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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 17 October 2016
Main ID:  NCT01039103
Date of registration: 20/12/2009
Prospective Registration: No
Primary sponsor: Galapagos NV
Public title: Nanocort in Acute Exacerbation of Relapsing-Remitting Multiple Sclerosis (MS)
Scientific title: A Randomized, International, Multi Centre Study to Assess the Efficacy and Safety of Intravenous PEG-liposomal Prednisolone Sodium Phosphate (NanocortĀ®) vs Intravenous Methylprednisolone (Solu-MedrolĀ®) Treatment in Patients With Acute Exacerbation of Relapsing-remitting Multiple Sclerosis or in Patients With Clinically Isolated Syndrome (CIS)
Date of first enrolment: December 2009
Target sample size: 15
Recruitment status: Terminated
URL:  https://clinicaltrials.gov/show/NCT01039103
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator)  
Phase:  Phase 2
Countries of recruitment
Belgium Germany Poland
Contacts
Name:     Johan Beetens, PhD
Address: 
Telephone:
Email:
Affiliation:  Galapagos NV
Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Acute Exacerbation of Remitting Relapsing Multiple Sclerosis
Clinically Isolated Syndrome
Intervention(s)
Drug: PEG-liposomal prednisolone sodium phosphate
Drug: Methylprednisolone
Primary Outcome(s)
Change in gadolinium-enhanced T1-weighted lesions according to the McDonald criteria (2005) from Day 8 to Week 8. [Time Frame: 8 weeks]
Secondary Outcome(s)
Change in gadolinium-enhanced T1-weighted lesions according to the McDonald criteria (2005) from Day 8 to Week 4. [Time Frame: 4 weeks]
Plasma levels of free prednisolone and prednisolone phosphate [Time Frame: 12 weeks]
Clinical response measured by changes in MSFC [Time Frame: 12 weeks]
Occurrence of adverse events [Time Frame: 12 weeks]
Quality of life measured by changes in MSIS-29 [Time Frame: 12 weeks]
Secondary ID(s)
GLPG0303-CL-204
2009-013884-21
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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