8 results
Primary: Safety and tolerability of fingolimod 0,5 mg.Secundairy: Efficacy and quality of life.
The purpose of this study in patients with primary progressive multiple sclerosis (PPMS) is to evaluatewhether FTY720 is effective in delaying MS disability progression in the absence of relapsescompared to placebo. Furthermore, safety and…
Primary: Safety and tolerability of fingolimod 0,5 mg in a broader population of MS patients.Explorerend: incidence of macular edema, bradyarrythmia, Patient-Reported Outcomes Indices for Multiple Sclerosis (PRIMuS) and Short Form Health Survey*12 (…
Primary: Safety and tolerability of fingolimod 0,5 mg.Secundairy: Long-term efficacy.Exploratory: Patient-Reported Outcomes Indices for Multiple Sclerosis (PRIMuS) and Short Form Health Survey*12 (SF-12), Treatment Satisfaction Questionnaire for…
The primary objective of this study is to determine the relation of delta PO2 (PaO2-tcPO2) and delta PCO2 (tcPCO2-cPCO2) levels to sepsis. The secondary aims are to determine the factors that influence delta PO2 and delta PCO2 and to determine the…
The primary objective of this study is to determine the accuracy of the delta PCO2 (PaCO2-tcPCO2) and delta PO2 (tcPO2 -cPO2) levels for the detection of sepsis. The secondary aims are to determine the factors that influence delta PCO2 and delta PO2…
The purpose of this study is to seek regulatory approval for use of fingolimod in a pediatric population with MS aged 10 to less than 18 years old. This study is conducted in line with the Pediatric Investigational Plan agreed with the EMA (under EU…
IVD1: The primary objective of this clinical performance study is to evaluate the effectiveness of the MyChoice® test in identifying HRRm or non-HRRm mCSPC patients as part of the enrolment criteria for EvoPAR-prostate01. This clinical performance…