NCT00519181

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: University Hospital Pierre Zobda-Quitman · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HTLV-I-Associated Myelopathy

Interventions

Type	Name	Description
DRUG	Valproic Acid	Valproic acid by oral route (20mg/Kg/day) during one year.

Timeline

• Start date: 2006-03-01
• Completion: 2007-06-01
• First posted: 2007-08-22
• Last updated: 2007-08-22