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

University of Southern Denmark (SDU)

Status and phase: Completed; Phase 4

Conditions: Multiple Sclerosis

Treatments: Drug: Fampridine-SR

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01656148

2011-006151-10 (EudraCT Number)

FAME

Details and patient eligibility

About

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.

Enrollment: 108 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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108 participants in 2 patient groups, including a placebo group

Fampridine-SR

Experimental group

Description:

Initially all participants receive Fampridine-SR 10 mg BID in an open label enrichment phase lasting four weeks. Those 40% responding the most by SSST will go onto phase two. 50% of these will receive 10 mg Fampridine-SR BID for four weeks.

Treatment:

Drug: Fampridine-SR

Placebo

Placebo Comparator group

Description:

In the intervention phase 50% will receive placebo BID

Treatment:

Drug: Fampridine-SR