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)
Overview
- Phase
- Phase 2
- Intervention
- PEG-liposomal prednisolone sodium phosphate
- Conditions
- Acute Exacerbation of Remitting Relapsing Multiple Sclerosis
- Sponsor
- Galapagos NV
- Enrollment
- 15
- Locations
- 8
- Primary Endpoint
- Change in gadolinium-enhanced T1-weighted lesions according to the McDonald criteria (2005) from Day 8 to Week 8.
- Status
- Terminated
- Last Updated
- 9 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
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: PEG-liposomal prednisolone sodium phosphate
Solu-Medrol
Methylprednisolone (Solu-Medrol) 1 g, IV, infusion over 2 hours on days 1, 2 and 3
Intervention: Methylprednisolone
Outcomes
Primary Outcomes
Change in gadolinium-enhanced T1-weighted lesions according to the McDonald criteria (2005) from Day 8 to Week 8.
Time Frame: 8 weeks
Secondary Outcomes
- Change in gadolinium-enhanced T1-weighted lesions according to the McDonald criteria (2005) from Day 8 to Week 4.(4 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)
- Quality of life measured by changes in MSIS-29(12 weeks)