Hydroxyurea in Primary Progressive Multiple Sclerosis

S. Andrea Hospital

Status and phase

Terminated

Phase 3

Phase 2

Conditions

Multiple Sclerosis

Treatments

Other: placebo

Drug: Hydroxyurea

Study type

Interventional

Funder types

Other

Identifiers

NCT01103583

2008-008521-29

Details and patient eligibility

About

The pathogenesis of MS remain elusive, however some studies have linked the disease with infection by Epstein-Barr virus; therefore the use of drugs with immunosuppressive or immunomodulating action alone may be less suitable for primary progressive MS.This study will evaluate treatment with hydroxyurea (HU) in primary progressive MS. Hydroxyurea act by inhibiting the synthesis of deoxynucleotides essential for viral transcription,HU has recently been used in combination with antiretroviral drugs in HIV and has been shown to limit immune activation and suppress viral load by both antiviral and cytostatic activities. Furthermore has been demonstrated experimentally that HU suppressed the expression of EBV. For these reasons HU could be useful in primary progressive MS with cytostatic and antiviral action , confirming the role of EBV in the pathogenesis of MS.

Enrollment

33 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

sign written informed consent
18 to 60 years of age inclusive
diagnosis of PP-MS according to McDonald criteria
EDSS score at screening of 2-7 inclusive

Exclusion criteria

hypersensitivity to hydroxyurea
patients who were treated with immunosuppressive drugs or steroid three month before
respiratory or urinary infections
history or presence of malignancy
pregnancy or lactation
low compliance to the therapy