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Main
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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. |
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Register:
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EUCTR |
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Last refreshed on:
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19 March 2012 |
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Main ID: |
EUCTR2010-020369-26-DE |
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Date of registration:
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18/08/2010 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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High-Dose Corticosteroids for Immune Reconstitution Inflammatory Syndrome in Patients Who Develop Progressive Multifocal Leukoencephalopathy on Natalizumab
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Scientific title:
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High-Dose Corticosteroids for Immune Reconstitution Inflammatory Syndrome in Patients Who Develop Progressive Multifocal Leukoencephalopathy on Natalizumab |
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Date of first enrolment:
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29/11/2010 |
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Target sample size:
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20 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-020369-26 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: no
Open: yes
Single blind: no
Double blind: no
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: no
Other: no
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Phase:
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Countries of recruitment
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Germany
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
1. The subject or his/her legally authorized representative must understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information in accordance with national and local subject privacy regulations.
2. Age 18 years or older at the time of informed consent.
3. Subjects of childbearing potential must practice effective contraception during the study.
4. Must have been receiving natalizumab for multiple sclerosis prior to the diagnosis or suspicion of PML.
5. Subject must be willing to undergo or have completed PLEX (or equivalent) prior to initiating study treatment.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
1. History of severe allergic or anaphylactic reactions or known hypersensitivity to any drug including hypersensitivity to corticosteroids.
2. Female subjects who are pregnant or currently breastfeeding or are considering becoming pregnant while in the study.
3. Unwillingness or inability to comply with the requirements of this protocol including the presence of any condition (physical, mental, or social) that is likely to affect the subject's ability to comply with the study protocol.
4. Any other condition, clinical finding, or reason that, in the opinion of the Investigator and/or the Sponsor, is determined to be unsuitable for enrollment into this study.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Immune Reconstitution Inflammatory Syndrome
MedDRA version: 12.1
Level: PT
Classification code 10054014
Term: Immune reconstitution syndrome
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Intervention(s)
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Product Name: methylprednisolone
Pharmaceutical Form: Powder and solvent for solution for infusion
INN or Proposed INN: METHYLPREDNISOLONE
CAS Number: 83-43-2
Concentration unit: g gram(s)
Concentration type: equal
Concentration number: 1-
Product Name: prednisolone
Pharmaceutical Form: Tablet
INN or Proposed INN: PREDNISOLONE
CAS Number: 50-24-8
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 5-
Product Name: prednisolone
Pharmaceutical Form: Tablet
INN or Proposed INN: PREDNISOLONE
CAS Number: 50-24-8
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Product Name: prednisolone
Pharmaceutical Form: Tablet
INN or Proposed INN: PREDNISOLONE
CAS Number: 50-24-8
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
Product Name: prednisolone
Pharmaceutical Form: Tablet
INN or Proposed INN: PREDNISOLONE
CAS Number: 50-24-8
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Product Name: prednisolone
Pharmaceutical Form: Tablet
INN or Proposed INN: PREDNISOLONE
CAS Number: 50-24-8
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 1-
Product Name: prednisolone
Pharmaceutical Form: Tablet
INN or Proposed INN: PREDNISOLONE
CAS Number: 50-24-8
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 2-
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Primary Outcome(s)
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Primary end point(s): • Karnofsky Performance Status Scale
• Survival
• Adverse events and serious adverse events
• Global Clinical Impression of Improvement
• Symbol Digit Modalities Test
• Brain magnetic resonance imaging
• Magnetoencephalography
• Chemokines, cytokines, C-reactive protein
• JCV load and cell count in cerebrospinal fluid
• Serum natalizumab concentrations
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Secondary Objective:
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Main Objective: • To explore the effects of administering high-dose corticosteroids to subjects who develop Progressive Multifocal Leukoencephalopathywhile on natalizumab
• To characterize the evolution of Immune Reconstitution Inflammatory Syndrome
• To characterize the time course elimination of serum natalizumab concentrations in the study population following the last plasma exchange procedure
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Source(s) of Monetary Support
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Results
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Results available:
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Date Completed:
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