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MITOXANTRONE/GLATIRAMER ACETATE COMBINED TREATMENT IN THE THERAPY OF SECONDARY-PROGRESSIVE MULTIPLE SCLEROSIS - aMICO STUDY

MITOXANTRONE/GLATIRAMER ACETATE COMBINED TREATMENT IN THE THERAPY OF SECONDARY-PROGRESSIVE MULTIPLE SCLEROSIS - aMICO STUDY

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2009-010661-23-IT
Enrollment
Unknown
Registered
2011-01-10
Start date
2009-07-30
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

subjects affected by secondary-progressive Multiple Sclerosis MedDRA version: 9.1 Level: SOC Classification code 10029205

Interventions

Pharmaceutical Form: Solution for injection INN or Proposed INN: Mitoxantrone Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 2- Pharmaceutical Form:

Sponsors

AZIENDA OSPEDALIERA UNIVERSITARIA DELLA SECONDA UNIVERSITA` DEGLI STUDI DI NAPOLI
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: -subjects must have a confirmed MS diagnosis as defined by the Revised McDonald criteria (Ann. Neurol. 58:840-846; 2005); - subjects must have a secondary-progressive form of MS (SPMS); -subjects must have a progression of at least 1 point on EDSS scale in the year before the inclusion; -subjects must be ambulatory with EDSS score 50%. 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: -use of immunosuppressive agents within one year prior to baseline; -corticosteroid treatment within 3 month prior to baseline; -subjects with clinically significant or unstable medical or surgical condition that preclude safe and complete study partecipation; -pregnancy; - cardiac abnormalities; - subjects with WBC < 4.0 x 103/&#956;L.

Design outcomes

Primary

MeasureTime frame
Main Objective: TO DETERMINE EFFICACY OF COMBINATION THERAPY WITH MITOXANTRONE AND GLATIRAMER ACETATE VERSUS MITOXANTRONE IN SECONDARY-PROGRESSIVE MUTLIPLE SCLEROSIS.;Secondary Objective: TO DETERMINE SAFETY OF COMBINATION THERAPY WITH MITOXANTRONE AND GLATIRAMER ACETATE IN SECONDARY-PROGRESSIVE MUTLIPLE SCLEROSIS.;Primary end point(s): -proportion of patients with confirmed progression of disability (progression of at least 1 EDSS point); -difference between final and baseline EDSS (&#916; EDSS); - brain atrophy as defined by the change from baseline to termination in normalized brain volume;—

Countries

Italy

Outcome results

None listed

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