Multiple Sclerosis MedDRA version: 8.1 Level: PT Classification code 10028245 Term: Multiple sclerosis
Conditions
Interventions
Trade Name: Prepulsid
Pharmaceutical Form: Tablet
Trade Name: Spiropent
Pharmaceutical Form: Tablet
Sponsors
Department of Neurology UMCG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) a diagnosis of multiple sclerosis according to the McDonald criteria with a secondary progressive disease course and a disease duration of between ten and fifteen years. 2) age of eightteen years or older 3) written informed consent 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) use of systemic corticosteroids in the eight weeks before the trial 2) use of immunomodulatory treatments for MS 3) a history of cerebral pathology other than MS (cerebral infarct, cerebral haemorrhages, Parkinson's disease, Alzheimer's disease, cerebral vasculitis, brain absces) 4) diabetes mellitus, cardiac arrhythmia, prolonged qt time on ecg, pregnancy or breast-feeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: In this trial we would like to investigate the influence of two pharmacologic interventions on brain perfusion and brain metabolism in patients with MS and in healthy control persons. Brain metabolism will be investigated with magnetic resonance spectroscopy and brain perfusion will be examined with contrast enhanced magnetic resonance imaging.;Secondary Objective: ;Primary end point(s): 1) the difference in measures of cerebral perfusion before and after the use of trial medication in patients and controls 2) the difference in measures of brain metabolism before and after the use of trial medication in patients and healthy controls | — |
Countries
Netherlands
Outcome results
None listed