Ignite Creation Date:
2025-12-24 @ 7:19 PM
Ignite Modification Date:
2025-12-25 @ 4:58 PM
Study NCT ID:
NCT01039103
Status:
TERMINATED
Last Update Posted:
2016-10-06
First Post:
2009-12-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Nanocort in Acute Exacerbation of Relapsing-Remitting Multiple Sclerosis (MS)
Sponsor:
Galapagos NV
Organization:
Study Overview
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)
Status:
TERMINATED
Status Verified Date:
2016-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2009-013884-21 | EUDRACT_NUMBER | None | View |