relapsing-remitting multiple sclerosis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: * Informed consent * Age: 18 * 55 years Additional criteria for pwRRMS: * A diagnosis of RRMS according to the McDonald criteria * A baseline Expanded Disability Status Scale
Exclusion criteria
Exclusion criteria: * History of alcohol or drug abuse or current alcohol or drug abuse * Neurologic condition unrelated to MS Psychiatric disorder (including affective disorders). * Other conditions/diseases influencing fatigue: o Chronic fatigue syndrome * Primary immunodeficiency. * Treatment with steroids within one month prior to inclusion * Participation in an investigational drug study within 3 months prior to inclusion * A MS relapse within one month prior to inclusion * Medication: o 4-aminopyridine or another form of fampridine o antidepressant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Association between fatigue (as measured with the FSS questionnaire) and measures of fatigability (changes in index finger abductor force and voluntary activation) in pwRRMS after 16 weeks of Tecfidera medication. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary study parameters are: 1. changes in the decline in voluntary, electrically evoked force and muscle activation during the fatiguing task (fatigability measures), and 2. changes in FSS scores after 16 weeks of Tecfidera medication (fatigue measures). | — |
Countries
Netherlands