Safety and Efficiency Study of Valproic Acid In HAM/TSP
Not Applicable
Terminated
- Conditions
- HTLV-I-Associated Myelopathy
- Registration Number
- NCT00519181
- Lead Sponsor
- University Hospital Pierre Zobda-Quitman
- Brief Summary
Reversible acetylation of the histone tails plays an important role in the control of specific gene expression. Mounting evidence has established that histone deacetylase inhibitors such as Valproic Acid (VPA)selectively induce cellular differentiation and apoptosis in variety of cancer cells. In a single-center, one year open-label trial, 19 HAM/TSP patients were treated with oral doses of VPA (20mg/Kg/day). Primary end-points were the therapeutic safety and the effect on HTLV-1 proviral load (a significant and sustained decrease was expected). Secondary end-point was the neurological status before and after one-year treatment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 19
Inclusion Criteria
- HAM/TSP patients diagnosed on WHO criteria
- Obtained informed consent.
Exclusion Criteria
- Patients with hepatic or nephrologic disease
- Valproic Acid allergy
- Pregnancy.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Clinical and laboratory safety of Valproic Acid in HAM/TSP. Effect on HTLV-1 proviral load in peripheral blood mononuclear cells. one year
- Secondary Outcome Measures
Name Time Method Neurological outcome. one year