Study Stopped
No efficacy (interim.analysis)
Hydroxyurea in Primary Progressive Multiple Sclerosis
1 other identifier
interventional
33
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 multiple-sclerosis
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 13, 2010
CompletedFirst Posted
Study publicly available on registry
April 14, 2010
CompletedStudy Start
First participant enrolled
July 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedFebruary 11, 2014
December 1, 2013
2.4 years
April 13, 2010
February 10, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
the evaluation of safety and tolerability of hydroxyurea
two years
Secondary Outcomes (1)
the evaluation of efficacy of hydroxyurea in primary progressive multiple sclerosis
two yeras
Study Arms (2)
Hydroxyurea
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- sign written informed consent
- to 60 years of age inclusive
- diagnosis of PP-MS according to McDonald criteria
- EDSS score at screening of 2-7 inclusive
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Centre for Experimental Neurological Therapies (CENTERS), Tor Vergata University Hospital
Rome, 00133, Italy
Centre for Experimental Neurological Therapies (CENTERS), S.Andrea Hospital
Rome, 00189, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 13, 2010
First Posted
April 14, 2010
Study Start
July 1, 2011
Primary Completion
December 1, 2013
Last Updated
February 11, 2014
Record last verified: 2013-12