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

Information source: Galapagos NV
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acute Exacerbation of Remitting Relapsing Multiple Sclerosis; Clinically Isolated Syndrome

Intervention: PEG-liposomal prednisolone sodium phosphate (Drug); Methylprednisolone (Drug)

Phase: Phase 2

Status: Suspended

Sponsored by: Galapagos NV

Official(s) and/or principal investigator(s):
Johan Beetens, PhD, Study Director, Affiliation: Galapagos NV


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.

Clinical Details

Official title: 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)

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator)

Primary outcome: Change in gadolinium-enhanced T1-weighted lesions according to the McDonald criteria (2005) from Day 8 to Week 8.

Secondary outcome:

Change in gadolinium-enhanced T1-weighted lesions according to the McDonald criteria (2005) from Day 8 to Week 4.

Quality of life measured by changes in MSIS-29

Clinical response measured by changes in MSFC

Plasma levels of free prednisolone and prednisolone phosphate

Occurrence of adverse events


Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.


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

Locations and Contacts

Departement Neurologie AZ St Jan AV, Brugge 8000, Belgium

Nationaal MS Centrum, Melsbroek 1820, Belgium

Revalidatie & MS-centrum Overpelt, Overpelt B-3900, Belgium

Krankenhaus Hohe Warte, Neurologische Klinik, Bayreuth 95445, Germany

St. Josef Hospital der Ruhr, Bochum 44791, Germany

Klinikum Rechts der Isar der technischen Universitaet Muenchen, Neurologische Klinik und Poliklinik, Muenchen 81675, Germany

Uniwersytecki Szpital Kliniczny w Białymstoku, Białystok 15-276, Poland

Diagnomed-Clinical Research Sp. z o.o., Katowice 40-594, Poland

Additional Information

Starting date: December 2009
Last updated: October 24, 2011

Page last updated: August 23, 2015

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