Safety and Efficiency Study of Valproic Acid In HAM/TSP
Overview
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.
Full Title of Study: “Open Label Study of the Clinical and Laboratory Effects of Valproic Acid In HAM/TSP”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: N/A
- Intervention Model: Single Group Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
Interventions
- Drug: Valproic Acid
- Valproic acid by oral route (20mg/Kg/day) during one year.
Clinical Trial Outcome Measures
Primary Measures
- Clinical and laboratory safety of Valproic Acid in HAM/TSP. Effect on HTLV-1 proviral load in peripheral blood mononuclear cells.
- Time Frame: one year
Secondary Measures
- Neurological outcome.
- Time Frame: one year
Participating in This Clinical Trial
Inclusion Criteria
- HAM/TSP patients diagnosed on WHO criteria – Obtained informed consent. Exclusion Criteria:
- Patients with hepatic or nephrologic disease – Valproic Acid allergy – Pregnancy.
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 80 Years
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- University Hospital Pierre Zobda-Quitman
- Overall Official(s)
- Stephane OLINDO, MD, Principal Investigator, University Hospital Pierre Zobda-Quitman, Fort de France
Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.