Status:
UNKNOWN
TCV -01-002: T-Cell Vaccination in the Treatment of Probable Multiple Sclerosis
Lead Sponsor:
Sheba Medical Center
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
15-50 years
Phase:
PHASE3
Brief Summary
In the present study, we, the investigators at Sheba Medical Center, intend to evaluate T cell vaccination (TCV) in patients with probable multiple sclerosis (MS) within up to 3 months after the first...
Detailed Description
Inclusion criteria: * Age: 15 - 50 years. * Three months within the acute onset of neurological symptoms suggestive of the first attack of multiple sclerosis. * Diagnosis of CPMS C3 (Poser criteria)....
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2002
Trial Type :
INTERVENTIONAL
End Date :
December 1 2006
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00228228
Start Date
May 1 2002
End Date
December 1 2006
Last Update
August 29 2006
Active Locations (1)
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1
Sheba Medical Center
Ramat Gan, Israel, 52621