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

University of Southern Denmark108 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

108

Conditions

Multiple Sclerosis

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (4)

Esbjerg Hospital

Esbjerg, Denmark

Odense University Hospital

Odense, Denmark

Sønderborg Hospital

Sønderborg, Denmark

Vejle Hospital

Vejle, Denmark

Outcomes

Primary Outcomes

The mean change in SSST

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.

Time frame: SSST is measured before and at the end of four weeks of treatment

Secondary Outcomes

Mean change in T25FW

T25FW is measured before four weeks of treatment with Fampridine-SR and then on day 26, 27 or 28.

Time frame: Four weeks

Mean change in hip flexion, knee flexion and knee extension force

Force in the abovementioned areas is measured by dynamometry before four weeks of treatment with Fampridine-SR and on day 26, 27 or 28.

Time frame: Four weeks

Mean change on Chair Rise Test

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.

Time frame: Four weeks

Mean change on 9-Hole Peg Test (9HPT)

9HPT is measured before four weeks of treatment with Fampridine-SR and on day 26, 27 or 28.

Time frame: Four weeks

Mean change on Symbol Digit Modalitites Test (SDMT)

SDMT is measured before four weeks of treatment with Fampridine-SR and on day 26, 27 or 28.

Time frame: Four weeks