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

NCT01039103 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2016-10-06

No results posted yet for this study

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.

Conditions

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

Interventions

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

DRUG

Methylprednisolone

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

Sponsors & Collaborators

  • Galapagos NV

    lead INDUSTRY

Principal Investigators

  • Johan Beetens, PhD · Galapagos NV

Study Design

Allocation
RANDOMIZED
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2011-11-30
Completion
2011-11-30

Countries

  • Belgium
  • Germany
  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01039103 on ClinicalTrials.gov