Influence on brain perfusion and metabolism through pharmacologic agents

Conditions: MedDRA version: 8.1Level: PTClassification code 10028245Term: Multiple sclerosis
Multiple Sclerosis

Registration Number: EUCTR2006-004318-42-NL

Lead Sponsor: Department of Neurology UMCG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br>2) the difference in measures of brain metabolism before and after the use of trial medication in patients and healthy controls

Secondary Outcome Measures