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)

INTERVENTION: Product Name: PEG‐liposomal Prednisolone Sodium Phosphate Product Code: Nanocort Pharmaceutical Form: Liposomal dispersion for infusion INN or Proposed INN: Prednisolone Sodium Phosphate CAS Number: 125‐02‐0 Other descriptive name: PREDNISOLONE SODIUM PHOSPHATE Concentration unit: mg/ml milligram(s)/millilitre Concentration type: range Concentration number: 1.0‐3.2 Trade Name: Solu‐Medrol Pharmaceutical Form: Powder for infusion* INN or Proposed INN: METHYLPREDNISOLONE SODIUM SUCCINATE CAS Number: 03/03/2375 Other descriptive name: METHYLPREDNISOLONE SODIUM SUCCINATE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1000‐ CONDITION: Patients with acute exacerbation of Relapsing‐Remitting Multiple Sclerosis or Clinically Isolated Syndrome ; MedDRA version: 12.0 Level: LLT Classification code 10028245 Term: Multiple sclerosis PRIMARY OUTCOME: Main Objective: To assess the efficacy and safety of intravenous Polyethylene glycosylated (PEG)‐liposomal prednisolone sodium phosphate (Nanocort) vs intravenous methylprednisolone treatment in patients with acute exacerbation of relapsing‐remitting Multiple Sclerosis (RRMS) or in patients with CIS.; Primary end point(s): Change in gadolinium‐enhanced T1‐weighted lesions according to the McDonald criteria (2005) from Day 8 to Week 8. Secondary Objective: To explore the levels of free prednisolone and prednisolone phosphate; INCLUSION CRITERIA: Patients who are eligible for inclusion will be female or male patients, 18 to 65 years of age (inclusive), who have a 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 = 6.0, who have new neurological symptoms or exacerbation of prior neurological symptoms of over 24 hours duration but <7 days duration, verified by neurological examination and who have signed an 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) no F.1.3.1 Number of subjects for this age range