EUCTR2005-001281-13-CZActive, not recruitingNot Applicable
Observational Study of Early Interferon beta 1-a Treatment in High Risk Subjects after CIS (SET Study) - SET Study
DSC Services, s.r.o.0 sites220 target enrollmentStarted: July 8, 2005Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 220
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •· Clinically isolated syndrome suspected from demyelinating event (no better explanation for present symptoms)
- •· First diagnostic MRI must be done before steroid treatment, with 3 mm slices without gap, without and with gadolinium, at least T1W and T2W images must be provided.
- •· MRI findings must reveal at least 2 hyperintense lesions on T2W or FLAIR images
- •· CSF examination confirms oligoclonal bands (examination must be done in an internationally approved lab and the CSF taken before the treatment of attack starts)
- •· Age 18 - 55 years, inclusive
- •· Effective contraception in female patients of childbearing potential
- •· Kurtzke EDSS = 3.5 at baseline, in an acute attack does not exceed 6.
- •· Willingness to accept the plan of the study and compliance with the study
- •· Time from the beginning of first symptoms of CIS to baseline visit does not exceeds
- •4 months (baseline MRI and baseline visit can be organized first 28 days after last steroid administration)
- •· CIS was treated by at least 3g of methylprednisolone without taper
- •· In case of severe attack 1 g of cyclophosphamide does not disqualify the patient from the study if first MRI and CSF examination was done before treatment administered
- •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) no
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •· The clinical diagnosis of Multiple Sclerosis is definite (the second attack occurs before the baseline visit)
- •· Active major organ disease, especially hepatic or endocrinologic
- •· Allergy to gadolinium
- •· History of alcohol or drug abuse within 2 years prior to study entry.
Investigators
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