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

This study has suspended participant recruitment.
Sponsor:
Information provided by (Responsible Party):
Galapagos NV
ClinicalTrials.gov Identifier:
NCT01039103
First received: December 20, 2009
Last updated: October 24, 2011
Last verified: October 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Acute Exacerbation of Remitting Relapsing Multiple Sclerosis
Clinically Isolated Syndrome
 Drug: PEG-liposomal prednisolone sodium phosphate
Drug: Methylprednisolone
 Phase 2

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Galapagos NV:

Primary Outcome Measures:
  • Change in gadolinium-enhanced T1-weighted lesions according to the McDonald criteria (2005) from Day 8 to Week 8. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in gadolinium-enhanced T1-weighted lesions according to the McDonald criteria (2005) from Day 8 to Week 4. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Quality of life measured by changes in MSIS-29 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Clinical response measured by changes in MSFC [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Plasma levels of free prednisolone and prednisolone phosphate [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Occurrence of adverse events [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: December 2009
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Solu-Medrol

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01039103

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

No publications provided

Responsible Party: Galapagos NV
ClinicalTrials.gov Identifier: NCT01039103     History of Changes
Other Study ID Numbers: GLPG0303-CL-204, 2009-013884-21
Study First Received: December 20, 2009
Last Updated: October 24, 2011
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
Germany: Federal Institute for Drugs and Medical Devices
Poland: Ministry of Health
Poland: The Central Register of Clinical Trials

Keywords provided by Galapagos NV:
PEG-liposomal prednisolone sodium phosphate

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Methylprednisolone acetate
Prednisolone acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone
 Prednisolone hemisuccinate
Prednisolone phosphate
Sodium phosphate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents
Glucocorticoids

ClinicalTrials.gov processed this record on May 22, 2013