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

Clinically Isolated Syndrome Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01039103
• Other study ID #: GLPG0303-CL-204
• Secondary ID: 2009-013884-21
• Status: Terminated
• Phase: Phase 2
• First received: December 20, 2009
• Last updated: October 5, 2016
• Start date: December 2009
• Est. completion date: November 2011

Study information

• Verified date: October 2016
• Source: Galapagos NV
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health ProductsGermany: Federal Institute for Drugs and Medical DevicesPoland: Ministry of HealthPoland: The Central Register of Clinical Trials
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator)

Related Conditions & MeSH terms

• Acute Exacerbation of Remitting Relapsing Multiple Sclerosis
• Clinically Isolated Syndrome
• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Sclerosis
• Syndrome

Intervention

Drug:
• PEG-liposomal prednisolone sodium phosphate
PEG-liposomal prednisolone sodium phosphate 300 mg intravenous (IV), single dose 500 ml infusion over at least 2 hours on day 1
• Methylprednisolone
Methylprednisolone 1 g, IV, infusion over 2 hours on days 1, 2 and 3

Locations

Country	Name	City	State
Belgium	Departement Neurologie AZ St Jan AV	Brugge
Belgium	Nationaal MS Centrum	Melsbroek
Belgium	Revalidatie & MS-centrum Overpelt	Overpelt
Germany	Krankenhaus Hohe Warte, Neurologische Klinik	Bayreuth
Germany	St. Josef Hospital der Ruhr	Bochum
Germany	Klinikum Rechts der Isar der technischen Universitaet Muenchen, Neurologische Klinik und Poliklinik	Muenchen
Poland	Uniwersytecki Szpital Kliniczny w Bialymstoku	Bialystok
Poland	Diagnomed-Clinical Research Sp. z o.o.	Katowice

Sponsors (1)

Lead Sponsor	Collaborator
Galapagos NV

Countries where clinical trial is conducted

Belgium,  Germany,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in gadolinium-enhanced T1-weighted lesions according to the McDonald criteria (2005) from Day 8 to Week 8.		8 weeks	No
Secondary	Change in gadolinium-enhanced T1-weighted lesions according to the McDonald criteria (2005) from Day 8 to Week 4.		4 weeks	No
Secondary	Quality of life measured by changes in MSIS-29		12 weeks	No
Secondary	Clinical response measured by changes in MSFC		12 weeks	No
Secondary	Plasma levels of free prednisolone and prednisolone phosphate		12 weeks	No
Secondary	Occurrence of adverse events		12 weeks	No