Nanocort in Acute Exacerbation of Relapsing-Remitting Multiple Sclerosis (MS)
Information source: Galapagos NV
Information obtained from ClinicalTrials.gov on October 04, 2010
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: Recruiting
Sponsored by: Galapagos NV Official(s) and/or principal investigator(s):
Johan Beetens, PhD, Study Director, Affiliation: Galapagos NV
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.
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, Control: Active Control, 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
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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
Locations and Contacts
Departement Neurologie AZ St Jan AV, Brugge 8000, Belgium; Recruiting
Valerie Schotte, Phone: +32 50 452306, Email: Valerie.Schotte@azsintjan.be
Ludo Vanopdenbosch, MD, Principal Investigator
Nationaal MS Centrum, Melsbroek 1820, Belgium; Recruiting
Ann Van Remoortel, Phone: +32 2 597 87 24, Email: ann.vanremoortel@ms-centrum.be
Marie D'hooghe, MD, Principal Investigator
Revalidatie & MS-centrum Overpelt, Overpelt B-3900, Belgium; Recruiting
Bart Van Wijmeersch, PhD, MD, Email: bart.vanwijmeersch@med.kuleuven.be
Bart Van Wijmeersch, PhD, MD, Principal Investigator
Krankenhaus Hohe Warte, Neurologische Klinik, Bayreuth 95445, Germany; Recruiting
J. Hirsekorn, Phone: 0044 9214004614, Email: ms-studien@klinikum-bayreuth.de
Patrick Oschmann, Prof., Principal Investigator
St. Josef Hospital der Ruhr, Bochum 44791, Germany; Recruiting
Ralf Gold, Prof., Phone: 0049 234 509 24 11, Email: Ralf.Gold@ruhr-uni-bochum.de
Ralf Linker, MD, Email: Ralf.Linker@rub.de
Ralf Gold, Prof., Principal Investigator
Klinikum Rechts der Isar der technischen Universitaet Muenchen, Neurologische Klinik und Poliklinik, Muenchen 81675, Germany; Recruiting
Bernhard Hemmer, Prof., Phone: 0049 89 414 046 00, Email: hemmer@lrz.tu-muenchen.de
Achim Berthele, MD, Email: berthele@lrz.tu-muenchen.de
Bernhard Hemmer, Prof., Principal Investigator
Achim Berthele, MD, Sub-Investigator
Uniwersytecki Szpital Kliniczny w Białymstoku, Białystok 15-276, Poland; Recruiting
Wiesław Drozdowski, MD, PhD, Phone: +48 85 746 83 26, Email: drozdowski@cksr.ac.bialystok.pl
Wiesław Drozdowski, MD, Principal Investigator
Diagnomed-Clinical Research Sp. z o.o., Katowice 40-594, Poland; Not yet recruiting
Andrzej Wajgt, MD, Phone: +48 32 206 26 69, Email: wajgt@poczta.onet.pl
Andrzej Wajgt, Principal Investigator
Additional Information
Starting date: December 2009
Last updated: September 28, 2010
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