Klassische Konditionierung immunologischer Reaktionen bei Patienten mit Multipler Sklerose während Mitoxantrontherapie - MIMIK

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-001962-34-DE

Enrollment

Registered

2007-11-05

Start date

2007-12-12

Completion date

Unknown

Last updated

2016-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

secondary progressive multiple sclerosis

Interventions

Trade Name: Ralenova Pharmaceutical Form: Solution for injection INN or Proposed INN: mitoxantrone Current Sponsor code: Mitox Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equ

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
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	—

Countries

Germany

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026