NCT01039103

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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Dec 2009

Geographic Reach
3 countries

8 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2009

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

December 20, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 24, 2009

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
Last Updated

October 6, 2016

Status Verified

October 1, 2016

Enrollment Period

1.9 years

First QC Date

December 20, 2009

Last Update Submit

October 5, 2016

Conditions

Acute Exacerbation of Remitting Relapsing Multiple SclerosisClinically Isolated Syndrome

Keywords

PEG-liposomal prednisolone sodium phosphate

Outcome Measures

Primary Outcomes (1)

  • Change in gadolinium-enhanced T1-weighted lesions according to the McDonald criteria (2005) from Day 8 to Week 8.

    8 weeks

Secondary Outcomes (5)

  • 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

  • Occurrence of adverse events

    12 weeks

Study Arms (2)

Nanocort

EXPERIMENTAL

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

Solu-Medrol

ACTIVE COMPARATOR

Methylprednisolone (Solu-Medrol) 1 g, IV, infusion over 2 hours on days 1, 2 and 3

Drug: Methylprednisolone

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

Also known as: Nanocort
Nanocort
MethylprednisoloneDRUG

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

Also known as: Solu-Medrol
Solu-Medrol

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Departement Neurologie AZ St Jan AV

Bruges, 8000, Belgium

Location

Nationaal MS Centrum

Melsbroek, 1820, Belgium

Location

Revalidatie & MS-centrum Overpelt

Overpelt, B-3900, Belgium

Location

Krankenhaus Hohe Warte, Neurologische Klinik

Bayreuth, 95445, Germany

Location

St. Josef Hospital der Ruhr

Bochum, 44791, Germany

Location

Klinikum Rechts der Isar der technischen Universitaet Muenchen, Neurologische Klinik und Poliklinik

München, 81675, Germany

Location

Uniwersytecki Szpital Kliniczny w Białymstoku

Bialystok, 15-276, Poland

Location

Diagnomed-Clinical Research Sp. z o.o.

Katowice, 40-594, Poland

Location

MeSH Terms

Interventions

MethylprednisoloneMethylprednisolone Hemisuccinate

Intervention Hierarchy (Ancestors)

PrednisolonePregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Johan Beetens, PhD

    Galapagos NV

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2009

First Posted

December 24, 2009

Study Start

December 1, 2009

Primary Completion

November 1, 2011

Study Completion

November 1, 2011

Last Updated

October 6, 2016

Record last verified: 2016-10

Locations

PL(2)BE(3)DE(3)