Klassische Konditionierung immunologischer Reaktionen bei Patienten mit Multipler Sklerose während Mitoxantrontherapie - MIMIK
- Conditions
- secondary progressive multiple sclerosis
- Registration Number
- EUCTR2007-001962-34-DE
- Lead Sponsor
- niversity Medical Center Hamburg Eppendorf
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 5
secondary chronic progressive multiple sclerosis
mitoxantrone treatment for at least 6 months, but no treatmnet within the last 3 months, no steroid treatment within the last 30 days, age 21-55
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
malignant MS, acute relapse, drug-treated psychiatric disease, allergy against methylenblue, severe renal function disturbance, vaccination within the last 4 weeks, pregnancy, hypersensitivity against mitoxantrone, natriummetabisulfite, severe ongoing infections, cardiac diseases, renal and liver insufficiency
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To clarify the immunological effects of a placebo-infusion with methylenblue versus the drug mitoxantrone in an immune conditioning setting;Secondary Objective: ;Primary end point(s): rate of apotosis of B-cell as measured by FACS
- Secondary Outcome Measures
Name Time Method