Motor behaviour and cognition in multiple sclerosis patients
Conditions
Interventions
Trade Name: Fampyra
Pharmaceutical Form: Tablet
INN or Proposed INN: FAMPRIDINE
CAS Number: 504-24-5
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Sponsors
Medical University of Vienna
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients over 18 years with multiple sclerosis and an EDSS between 4 and 7, suffering from gait disturbance will be included. Only patients who have been identified as responders during a previous named patient programme and were refused to get reimbursement by the public health care system in Austria will be included. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 51 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion criteria will be a treatment with Fampridine less then 6 weeks before the start of the study, previously identified non-response to Fampridine and an age below 18 years.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Changes in basic and instrumental activities of daily life as assessed by the COPM and MS specific Fatigue Scale and Fatigue Severity Scale fMRI activity and connectivity changes;Timepoint(s) of evaluation of this end point: Baesline vs. 6 weeks | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of the study is to explore, if the use of Fampyra offers any meaningful improvement in the daily activity of patients as demanded from the public health care system in Austria. ;Secondary Objective: Moreover, the influence of Fampridine-SR on MS-related chronic fatigue and cognition will be studied. In a subset of study participants we seek to provide objective proof-of-concept evidence by use of functional magnetic resonance imaging (fMRI) of potential central effects of dalfampridine on remodelling of sensorimotor and cognitive cerebral networks. Further, by establishing fMRI correlates of behaviourally improved function, we wish to test whether fMRI could serve as a non-invasive functional biomarker in responders to this specific drug. The proposed approach would involve both assessments of changes in sensorimotor network activity (elicited by bipedal ankle-movements as a surrogate of the complex behaviour of gait) and in cognitive network activity (implicated in a response inhibition-disinhibition task). ;Primary end point(s): Changes in gait mobility as assessed by GTX3+ accelerometers after 6 weeks ;Timepoint(s) of evaluation of this end point: after 6 weeks | — |
Countries
Austria
Contacts
Public ContactClinical trial information desk
Wiener Pflege, PatientInnen und Patientenanwaltschaft
Outcome results
None listed