Nanocort in Acute Exacerbation of Relapsing-Remitting Multiple Scleros
A Randomized, International, Multi Centre Study to Assess the Efficacy and Safety of Intravenous PEG-liposomal Prednisolone Sodium Phosphate (Nanocort®) vs Intravenous Methylprednisolone (Solu-Medrol®) Treatment in Patients With Acute Exacerbation of Relapsing-remitting Multiple Sclerosis or in Patients With Clinically Isolated Syndrome (CIS)
What it found
The trial ended early for another reason (see below).
What was tested
Treatment tested
- PEG-liposomal prednisolone sodium phosphate
- Prednisolone phosphoric acid
Compared with
- Methylprednisolone
Glucocorticoid receptor agonist
- Methylprednisolone hemisuccinate
What it measured
Main measures
Change in gadolinium-enhanced T1-weighted lesions according to the McDonald criteria (2005) from Day 8 to Week 8.
8 weeks
MRI lesions
Other measures (5)
Change in gadolinium-enhanced T1-weighted lesions according to the McDonald criteria (2005) from Day 8 to Week 4.
4 weeks
MRI lesionsQuality of life measured by changes in MSIS-29
12 weeks
Quality of life (reported by participants)Clinical response measured by changes in MSFC
12 weeks
Disability progressionPlasma levels of free prednisolone and prednisolone phosphate
12 weeks
Occurrence of adverse events
12 weeks
Safety
Who could take part
Relapsing MS · 18 to 65
Show the full criteria
Inclusion criteria
* Diagnosis of RRMS (per McDonald criteria, 2005) with dissemination in time and space OR a diagnosis of CIS confirmed by MRI. Patients with CIS who only have optic neuritis will be excluded from this study * A maximum Expanded Disability Status Scale (EDSS) score of ≤ 6 * New neurological symptoms or exacerbation of prior neurological symptoms of over 24 hours duration but \<7 days duration, verified by neurological examination
Exclusion criteria
* Primary progressive MS. * Secondary progressive MS without superimposed relapses. * Received systemic corticosteroids within 4 weeks of screening for treatment of MS or other conditions. * any contraindication for treatment with (systemic) corticosteroids
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
Patients with an acute exacerbation of Relapsing-Remitting Multiple Sclerosis or with Clinically Isolated Syndrome receive either one single infusion of Nanocort or three daily infusions of SoluMedrol. Main objective is to assess the occurrence of new gadolinium-enhanced T1-weighted lesions at week 8 vs week 1 after treatment.
Papers
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History
Started
Dec 2009
Main results due
Nov 2011
Finished
Nov 2011