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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-013884-21 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Solu-Medrol | Active Comparator | Methylprednisolone (Solu-Medrol) 1 g, IV, infusion over 2 hours on days 1, 2 and 3 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PEG-liposomal prednisolone sodium phosphate | Drug | PEG-liposomal prednisolone sodium phosphate 300 mg intravenous (IV), single dose 500 ml infusion over at least 2 hours on day 1 |
|
| 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 |
| 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 | |
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INCLUSION criteria
EXCLUSION criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Johan Beetens, PhD | Lakefront Biotherapeutics NV | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Departement Neurologie AZ St Jan AV | Bruges | 8000 | Belgium | |||
| Nationaal MS Centrum |
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|
| Methylprednisolone | Drug | Methylprednisolone 1 g, IV, infusion over 2 hours on days 1, 2 and 3 |
|
|
| 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 |
| Melsbroek |
| 1820 |
| Belgium |
| Revalidatie & MS-centrum Overpelt | Overpelt | B-3900 | Belgium |
| Krankenhaus Hohe Warte, Neurologische Klinik | Bayreuth | 95445 | Germany |
| St. Josef Hospital der Ruhr | Bochum | 44791 | Germany |
| Klinikum Rechts der Isar der technischen Universitaet Muenchen, Neurologische Klinik und Poliklinik | München | 81675 | Germany |
| Uniwersytecki Szpital Kliniczny w Białymstoku | Bialystok | 15-276 | Poland |
| Diagnomed-Clinical Research Sp. z o.o. | Katowice | 40-594 | Poland |
| ID | Term |
|---|---|
| D008775 | Methylprednisolone |
| D008776 | Methylprednisolone Hemisuccinate |
| ID | Term |
|---|---|
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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