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

• Conditions: subjects affected by secondary-progressive Multiple Sclerosis; MedDRA version: 9.1Level: SOCClassification code 10029205

• Registration Number: EUCTR2009-010661-23-IT
• Lead Sponsor: AZIENDA OSPEDALIERA UNIVERSITARIA DELLA SECONDA UNIVERSITA` DEGLI STUDI DI NAPOLI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01-10
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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 <6; -subjects must be between 35-55 years of age; -subjects must have a LVEF >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

-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/μL.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified