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)

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01039103

Enrollment

Registered

2009-12-24

Start date

2009-12-31

Completion date

2011-11-30

Last updated

2016-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Exacerbation of Remitting Relapsing Multiple Sclerosis, Clinically Isolated Syndrome

Keywords

PEG-liposomal prednisolone sodium phosphate

Brief summary

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.

Interventions

DRUGPEG-liposomal prednisolone sodium phosphate

PEG-liposomal prednisolone sodium phosphate 300 mg intravenous (IV), single dose 500 ml infusion over at least 2 hours on day 1

DRUGMethylprednisolone

Methylprednisolone 1 g, IV, infusion over 2 hours on days 1, 2 and 3

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Change in gadolinium-enhanced T1-weighted lesions according to the McDonald criteria (2005) from Day 8 to Week 8.	8 weeks

Secondary

Measure	Time frame
Change in gadolinium-enhanced T1-weighted lesions according to the McDonald criteria (2005) from Day 8 to Week 4.	4 weeks
Quality of life measured by changes in MSIS-29	12 weeks
Clinical response measured by changes in MSFC	12 weeks
Plasma levels of free prednisolone and prednisolone phosphate	12 weeks
Occurrence of adverse events	12 weeks

Countries

Belgium, Germany, Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026