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...
Date First Received: August 20, 2007
Last Updated: August 20, 2007
Verified by: University Hospital Pierre Zobda-Quitman, August 2007
Clinical Trial Phase: N/A | Start Date: March 2006
Overall Status: Terminated
Estimated Enrollment: 19
Brief Summary
Official Title: “Open Label Study of the Clinical and Laboratory Effects of Valproic Acid In HAM/TSP”
Condition Keyword(s):
Intervention(s):
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
Study Design: Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
Intervention(s) in this Clinical Trial
- Drug: Valproic Acid
- Valproic acid by oral route (20mg/Kg/day) during one year.
Outcome Measures for this Clinical Trial
Primary Measures
- 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
- Time Frame: one year
Secondary Measures
- Neurological outcome.
- Time Frame: one year
- Time Frame: one year
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- HAM/TSP patients diagnosed on WHO criteria
- Obtained informed consent.
Exclusion Criteria:
- Patients with hepatic or nephrologic disease
- Valproic Acid allergy
- Pregnancy.
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 80 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: University Hospital Pierre Zobda-Quitman
Overall Clinical Trial Officials and Contacts
Stephane OLINDO, MD Principal Investigator University Hospital Pierre Zobda-Quitman, Fort de France
Additional Information
Information obtained from ClinicalTrials.gov on October 10, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00519181
Study ID Number: PHRC-SO-2006-17
ClinicalTrials.gov Identifier: NCT00519181
Health Authority: France: Ministry of Health
Clinical Trials Authorship and Review
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