search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Effects of fingolimod on advanced brain measures and clinical measures in multiple sclerosis


- candidate number18190
- NTR NumberNTR4657
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR23-jun-2014
- Secondary IDsCFTY720DNL02T Novartis
- Public TitleEffects of fingolimod on advanced brain measures and clinical measures in multiple sclerosis
- Scientific TitleEffects of fingolimod on functional brain adaptation and clinical measures in multiple sclerosis
- ACRONYM
- hypothesisWe expect that the disproportionally strong clinical effects of fingolimod in relapsing remitting multiple sclerosis can be explained by enhanced functional adaptation mechanisms of the brain and that enhanced functional adaptation will be sustained over time
- Healt Condition(s) or Problem(s) studiedMultiple sclerosis (MS), Functional MRI (fMRI), fMRI, Cognition
- 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
- 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
- mec approval receivedno
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-aug-2014
- planned closingdate1-aug-2018
- Target number of participants70
- Interventions(functional) magnetic resonance imaging and neuropsychological testing
- Primary outcome- Improved neuropsychological test performance
- Changed functional MRI/connectivity
- Improved cognitive well-being
- Secondary outcomeNA
- Timepointsbaseline, 6 months and 18 months
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES Quinten Geest, van
- CONTACT for SCIENTIFIC QUERIES Quinten Geest, van
- Sponsor/Initiator VU University Medical Center
- Funding
(Source(s) of Monetary or Material Support)
Novartis
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD23-jun-2014 - 28-jul-2014


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl