Clinical trial NCT01039103: Nanocort in Acute Exacerbation of Relapsing-Remitting Multiple Sclerosis (MS)
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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Acute Exacerbation of Remitting Relapsing Multiple Sclerosis
Clinically Isolated Syndrome
Keywords: PEG-liposomal prednisolone sodium phosphate
Lead sponsor: Galapagos NV
Sponsor class: INDUSTRY
First posted: 2009-12-24
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.


Eligibility 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

Primary outcomes:
measure: Change in gadolinium-enhanced T1-weighted lesions according to the McDonald criteria (2005) from Day 8 to Week 8.
timeFrame: 8 weeks
Secondary outcomes:
measure: Change in gadolinium-enhanced T1-weighted lesions according to the McDonald criteria (2005) from Day 8 to Week 4.
timeFrame: 4 weeks
measure: Quality of life measured by changes in MSIS-29
timeFrame: 12 weeks
measure: Clinical response measured by changes in MSFC
timeFrame: 12 weeks
measure: Plasma levels of free prednisolone and prednisolone phosphate
timeFrame: 12 weeks
measure: Occurrence of adverse events
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Brugge
country: Belgium
facility: Departement Neurologie AZ St Jan AV
city: Melsbroek
country: Belgium
facility: Nationaal MS Centrum
city: Overpelt
country: Belgium
facility: Revalidatie & MS-centrum Overpelt
city: Bayreuth
country: Germany
facility: Krankenhaus Hohe Warte, Neurologische Klinik
city: Bochum
country: Germany
facility: St. Josef Hospital der Ruhr
city: Muenchen
country: Germany
facility: Klinikum Rechts der Isar der technischen Universitaet Muenchen, Neurologische Klinik und Poliklinik
city: Białystok
country: Poland
facility: Uniwersytecki Szpital Kliniczny w Białymstoku
city: Katowice
country: Poland
facility: Diagnomed-Clinical Research Sp. z o.o.
Study officials:
affiliation: Galapagos NV
name: Johan Beetens, PhD
role: STUDY_DIRECTOR
References: