Hydroxyurea in Primary Progressive Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01103583
• Other study ID #: 2008-008521-29
• Status: Terminated
• Phase: Phase 2/Phase 3
• First received: April 13, 2010
• Last updated: February 10, 2014
• Start date: July 2011

Study information

• Verified date: December 2013
• Source: S. Andrea Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: National Bioethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 33
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• Hydroxyurea
500 mg/die per os for two years

Other:
• placebo
500 mg/die per os for two years

Locations

Country	Name	City	State
Italy	Centre for Experimental Neurological Therapies (CENTERS), S.Andrea Hospital	Rome
Italy	Centre for Experimental Neurological Therapies (CENTERS), Tor Vergata University Hospital	Rome

Sponsors (1)

Lead Sponsor	Collaborator
S. Andrea Hospital

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the evaluation of safety and tolerability of hydroxyurea		two years	Yes
Secondary	the evaluation of efficacy of hydroxyurea in primary progressive multiple sclerosis		two yeras	Yes