Trials / Terminated
TerminatedNCT01039103
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)
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 15 (actual)
- Sponsor
- Galapagos NV · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
| DRUG | Methylprednisolone | Methylprednisolone 1 g, IV, infusion over 2 hours on days 1, 2 and 3 |
Timeline
- Start date
- 2009-12-01
- Primary completion
- 2011-11-01
- Completion
- 2011-11-01
- First posted
- 2009-12-24
- Last updated
- 2016-10-06
Locations
8 sites across 3 countries: Belgium, Germany, Poland
Source: ClinicalTrials.gov record NCT01039103. Inclusion in this directory is not an endorsement.