We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov Menu

Hydroxyurea in Primary Progressive Multiple Sclerosis

This study has been terminated.
(No efficacy (interim.analysis))
ClinicalTrials.gov Identifier:
First Posted: April 14, 2010
Last Update Posted: February 11, 2014
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.
Information provided by:
S. Andrea Hospital
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 Intervention Phase
Multiple Sclerosis Drug: Hydroxyurea Other: placebo Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by S. Andrea Hospital:

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

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

Enrollment: 33
Study Start Date: July 2011
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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
  Contacts and Locations
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 ClinicalTrials.gov 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
  More Information

Responsible Party: Marco Salvetti, CENTERS
ClinicalTrials.gov Identifier: NCT01103583     History of Changes
Other Study ID Numbers: 2008-008521-29
First Submitted: April 13, 2010
First Posted: April 14, 2010
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