Safety and Efficiency Study of Valproic Acid In HAM/TSP

• Status: Terminated
• Trial end date: 2007-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital Pierre Zobda-Quitman
• Treatments: Valproic Acid

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.