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Clinical Trials/EUCTR2007-003086-40-BE
EUCTR2007-003086-40-BEActive, not recruitingPhase 1

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

Fondation Charcot Stichting0 sites20 target enrollmentStarted: November 21, 2007Last updated:
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Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Sponsor
Enrollment
20
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

Inclusion Criteria

  • •1. patients with aggressive relapsing-remitting 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 or patients with aggressive relapsing-progressive or secondary progressive MS who cannot or do not wish to receive mitoxantrone
  • •2.patients within = 18 and = 55 years of age
  • •3.clinically definite RR or SP MS, according to Lublin and Reingold definition and the McDonald criteria
  • •4.Expanded Disability Status Scale Score (EDSS) = 2.5 and = 5.5
  • •5.patients in the RR phase with a poor prognosis because of frequent (= 2/year) and severe relapses (transient EDSS =3) 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
  • •6.= 1 gadolinium enhancing lesion(s) within 3 months prior to screening or welldocumented new T2 lesion within 3 months prior to screening
  • •7.left ventricular ejection fraction = 50%
  • •8.standard laboratory parameters within the normal range, including hematology (lymphocytes > 1000/mm³, ANC (absolute neutrophil count) =2000/ml, thrombocytes =100.000/ml)
  • •9.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.
  • •10. have given written informed consent prior to treatment, with the understanding that consent may be withdrawn at any time without prejudice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, Cyclophosphamide, Methotrexate, Azathioprine, rituximab, alemtuzumab …) in the past year
  • •2.in case of a recent relapse, the time from start of relapse to study entry should be at least one month
  • •3.any high dose (500 mg or more) 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 or hypertension
  • •5.patients currently 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.

Investigators

Sponsor
Fondation Charcot Stichting

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