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

Galapagos

Status and phase

Terminated

Phase 2

Conditions

Acute Exacerbation of Remitting Relapsing Multiple Sclerosis

Clinically Isolated Syndrome

Treatments

Drug: PEG-liposomal prednisolone sodium phosphate

Drug: Methylprednisolone

Study type

Interventional

Funder types

Industry

Identifiers

NCT01039103

2009-013884-21 (EudraCT Number)

GLPG0303-CL-204

Details and patient eligibility

About

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.

Enrollment

15 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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