Hydroxyurea in Primary Progressive Multiple Sclerosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01103583
Recruitment Status : Terminated (No efficacy (interim.analysis))
First Posted : April 14, 2010
Last Update Posted : February 11, 2014
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Drug: Hydroxyurea Other: placebo Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : July 2011
Actual Primary Completion Date : December 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Hydroxyurea

Arm Intervention/treatment
Experimental: Hydroxyurea Drug: Hydroxyurea
500 mg/die per os for two years

Placebo Comparator: Placebo Other: placebo
500 mg/die per os for two years

Primary Outcome Measures :
  1. the evaluation of safety and tolerability of hydroxyurea [ Time Frame: two years ]

Secondary Outcome Measures :
  1. the evaluation of efficacy of hydroxyurea in primary progressive multiple sclerosis [ Time Frame: two yeras ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01103583

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

Responsible Party: Marco Salvetti, CENTERS Identifier: NCT01103583     History of Changes
Other Study ID Numbers: 2008-008521-29
First Posted: April 14, 2010    Key Record Dates
Last Update Posted: February 11, 2014
Last Verified: December 2013

Additional relevant MeSH terms:
Multiple Sclerosis
Multiple Sclerosis, Chronic Progressive
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Antineoplastic Agents
Antisickling Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors