Hydroxyurea in Primary Progressive Multiple Sclerosis

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.

Study Overview

• Status: Terminated
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Drug: Hydroxyurea; Other: placebo

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Italy
  • Rome, Italy, 00133
    • Centre for Experimental Neurological Therapies (CENTERS), Tor Vergata University Hospital
  • Rome, Italy, 00189
    • Centre for Experimental Neurological Therapies (CENTERS), S.Andrea Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Other: placebo; 500 mg/die per os for two years
Experimental: Hydroxyurea	Drug: Hydroxyurea; 500 mg/die per os for two years

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
the evaluation of safety and tolerability of hydroxyurea	two years

Secondary Outcome Measures

Outcome Measure	Time Frame
the evaluation of efficacy of hydroxyurea in primary progressive multiple sclerosis	two yeras

Collaborators and Investigators

• Sponsor: S. Andrea Hospital

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: April 13, 2010
• First Submitted That Met QC Criteria: April 13, 2010
• First Posted (Estimate): April 14, 2010

Study Record Updates

• Last Update Posted (Estimate): February 11, 2014
• Last Update Submitted That Met QC Criteria: February 10, 2014
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis; Molecular Mechanisms of Pharmacological Action; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Antineoplastic Agents; Antisickling Agents; Hydroxyurea
• Other Study ID Numbers: 2008-008521-29