Hydroxyurea in Primary Progressive Multiple Sclerosis
Primary Purpose
Multiple Sclerosis
Status
Terminated
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Hydroxyurea
placebo
Sponsored by

About this trial
This is an interventional treatment trial for Multiple Sclerosis
Eligibility 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
Sites / Locations
- Centre for Experimental Neurological Therapies (CENTERS), Tor Vergata University Hospital
- Centre for Experimental Neurological Therapies (CENTERS), S.Andrea Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Hydroxyurea
Placebo
Arm Description
Outcomes
Primary Outcome Measures
the evaluation of safety and tolerability of hydroxyurea
Secondary Outcome Measures
the evaluation of efficacy of hydroxyurea in primary progressive multiple sclerosis
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01103583
Brief Title
Hydroxyurea in Primary Progressive Multiple Sclerosis
Study Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Terminated
Why Stopped
No efficacy (interim.analysis)
Study Start Date
July 2011 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
S. Andrea Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hydroxyurea
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Hydroxyurea
Intervention Description
500 mg/die per os for two years
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
500 mg/die per os for two years
Primary Outcome Measure Information:
Title
the evaluation of safety and tolerability of hydroxyurea
Time Frame
two years
Secondary Outcome Measure Information:
Title
the evaluation of efficacy of hydroxyurea in primary progressive multiple sclerosis
Time Frame
two yeras
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Centre for Experimental Neurological Therapies (CENTERS), Tor Vergata University Hospital
City
Rome
ZIP/Postal Code
00133
Country
Italy
Facility Name
Centre for Experimental Neurological Therapies (CENTERS), S.Andrea Hospital
City
Rome
ZIP/Postal Code
00189
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
Hydroxyurea in Primary Progressive Multiple Sclerosis
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