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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
S. Andrea Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

First Posted
April 13, 2010
Last Updated
February 10, 2014
Sponsor
S. Andrea Hospital
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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

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Hydroxyurea in Primary Progressive Multiple Sclerosis

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