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Safety and Efficiency Study of Valproic Acid In HAM/TSP

Information source: University Hospital Pierre Zobda-Quitman
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HTLV-I-Associated Myelopathy

Intervention: Valproic Acid (Drug)

Phase: N/A

Status: Terminated

Sponsored by: University Hospital Pierre Zobda-Quitman

Official(s) and/or principal investigator(s):
Stephane OLINDO, MD, Principal Investigator, Affiliation: University Hospital Pierre Zobda-Quitman, Fort de France


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 Details

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

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

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

Secondary outcome: Neurological outcome.


Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.


Inclusion Criteria:

- HAM/TSP patients diagnosed on WHO criteria

- Obtained informed consent.

Exclusion Criteria:

- Patients with hepatic or nephrologic disease

- Valproic Acid allergy

- Pregnancy.

Locations and Contacts

Additional Information

Starting date: March 2006
Last updated: August 20, 2007

Page last updated: August 20, 2015

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