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Hydroxyurea in Primary Progressive Multiple Sclerosis

This study is currently recruiting participants.
Verified July 2011 by S. Andrea Hospital
Sponsor:
Information provided by:
S. Andrea Hospital
ClinicalTrials.gov Identifier:
NCT01103583
First received: April 13, 2010
Last updated: July 19, 2011
Last verified: July 2011
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:

Drug Information available for: Hydroxyurea
U.S. FDA Resources

Further study details as provided by S. Andrea Hospital:

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

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

Estimated Enrollment: 60
Study Start Date: July 2011
Estimated Primary Completion Date: July 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

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01103583

Locations
Italy
Centre for Experimental Neurological Therapies (CENTERS), S.Andrea Hospital Recruiting
Rome, Italy, 00189
Contact: Silvia Romano, MD, PhD     +390633775994     silvia.romano@uniroma1.it    
Principal Investigator: Marco Salvetti, MD            
Centre for Experimental Neurological Therapies (CENTERS), Tor Vergata University Hospital Recruiting
Rome, Italy, 00133
Contact: Diego Centonze, MD     +390672596010     centonze@uniroma2.it    
Principal Investigator: Diego Centonze, MD            
Sponsors and Collaborators
S. Andrea Hospital
  More Information

No publications provided

Responsible Party: Marco Salvetti, CENTERS
ClinicalTrials.gov Identifier: NCT01103583     History of Changes
Other Study ID Numbers: 2008-008521-29
Study First Received: April 13, 2010
Last Updated: July 19, 2011
Health Authority: Italy: National Bioethics Committee

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

ClinicalTrials.gov processed this record on May 21, 2013