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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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ClinicalTrials.gov |
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Last refreshed on:
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18 January 2016 |
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Main ID: |
NCT02644044 |
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Date of registration:
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23/03/2015 |
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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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Intrathecal Methotrexate for Progressive Multiple Sclerosis: An Open Label Single Arm Study
ITMTXPMS |
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Scientific title:
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Intrathecal Methotrexate for Progressive Multiple Sclerosis: An Open Label Single Arm Study |
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Date of first enrolment:
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January 2016 |
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Target sample size:
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30 |
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Recruitment status: |
Not yet recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02644044 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 0
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Contacts
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Name:
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Arnon Karni, MD |
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Address:
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Telephone:
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052-4266733 |
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Email:
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arnonk@tlvmc.gov.il |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Age 18-75 years
- Clinically definite diagnosis of MS according to McDonald criteria 2010.
- Progressive disease form defined by confirmed expanded disability status scale (EDSS)
progression without relapse by at least 0.5 point or greater in the six months prior
to enrollment.
Exclusion Criteria:
- Pregnancy
- Active infection
- Significant associated medical condition such as malignancy, heart disease or
concurrent other autoimmune condition.
- Known allergy to MTX.
- WBC<4000 cells/µL
- Lym<800 cells/µL
- Treated with fingolimod or natalizumab 3 months prior to enrollment
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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To Evaluate the Effect of Therapy With IT MTX on the Disease Course of Patients With Progressive MS
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Intervention(s)
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Drug: Intrathecal methotrexate
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Primary Outcome(s)
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Safety and tolerability (adverse events)
[Time Frame: each adverse event will be followed up until resolution]
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The change in disability ( Multiple Sclerosis Functional Composite (MSFC)
[Time Frame: 1 year]
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Secondary Outcome(s)
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Changes in brain MRI measurements
[Time Frame: 1 year]
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Laboratory measurements
[Time Frame: 1 year]
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Secondary ID(s)
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0166-15-TLV
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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