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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-000888-15 |
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This is a phase IV, multicenter, randomized, double blind clinical trial. The investigators will study 48 patients with remitting relapsing multiple sclerosis (MS) experiencing moderate or severe attack receiving immunomodulatory therapy or not. Patients will be randomly assigned to one of the two groups.
This is a multicenter, randomized, double blind clinical trial to test whether oral methylprednisolone (MP) is not inferior to intravenous methylprednisolone for the treatment of multiple sclerosis (MS) relapse in terms of clinical and radiological efficacy.
Patients will be randomly assigned to one of the following two groups.
Group A: methylprednisolone 1.000 mg/day intravenous administered during three days + placebo of methylprednisolone orally administered
Group B: methylprednisolone 1.250 mg/day orally administered during three days + placebo of methylprednisolone intravenously administered.
Clinical visits will be conducted at 7, 28 and 90 days after treatment starting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | methylprednisolone 1.000 mg/day intravenous administration during three days + placebo of methylprednisolone orally administered |
|
| 2 | Experimental | methylprednisolone 1.250 mg/day orally administered during three days + placebo of methylprednisolone intravenous administered |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| methylprednisolone | Drug | methylprednisolone 1.000 mg/day intravenous administration during three days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in the punctuation of diana functional system score corresponding to in relapse of optic neuritis, trunk's syndrome and myelitis | day 28 | |
| Change in EDSS in patients who present a relapse from different type or unknown topography | day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the punctuation in each group | between days 7 and 0 | |
| Percentage of patients who improve, get worse and keep stable | days 7 and 28 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cristina Ramo, MD | Germans Trias i Pujol Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Germans Trias i Pujol Hospital | Badalona | Barcelona | 08916 | Spain | ||
| Hospital de Mataró |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26540732 | Derived | Ramo-Tello C, Tintore M, Rovira A, Ramio-Torrenta L, Brieva L, Saiz A, Cano A, Carmona O, Hervas JV, Grau-Lopez L. Baseline clinical status as a predictor of methylprednisolone response in multiple sclerosis relapses. Mult Scler. 2016 Jan;22(1):117-21. doi: 10.1177/1352458515590648. Epub 2015 Jun 25. | |
| 25145693 | Derived |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| ID | Term |
|---|---|
| D008775 | Methylprednisolone |
| ID | Term |
|---|---|
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
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| methylprednisolone | Drug | methylprednisolone 1.250 mg/day orally administered during three days |
|
|
| Placebo | Drug | Placebo of methylprednisolone administered intravenously (Arm 2) or orally (Arm 1) |
|
|
| Barcelona |
| Barcelona |
| 08034 |
| Spain |
| Hospital Vall d'Hebron | Barcelona | Barcelona | 08035 | Spain |
| Hospital Clinic de Barcelona | Barcelona | Barcelona | 08036 | Spain |
| Hospital de Figueres | Figueres | Girona | 17600 | Spain |
| Hospital Dr. Trueta | Girona | Girona | 17007 | Spain |
| Hospital Arnau de Vilanova | Lleida | Lleida | 25198 | Spain |
| Grau-Lopez L, Teniente-Serra A, Tintore M, Rovira A, Ramio-Torrenta L, Brieva L, Saiz A, Cano A, Carmona O, Hervas JV, Martinez-Caceres EM, Ramo-Tello C. Similar biological effect of high-dose oral versus intravenous methylprednisolone in multiple sclerosis relapses. Mult Scler. 2015 Apr;21(5):646-50. doi: 10.1177/1352458514546786. Epub 2014 Aug 21. |
| 24144876 | Derived | Ramo-Tello C, Grau-Lopez L, Tintore M, Rovira A, Ramio i Torrenta L, Brieva L, Cano A, Carmona O, Saiz A, Torres F, Giner P, Nos C, Massuet A, Montalban X, Martinez-Caceres E, Costa J. A randomized clinical trial of oral versus intravenous methylprednisolone for relapse of MS. Mult Scler. 2014 May;20(6):717-25. doi: 10.1177/1352458513508835. Epub 2013 Oct 21. |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013256 |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |