OngoingPhase 2Relapsing MS2006-002562-19

What it found

Still running

No result yet.

What was tested

Treatment tested

  • Antithymocyte
  • Cyclophosphamide anhydrous

What it measured

Main measures

  • The primary endpoint of the study is to evaluate the safety and the effect on Gd-enhanced MRI of ASCT using a new conditioning regimen CY 120 mg/Kg followed by ATG in a population of severe MS cases, with clinical and MRI signs of disease activity, unresponsive to conventional immunomodulating and immunosuppressive therapy.

    MRI lesionsSafety

Who could take part

Relapsing MS

Inclusion: - Age between 18 and 50 Clinically and laboratory definite RRMS or RP EDSS score between 3 and 6.5 Documented rapid progression over the previous year despite conventional therapies immunomodulating and immunosuppressive treatments, see below; progression is defined as a worsening of 1 or more EDSS points between 3 and 6 or 0.5 or more between 6 and 6.5 or at least three relapses in the previous year also without progression of the disease despite conventional therapies immunomodulating and immunosuppressive treatments, see below Presence of at least 1 enhancing area on brain MRI using a triple dose TD of Gd Previous treatment with immunomodulating drugs interferon beta or glatiramer acetate without efficacy Previous treatment with immunosuppressive drugs Mitoxantrone or CY at standard dosage without efficacy Acceptance of using a valid birth control Exclusion: Primary progressive or Secondary Progressive MS Relapse in the last 30 days Previous treatment with TBI or TLI Treatment with Interferons, Cop1 or steroids in the last month Treatment with CY, Mitoxantrone, Aza, or other immunosuppressant in the last 3 months Concomitant diseases of lungs, kidneys, liver, heart, endocrine or neurological systems, Infectious illnesses, Psychiatric disturbances Left ventricular ejection fraction 50 , unexplained ECG abnormalities History of recurrent urinary tract infections or respiratory infections Pregnancy, breast feedings, patient s non compliance to use birth control methods Contraindications for MRI

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

The objective is therefore the search of a new light immunoablative regimen, with a better safety profile than BEAM but with a similar efficacy.

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History

    1. Started

      Jan 2007

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