Safety and Efficiency Study of Valproic Acid In HAM/TSP (VALPROHAM)
Primary Purpose
HTLV-I-Associated Myelopathy
Status
Terminated
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Valproic Acid
Sponsored by
About this trial
This is an interventional treatment trial for HTLV-I-Associated Myelopathy focused on measuring HTLV, HAM/TSP, VALPROIC ACID, PROVIRAL LOAD
Eligibility 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.
Sites / Locations
Outcomes
Primary Outcome Measures
Clinical and laboratory safety of Valproic Acid in HAM/TSP. Effect on HTLV-1 proviral load in peripheral blood mononuclear cells.
Secondary Outcome Measures
Neurological outcome.
Full Information
NCT ID
NCT00519181
First Posted
August 20, 2007
Last Updated
August 20, 2007
Sponsor
University Hospital Pierre Zobda-Quitman
1. Study Identification
Unique Protocol Identification Number
NCT00519181
Brief Title
Safety and Efficiency Study of Valproic Acid In HAM/TSP
Acronym
VALPROHAM
Official Title
Open Label Study of the Clinical and Laboratory Effects of Valproic Acid In HAM/TSP
Study Type
Interventional
2. Study Status
Record Verification Date
August 2007
Overall Recruitment Status
Terminated
Study Start Date
March 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University Hospital Pierre Zobda-Quitman
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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 (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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HTLV-I-Associated Myelopathy
Keywords
HTLV, HAM/TSP, VALPROIC ACID, PROVIRAL LOAD
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Valproic Acid
Intervention Description
Valproic acid by oral route (20mg/Kg/day) during one year.
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Neurological outcome.
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephane OLINDO, MD
Organizational Affiliation
University Hospital Pierre Zobda-Quitman, Fort de France
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
17717136
Citation
Lezin A, Gillet N, Olindo S, Signate A, Grandvaux N, Verlaeten O, Belrose G, de Carvalho Bittencourt M, Hiscott J, Asquith B, Burny A, Smadja D, Cesaire R, Willems L. Histone deacetylase mediated transcriptional activation reduces proviral loads in HTLV-1 associated myelopathy/tropical spastic paraparesis patients. Blood. 2007 Nov 15;110(10):3722-8. doi: 10.1182/blood-2007-04-085076. Epub 2007 Aug 23.
Results Reference
derived
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Safety and Efficiency Study of Valproic Acid In HAM/TSP
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