MedTrace Logo

Safety and Efficiency Study of Valproic Acid In HAM/TSP

NCT00519181 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2007-08-22

No results posted yet for this study

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

DRUG

Valproic Acid

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

Sponsors & Collaborators

  • University Hospital Pierre Zobda-Quitman

    lead OTHER

Principal Investigators

  • Stephane OLINDO, MD · University Hospital Pierre Zobda-Quitman, Fort de France

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-03-31
Completion
2007-06-30

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00519181 on ClinicalTrials.gov