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

This study has suspended participant recruitment.
Sponsor:
Information provided by (Responsible Party):
Galapagos NV
ClinicalTrials.gov Identifier:
NCT01039103
First received: December 20, 2009
Last updated: October 24, 2011
Last verified: October 2011

December 20, 2009
October 24, 2011
December 2009
April 2012   (final data collection date for primary outcome measure)
Change in gadolinium-enhanced T1-weighted lesions according to the McDonald criteria (2005) from Day 8 to Week 8. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01039103 on ClinicalTrials.gov Archive Site
  • Change in gadolinium-enhanced T1-weighted lesions according to the McDonald criteria (2005) from Day 8 to Week 4. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Quality of life measured by changes in MSIS-29 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Clinical response measured by changes in MSFC [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Plasma levels of free prednisolone and prednisolone phosphate [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Occurrence of adverse events [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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)

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
  • Acute Exacerbation of Remitting Relapsing Multiple Sclerosis
  • Clinically Isolated Syndrome
  • Drug: PEG-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
    Other Name: Nanocort
  • Drug: Methylprednisolone
    Methylprednisolone 1 g, IV, infusion over 2 hours on days 1, 2 and 3
    Other Name: Solu-Medrol
  • Experimental: Nanocort
    PEG-liposomal prednisolone sodium phosphate (Nanocort) 300 mg intravenous (IV), single dose 500 ml infusion over at least 2 hours on day 1
    Intervention: Drug: PEG-liposomal prednisolone sodium phosphate
  • Active Comparator: Solu-Medrol
    Methylprednisolone (Solu-Medrol) 1 g, IV, infusion over 2 hours on days 1, 2 and 3
    Intervention: Drug: Methylprednisolone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
90
September 2012
April 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Germany,   Poland
 
NCT01039103
GLPG0303-CL-204, 2009-013884-21
No
Galapagos NV
Galapagos NV
Not Provided
Study Director: Johan Beetens, PhD Galapagos NV
Galapagos NV
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP