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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2015 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: June 29, 2015
Last verified: June 2015

October 31, 2012
June 29, 2015
December 2012
May 2016   (final data collection date for primary outcome measure)
change from baseline in visual evoked potential after 2 weeks and 3 months [ Time Frame: 5 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01720849 on ClinicalTrials.gov Archive Site
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Efficiency of 4-aminopyridin (Fampyra) on Gait, Vision, Cognition, Fatigue and Micturation in Patients With Multiple Sclerosis
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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
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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample
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.
  • Multiple Sclerosis
  • EDSS 4-7
Drug: Fampyra
The will be given as per normal patient treatment plan
Fampyra group
Intervention: Drug: Fampyra
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
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May 2016   (final data collection date for primary outcome measure)

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

Both
18 Years and older   (Adult, Senior)
No
Norway
 
NCT01720849
FampyraCSS
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Vestre Viken Hospital Trust
Vestre Viken Hospital Trust
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Vestre Viken Hospital Trust
June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP