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

Multiple Sclerosis Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01720849
• Other study ID #: FampyraCSS
• Status: Recruiting
• Phase: N/A
• First received: October 31, 2012
• Last updated: June 29, 2015
• Start date: December 2012

Study information

• Verified date: June 2015
• Source: Vestre Viken Hospital Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Regional Ethics CommiteeNorway: Data Protection Authority
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• EDSS 4-7
• Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• Fampyra
The will be given as per normal patient treatment plan

Locations

Country	Name	City	State
Norway	Vestre Viken Helseforetak	Drammen

Sponsors (1)

Lead Sponsor	Collaborator
Vestre Viken Hospital Trust

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change from baseline in visual evoked potential after 2 weeks and 3 months		5 months	No