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Exploratory trial to evaluate the risk-benefit ratio of the use of mitoxantrone in patients under treatment with high dose interferon-beta-1a for relapsing-remitting or relapsing secondary progresive multiple sclerosis with high activity. - Mitoxantrone in high activity multiple sclerosis

Exploratory trial to evaluate the risk-benefit ratio of the use of mitoxantrone in patients under treatment with high dose interferon-beta-1a for relapsing-remitting or relapsing secondary progresive multiple sclerosis with high activity. - Mitoxantrone in high activity multiple sclerosis

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2004-001286-17-PT
Enrollment
50
Registered
2006-03-23
Start date
2006-09-08
Completion date
Unknown
Last updated
2012-03-19

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

Conditions

Relapsing-remitting or relapsing secondary progressive multiple sclerosis with high activity MedDRA version: 7.0 Level: PT Classification code 10028245

Interventions

Product Name: Mitoxantrone Product Code: N/A Pharmaceutical Form: Solution for infusion

Sponsors

Fundación Española de Esclerosis Múltiple (FEDEM)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patient under treatment with high dose interferon-beta-1a at least for 12 months. EDSS equal or less than 5.5 Highly active multiple slcerosis defined bay at least 2 or more relapses in previous 12 months if relapsing-remitting or 1 relapse and progression of 1 point or more in EDSS. Normal left ventricular ejection fraction (LVEF). Aged 18-55 years. 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) F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Primary progressive multiple sclerosis or secondary progressive without relapses. Previous treatment with immunosuppressors or lymphoid irradiation. History of cardiac, hepatic, haemotological, renal, oncological disease or of other immunological disease different from multiple sclerosis. Known chronic infection, including HIV or HBV or HCV. Pragnancy or breast feeding.

Design outcomes

Primary

MeasureTime frame
Main Objective: To evaluate the risk-benefit ratio of the treatment with low dose mitoxantrone in patients with high activity multiple sclerosis under treatment with interferon-beta-1a at high dose.;Secondary Objective: To verify the safety of the treatment according to adverse event incidence and severity. To assess the potential benefit of the treatment by means of paired comparison (pre-/post-treatment) of both clinical and imaging (MRI) signs of disease activity.;Primary end point(s): Number of patients withdrawn beacuse of mielotoxicity, cardiotoxicity or severe adverse reactions. Annual relapse rate and annual EDSS progression.—

Countries

Portugal

Outcome results

None listed

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