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
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, 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
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
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