At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Fampyra Outcome Measures Study: a Study of Different Outcome Measures on the Effect of Fampyra
In Brief
A Phase 4 clinical trial evaluating Fampridine-SR for Multiple Sclerosis. Completed, enrolled 108 participants across 4 sites.
Detailed 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.
Study Details
Timeline
Interventions
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.