FAME - Fampyra Outcome Measures Study: a Study of Different Outcome Measures on the Effect of Fampyra

• Status: Completed
• Trial end date: 2014-05-01
• Target enrollment: 0
• Participant gender: All

Summary

Fampridine-SR is registered for the treatment of walking incapacity in MS patients. Two pivotal trials show that app. 40% of MS patients with walking incapacity can improve walking speed averagely 25% when recieving the drug. This has been shown using the Timed 25 Foot Walk Test (T25FW). No effect on cognition and upper limb function has been shown, but this has not been investigated in patients responding to the drug measured by the abovementioned test.

The question is if this will be the case and also if another walking test, termed the Six Spot Step Test (SSST), will be more sensitive to the effect of Fampridine-SR.

Primary outcome measure is the effect measured by SSST. The hypothesis is that SSST is not less sensitive to the effect of Fampridine-SR than T25FW.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Southern Denmark
• Collaborators: Biogen; Region of Southern Denmark
• Treatments: 4-Aminopyridine

Criteria

Inclusion Criteria:

• Patients with clinically definite multiple sclerosis diagnosed according to the McDonald criteria

• EDSS 4-7

• Pyramidal FS >= 2

Exclusion Criteria:

• History of epileptic seizures

• MS relapse or change in disease modifying treatment (DMT) within 60 days

• cancer within five years

• uncontrolled hypertension

• clinically important cardiac, hepatic, renal or pulmonary disease

• pregnancy

• breast feeding

• concomitant treatment with cimetidine, carvedilol, propranolol and metformin