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

Study Overview
=================
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.

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

Conditions
-----------------
Multiple Sclerosis

Intervention / Treatment
-----------------
* Drug: Fampridine-SR


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fampridine-SR<br>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. | Drug: Fampridine-SR<br>* 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.<br>* Other names: Fampyra (Ampyra in the US).;|
| Placebo Comparator: Placebo<br>In the intervention phase 50% will receive placebo BID | Drug: Fampridine-SR<br>* 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.<br>* Other names: Fampyra (Ampyra in the US).;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | SSST is measured before and at the end of four weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in T25FW | T25FW is measured before four weeks of treatment with Fampridine-SR and then on day 26, 27 or 28. | 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. | 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. | 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. | 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. | Four weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Multiple sclerosis, Walking disablility, Mobility, Six Spot Step Test, Outcome measures, Fampridine-SR, Fampyra