Safety and Efficiency Study of Valproic Acid In HAM/TSP

N/ATerminatedNCT00519181

University Hospital Pierre Zobda-Quitman19 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

HTLV-I-Associated Myelopathy

Interventions

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * HAM/TSP patients diagnosed on WHO criteria * Obtained informed consent. Exclusion Criteria: * Patients with hepatic or nephrologic disease * Valproic Acid allergy * Pregnancy.

Outcomes

Primary Outcomes

Clinical and laboratory safety of Valproic Acid in HAM/TSP. Effect on HTLV-1 proviral load in peripheral blood mononuclear cells.

Time frame: one year

Secondary Outcomes

Neurological outcome.

Time frame: one year

Data from ClinicalTrials.gov

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