Multiple Sclerosis
Conditions
Brief summary
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.
Interventions
DRUGHydroxyurea
500 mg/die per os for two years
OTHERplacebo
500 mg/die per os for two years
Sponsors
S. Andrea Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the evaluation of safety and tolerability of hydroxyurea | two years |
Secondary
| Measure | Time frame |
|---|---|
| the evaluation of efficacy of hydroxyurea in primary progressive multiple sclerosis | two yeras |
Countries
Italy
Outcome results
None listed