Overview

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

Status:
Terminated
Trial end date:
2011-11-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Galapagos NV
Treatments:
Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
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