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

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)

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 Overview

• Status: Terminated
• Conditions: Clinically Isolated Syndrome; Acute Exacerbation of Remitting Relapsing Multiple Sclerosis
• Intervention / Treatment: Drug: PEG-liposomal prednisolone sodium phosphate; Drug: Methylprednisolone

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 2

Contacts and Locations

Study Locations

• Belgium
  • Brugge, Belgium, 8000
    • Departement Neurologie AZ St Jan AV
  • Melsbroek, Belgium, 1820
    • Nationaal MS Centrum
  • Overpelt, Belgium, B-3900
    • Revalidatie & MS-centrum Overpelt
• Germany
  • Bayreuth, Germany, 95445
    • Krankenhaus Hohe Warte, Neurologische Klinik
  • Bochum, Germany, 44791
    • St. Josef Hospital der Ruhr
  • Muenchen, Germany, 81675
    • Klinikum Rechts der Isar der technischen Universitaet Muenchen, Neurologische Klinik und Poliklinik
• Poland
  • Białystok, Poland, 15-276
    • Uniwersytecki Szpital Kliniczny w Białymstoku
  • Katowice, Poland, 40-594
    • Diagnomed-Clinical Research Sp. z o.o.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nanocort; PEG-liposomal prednisolone sodium phosphate (Nanocort) 300 mg intravenous (IV), single dose 500 ml infusion over at least 2 hours on day 1	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; Other Names: Nanocort
Active Comparator: Solu-Medrol; Methylprednisolone (Solu-Medrol) 1 g, IV, infusion over 2 hours on days 1, 2 and 3	Drug: Methylprednisolone; Methylprednisolone 1 g, IV, infusion over 2 hours on days 1, 2 and 3; Other Names: Solu-Medrol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in gadolinium-enhanced T1-weighted lesions according to the McDonald criteria (2005) from Day 8 to Week 8.	8 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Occurrence of adverse events	12 weeks
Change in gadolinium-enhanced T1-weighted lesions according to the McDonald criteria (2005) from Day 8 to Week 4.	4 weeks
Quality of life measured by changes in MSIS-29	12 weeks
Clinical response measured by changes in MSFC	12 weeks
Plasma levels of free prednisolone and prednisolone phosphate	12 weeks

Collaborators and Investigators

• Sponsor: Galapagos NV
• Investigators: Study Director: Johan Beetens, PhD, Galapagos NV

Study record dates

Study Major Dates

• Study Start: December 1, 2009
• Primary Completion (Actual): November 1, 2011
• Study Completion (Actual): November 1, 2011

Study Registration Dates

• First Submitted: December 20, 2009
• First Submitted That Met QC Criteria: December 22, 2009
• First Posted (Estimate): December 24, 2009

Study Record Updates

• Last Update Posted (Estimate): October 6, 2016
• Last Update Submitted That Met QC Criteria: October 5, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: PEG-liposomal prednisolone sodium phosphate
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Disease; Multiple Sclerosis; Sclerosis; Syndrome; Multiple Sclerosis, Relapsing-Remitting; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Neuroprotective Agents; Protective Agents; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
• Other Study ID Numbers: GLPG0303-CL-204; 2009-013884-21 (EudraCT Number)