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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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19 February 2015 |
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Main ID: |
NCT00228228 |
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Date of registration:
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26/09/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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TCV -01-002: T-Cell Vaccination in the Treatment of Probable Multiple Sclerosis
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Scientific title:
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T-Cell Vaccination in the Treatment of Probable Multiple Sclerosis |
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Date of first enrolment:
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May 2002 |
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Target sample size:
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80 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00228228 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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Israel
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Contacts
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Name:
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Mathilda Mandel, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Blood Bank, Sheba Medical Center, Tel-Hashomer, Israel |
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Name:
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Anat Achiron, MD PhD |
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Address:
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Telephone:
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972-3-5303932 |
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Email:
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Achiron@post.tau.ac.il |
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Affiliation:
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Name:
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Anat Achiron, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Multiple Sclerosis Center, Sheba Medical Center, Tel-Hashomer, Israel |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Ages 15-50
- Three months within the acute onset of neurological symptoms suggestive of multiple
sclerosis
- Diagnosis of clinically probable MS (CPMS) C3: 1 attack with at least 1 clinical
manifestation in addition to positive brain MRI as defined in the protocol,
signifying paraclinical evidence (Poser criteria 1983).
- Positive Brain MRI: at least 4 focal lesions involving the white matter of 3 lesions
if one is periventricular > 3mm diameter, each
- Negative pregnancy test and use of effective contraceptives for female patients who
are sexually active.
- Signed written informed consent.
Exclusion Criteria:
- Blood tests suggestive of other autoimmune diseases
- Known allergic reaction to MRI contrast media.
- A clear regression of the neurological symptoms after the first attack that excludes
a primary progressive course.
- Corticosteroid treatment in the previous 4 weeks.
- Previous treatment with immunosuppressive medications such as cyclophosphamide,
azathioprine, methotrexate, mitoxantrone, or cyclosporine.
- Previous treatment with interferon beta 1a or 1b copolymer-1 IVIg, plasmapheresis.
Age minimum:
15 Years
Age maximum:
50 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Multiple Sclerosis
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Intervention(s)
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Biological: T cell vaccination
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Primary Outcome(s)
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Time to progression to definite MS (second attack)
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The rate of progression to definite MS (second attack) during the study
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Secondary Outcome(s)
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The change in neurological disability as measured by the Expanded Disability Status Scale (EDSS)
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Change in the count of new gadolinium (GD) enhancing lesions from two baseline (B) MRIs to the final (F) MRIs
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Change in total volume of new GD enhancing lesions from two baseline MRIs (B) to the final MRIs (F)
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Secondary ID(s)
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SHEBA-01-2490-AA-CTIL
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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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