Trial | NCT00519181  Report issue

Title

Safety and Efficiency Study of Valproic Acid In HAM/TSP
Open Label Study of the Clinical and Laboratory Effects of Valproic Acid In HAM/TSP

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Terminated

  • Study Participants

    19
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.
Study Started
Mar 31
2006
Study Completion
Jun 30
2007
Last Update
Aug 22
2007
Estimate

Drug Valproic Acid

Valproic acid by oral route (20mg/Kg/day) during one year.

Criteria 

Inclusion Criteria:

HAM/TSP patients diagnosed on WHO criteria
Obtained informed consent.

Exclusion Criteria:

Patients with hepatic or nephrologic disease
Valproic Acid allergy
Pregnancy.
No Results Posted