NCT01656148

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 108 (actual)
• Sponsor: University of Southern Denmark · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	Fampridine-SR	Subjects will all receive Fampridine-SR in an open label enrichment phase lasting four weeks. Those 40% improvin the most measured by SSST will go onto the intervention. Here randomization in a 1:1 key between Fampridine-SR and placebo will be undertaken. Treatment will be of either Fampridine-SR 10 mg BID or placebo BID for four weeks. Arms will be double blind.

Timeline

• Start date: 2012-06-01
• Primary completion: 2014-05-01
• Completion: 2014-05-01
• First posted: 2012-08-02
• Last updated: 2018-08-23

Locations

4 sites across 1 country: Denmark