Safety and Efficiency Study of Valproic Acid In HAM/TSP
Status:
Terminated
Trial end date:
2007-06-01
Target enrollment:
Participant gender:
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.