EUCTR2008-007549-29-DK
Active, not recruiting
Phase 1
Trichuris suis Ova Therapy for Relapsing Multiple Sclerosis - a safety study - TRIMS A
Danish Multiple Sclerosis Research Center0 sites10 target enrollmentMay 6, 2009
ConditionsRelapsing Multipel SclerosisMedDRA version: 12.0Level: LLTClassification code 10028245Term: Multiple sclerosisMedDRA version: 12.0Level: LLTClassification code 10063399Term: Relapsing-remitting multiple sclerosisMedDRA version: 12.0Level: LLTClassification code 10053395Term: Progressive multiple sclerosis
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Relapsing Multipel Sclerosis
- Sponsor
- Danish Multiple Sclerosis Research Center
- Enrollment
- 10
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •?age between 19 and 55 years
- •?relapsing course of multiple sclerosis (relapsing\-remitting or secondary progressive MS with relapses)
- •?duration of the disease of at least 1 year
- •?EDSS ? 5\.5 (expanded disability scale – see Appendix B and C)
- •?no disease modifying therapy or unchanged immunomodulatory therapy for the last 3 months
- •?at least 2 documented relapses during the last 24 months with the last relapse within the last 6 months or at least 1 documented relapse during the last 24 months with at least one Gadolinium positive lesion on a screening MRI.
- •?nine or more focal brain lesions on MRI according to the Barkhof criteria
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
Exclusion Criteria
- •?pregnancy or period of breastfeeding or missing adequate contraceptive protection for female premenopausal patients
- •?relapse in the last month prior enrolment
- •?treatment with steroids in the last 30 days
- •?previous treatment with mitoxantrone, cyclophosphamide or other intensive immunosupression, total irradiation or any kind of experimental therapy
- •?treatment with glatiramer acetate, azathioprine, IVIG or any other immunosuppressive or immunomodulatory drug apart from interferon\-beta in the 6 months prior to enrolment
- •?cardiac insufficiency (NYHA III/IV), cardiomyopathy, significant cardiac dysrhythmia requiring treatment, instable or advanced ischemic heart disease (CCS III or IV), malignant hypertension
- •?diabetes mellitus and other autoimmune diseases
- •?history of renal insufficiency
- •?stay in tropical areas during the last 3 months
- •?eosinophilia in the blood (\> 0,45 billion/l)
Outcomes
Primary Outcomes
Not specified
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