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

Phase 4

Completed

• Conditions: Multiple Sclerosis
• Interventions: Drug: Fampridine-SR

• Registration Number: NCT01656148
• Lead Sponsor: University of Southern Denmark

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-07-31
• Study First Submitted QC: 2012-07-31
• Study First Posted: 2012-08-02
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-22
• Last Update Posted: 2018-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fampridine-SR	Fampridine-SR	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.
Placebo	Fampridine-SR	In the intervention phase 50% will receive placebo BID

Primary Outcome Measures

Name	Time	Method
The mean change in SSST	SSST is measured before and at the end of four weeks of treatment	SSST is measured before treatment with Fampridine-SR. Then again measured at day 26, 27 or 28 of four weeks of treatment with Fampridine-SR.

Secondary Outcome Measures

Name	Time	Method
Mean change in T25FW	Four weeks	T25FW is measured before four weeks of treatment with Fampridine-SR and then on day 26, 27 or 28.
Mean change on Chair Rise Test	Four weeks	Time to rise from a chair five times is measured before four weeks of treatment with Fampridine-SR and on day 26, 27 or 28.
Mean change on 9-Hole Peg Test (9HPT)	Four weeks	9HPT is measured before four weeks of treatment with Fampridine-SR and on day 26, 27 or 28.
Mean change on Symbol Digit Modalitites Test (SDMT)	Four weeks	SDMT is measured before four weeks of treatment with Fampridine-SR and on day 26, 27 or 28.
Mean change in hip flexion, knee flexion and knee extension force	Four weeks	Force in the abovementioned areas is measured by dynamometry before four weeks of treatment with Fampridine-SR and on day 26, 27 or 28.

Trial Locations

Locations (4)

Esbjerg Hospital; 🇩🇰 Esbjerg, Denmark

Sønderborg Hospital; 🇩🇰 Sønderborg, Denmark

Odense University Hospital; 🇩🇰 Odense, Denmark

Vejle Hospital; 🇩🇰 Vejle, Denmark