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

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Acute Exacerbation of Remitting Relapsing Multiple Sclerosis, Clinically Isolated Syndrome

Intervention / Treatment
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* Drug: PEG-liposomal prednisolone sodium phosphate
* Drug: Methylprednisolone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PEG-liposomal prednisolone sodium phosphate