Safety and Efficiency Study of Valproic Acid In HAM/TSP — VALPROHAM  

HTLV-I-Associated Myelopathy Clinical Trial

Official title: Open Label Study of the Clinical and Laboratory Effects of Valproic Acid In HAM/TSP

Status Terminated

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HTLV-I-Associated Myelopathy

• NCT number: NCT00519181
• Study type: Interventional
• Source: University Hospital Pierre Zobda-Quitman
• Status: Terminated
• Phase: N/A
• Start date: March 2006
• Completion date: June 2007