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

Phase 2TerminatedNCT01039103

Galapagos NV15 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

SINGLE

Enrollment

Conditions

Acute Exacerbation of Remitting Relapsing Multiple Sclerosis Clinically Isolated Syndrome

Interventions

PEG-liposomal prednisolone sodium phosphateDRUG

PEG-liposomal prednisolone sodium phosphate 300 mg intravenous (IV), single dose 500 ml infusion over at least 2 hours on day 1

MethylprednisoloneDRUG

Methylprednisolone 1 g, IV, infusion over 2 hours on days 1, 2 and 3

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (8)

Departement Neurologie AZ St Jan AV

Bruges, Belgium

Nationaal MS Centrum

Melsbroek, Belgium

Revalidatie & MS-centrum Overpelt

Overpelt, Belgium

Krankenhaus Hohe Warte, Neurologische Klinik

Bayreuth, Germany

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.

Time frame: 4 weeks

Quality of life measured by changes in MSIS-29

Time frame: 12 weeks

Clinical response measured by changes in MSFC

Time frame: 12 weeks

Plasma levels of free prednisolone and prednisolone phosphate

Time frame: 12 weeks

Occurrence of adverse events

Time frame: 12 weeks

Data from ClinicalTrials.gov

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