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
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.
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
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.
Locations and Contacts
Additional Information
Starting date: March 2006
Last updated: August 20, 2007
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