Nanocort in Acute Exacerbation of Relapsing-Remitting Multiple Sclerosis (MS)

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)

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.

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