720849 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Efficiency of 4-aminopyridin (Fampyra) on Gait, Vision, Cognition, Fatigue and Micturation in Patients With Multiple Sclerosis
Official Title ^ICMJE	Not Provided
Brief Summary	The aim of the study is to assess improvement in visual evoked potential, cognition, fatigue, micturation and walking impairment under 3 months of Fampyra treatment
Detailed Description	Not Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Cohort Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	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.
Condition ^ICMJE	Multiple Sclerosis EDSS 4-7
Intervention ^ICMJE	Drug: Fampyra The will be given as per normal patient treatment plan
Study Group/Cohort (s)	Fampyra group Intervention: Drug: Fampyra
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	Not yet recruiting
Estimated Enrollment ^ICMJE	50
Completion Date	Not Provided
Estimated Primary Completion Date	May 2013 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	Norway

Administrative Information
NCT Number ^ICMJE	NCT01720849
Other Study ID Numbers ^ICMJE	FampyraCSS
Has Data Monitoring Committee	Not Provided
Responsible Party	Vestre Viken Hospital Trust
Study Sponsor ^ICMJE	Vestre Viken Hospital Trust
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Vestre Viken Hospital Trust
Verification Date	October 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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