Hydroxyurea in Primary Progressive Multiple Sclerosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Hydroxyurea

Group Type EXPERIMENTAL

Hydroxyurea

Intervention Type DRUG

500 mg/die per os for two years

Placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

500 mg/die per os for two years

Interventions

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Hydroxyurea

500 mg/die per os for two years

Intervention Type DRUG

placebo

500 mg/die per os for two years

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No