Multiple Sclerosis
Conditions
Sponsors
Sønderjylland Hospital, department of neurology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with clinically definite multiple sclerosis diagnosed according to the McDonald criteria, aged 18-60 years, EDSS 4-7, pyramidal FS >= 2, able to transport self to University of Southern Denmark in Odense. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range 125 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: History of epileptic seizures, relapses of multiple sclerosis or change in disease modifying therapy within 60 days, cancer within five years, uncontrolled hypertension or clinically important cardiac, hepatic, renal or pulmonary disease, pregnancy and concomitant tratment with cimetidine, carvedilol, propranolol or metformine.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of the trial is to compose a multiple outcome measure trial to 1. evaluate the relative sensitivity of a comprehensive series of clinical tests for the identification of multiple sclerosis patients that respond to Fampyra 2. compare the effect size of Fampyra treatment when assessed by the Six Spot Step Test;Secondary Objective: ;Primary end point(s): The mean change in six spot step test from day 0 to 28.;Timepoint(s) of evaluation of this end point: 9 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Mean changes in Timed 25 Foot Walk, Hip Flexion Dynamometry, Knee Extension Dynamometry, Chair Rise Test, 9 Hole Peg Test and Symbol Digit Modalities Test.;Timepoint(s) of evaluation of this end point: 9 weeks | — |
Countries
Denmark
Outcome results
None listed