A Phase I/II Study of Pixantrone in Patients with an Aggressive Relapsing Remitting (RR) or Secondary Progressive (SP) Multiple Sclerosis (PIXAMS)

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 20

Inclusion Criteria

1.patients with aggressive RR or SP MS who failed to respond to approved immunomodulatory drugs (interferons beta, glatiramer acetate) and who cannot or do not wish to receive mitoxantrone or tysabri.
2.patients within =18 and = 55 years of age
3.patients with a disease duration of maximum 15 years
4.clinically definite RR or SP MS, according to Lublin and Reingold definition and the McDonald criteria
5.Expanded Disability Status Scale Score (EDSS) = 2.5 and = 5.5
6.patients in the RR phase with a poor prognosis because of frequent (= 2/year) and severe relapses (transient EDSS =3) likely leading to permanent disability or patients in the SP phase with clinical signs or symptoms of rapid progression over the last year equivalent to an increase in EDSS of >/ 1 point
7.= 1 gadolinium enhancing lesion(s) at screening
8.left ventricular ejection fraction = 50%
9.standard laboratory parameters within the normal range, including hematology (lymphocytes > 1000/mm³, ANC (absolute neutrophil count) =2000/ml, thrombocytes =100.000/ml)
10.male or female patients:
NB: female patients of child-bearing potential should have a negative pregnancy test at the time of inclusion
male and female patients within reproductive ages should agree to practice effective contraception during the trial and for 6 months following the last administration of PIX.
11. have given written informed consent prior to treatment, with the understanding that consent may be withdrawn at any time without prejudice

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

1.previous treatment with immunosuppressants (Mitoxantrone or other anthracyclines, Cyclophosphamide, Methotrexate, Azathioprine, rituximab, alemtuzumab …) in the past year
2.in case of a recent relapse, the time from start of recovery/end of relapse to study entry should be at least one month
3.any corticosteroids or ACTH in the month preceding study entry
4.patients with cardiac risk factors: prior history of congestive heart failure, myocardial infarction, uncontrolled ischemic heart disease, hypertension or malignant hemopathy
5.patients treated with potential cardiotoxic drugs
6.patients who are at medical risks because of systemic disease which might interfere with patient safety (e.g.: impairment of renal or hepatic function, severe infection, alcohol abuse or drug addiction)
7.patients with impaired intellectual functions or psychiatric disorders preventing normal cooperation during the trial
8.participation in any investigational study within 4 weeks prior to treatment start; patient must have recovered from all side effects of other investigational therapy
9.history of, or clinical signs or symptoms suggestive of HIV, HBV, HCV
10.any circumstance at the time of study entry that would preclude completion of the study or the required follow-up.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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