Hydroxyurea in Primary Progressive Multiple Sclerosis

Phase 2

Terminated

• Conditions: Multiple Sclerosis
• Interventions: Other: placebo; Drug: Hydroxyurea

• Registration Number: NCT01103583
• Lead Sponsor: S. Andrea Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-04-13
• Study First Submitted QC: 2010-04-13
• Study First Posted: 2010-04-14
• Study Start: 2011-07
• Status Verified: 2013-12
• Primary Completion: 2013-12
• Last Update Submitted: 2014-02-10
• Last Update Posted: 2014-02-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 33

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	placebo	-
Hydroxyurea	Hydroxyurea	-

Primary Outcome Measures

Name	Time	Method
the evaluation of safety and tolerability of hydroxyurea	two years

Secondary Outcome Measures

Name	Time	Method
the evaluation of efficacy of hydroxyurea in primary progressive multiple sclerosis	two yeras

Trial Locations

Locations (2)

Centre for Experimental Neurological Therapies (CENTERS), S.Andrea Hospital; 🇮🇹 Rome, Italy

Centre for Experimental Neurological Therapies (CENTERS), Tor Vergata University Hospital; 🇮🇹 Rome, Italy