Ignite Creation Date:
2024-05-05 @ 6:37 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00519181
Status:
TERMINATED
Last Update Posted:
2007-08-22
First Post:
2007-08-20
Brief Title:
Safety and Efficiency Study of Valproic Acid In HAMTSP
Sponsor:
University Hospital Pierre Zobda-Quitman
Organization:
University Hospital Pierre Zobda-Quitman
Study Overview
Official Title:
Open Label Study of the Clinical and Laboratory Effects of Valproic Acid In HAMTSP
Status:
TERMINATED
Status Verified Date:
2007-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VALPROHAM
Brief 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 VPAselectively induce cellular differentiation and apoptosis in variety of cancer cells In a single-center one year open-label trial 19 HAMTSP patients were treated with oral doses of VPA 20mgKgday 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None