Multiple Sclerosis
Conditions
Keywords
Multiple sclerosis, Walking disablility, Mobility, Six Spot Step Test, Outcome measures, Fampridine-SR, Fampyra
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.
Interventions
DRUGFampridine-SR
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.
Sponsors
Region of Southern Denmark
Biogen
University of Southern Denmark
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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. |
| 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. |
Countries
Denmark
Outcome results
None listed