Relapsing-remitting (RR) multiple sclerosis (MS)
Conditions
Interventions
Trade Name: Gilenya
Pharmaceutical Form: Capsule
INN or Proposed INN: fingolimod
CAS Number: 162359-56-0
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.5-
Produ
Sponsors
VU University Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Subjects should be between 18 and 65 years of age - Subjects should meet the safety criteria to undergo MRI examination - Patients should be diagnosed with RRMS 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 70 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Presence or history of psychiatric or neurological disease (for patients: neurological disease other than MS) - Presence or history of drug abuse - For patients: relapse or steroid treatment less than four weeks prior to examination - Insufficient visual acuity and motor skills to perform the fMRI task
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate whether the disproportionally strong clinical effects of fingolimod in RRMS can be explained by enhanced functional brain adaptation and whether enhanced functional adaptation is sustained over time;Secondary Objective: 1. Does fingolimod affect functional connectivity as measured by resting-state fMRI? 2. Does fingolimod affect brain activation patterns and task performance during an information-processing task (task-related fMRI)? 3. Does fingolimod affect physical disability and cognitive decline? Is this effect measurable through functional adaptation? 4. Does fingolimod limit structural brain damage over time? 5. Does fingolimod enhance functional brain adaptation over time?;Primary end point(s): - Improved neuropsychological test performance - Changed functional MRI/connectivity - Improved cognitive well being;Timepoint(s) of evaluation of this end point: Six and eighteen months after baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): NA;Timepoint(s) of evaluation of this end point: NA | — |
Countries
Netherlands
Contacts
Public ContactSecretary
VU University Medical Center - Dept. of Anatomy and Neurosciences
Outcome results
None listed