NCT00519181

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2006

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 20, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 22, 2007

Completed
Last Updated

August 22, 2007

Status Verified

August 1, 2007

First QC Date

August 20, 2007

Last Update Submit

August 20, 2007

Conditions

HTLV-I-Associated Myelopathy

Keywords

HTLVHAM/TSPVALPROIC ACIDPROVIRAL LOAD

Outcome Measures

Primary Outcomes (1)

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

    one year

Secondary Outcomes (1)

  • Neurological outcome.

    one year

Interventions

Valproic AcidDRUG

Valproic acid by oral route (20mg/Kg/day) during one year.

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • HAM/TSP patients diagnosed on WHO criteria
  • Obtained informed consent.

You may not qualify if:

  • Patients with hepatic or nephrologic disease
  • Valproic Acid allergy
  • Pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 17717136DERIVED

MeSH Terms

Conditions

Paraparesis, Tropical Spastic

Interventions

Valproic Acid

Condition Hierarchy (Ancestors)

MyelitisCentral Nervous System InfectionsInfectionsHTLV-I InfectionsDeltaretrovirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesCentral Nervous System DiseasesNervous System DiseasesSpinal Cord DiseasesNeuroinflammatory Diseases

Intervention Hierarchy (Ancestors)

Pentanoic AcidsValeratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsFatty Acids, VolatileFatty AcidsLipids

Study Officials

  • Stephane OLINDO, MD

    University Hospital Pierre Zobda-Quitman, Fort de France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 20, 2007

First Posted

August 22, 2007

Study Start

March 1, 2006

Study Completion

June 1, 2007

Last Updated

August 22, 2007

Record last verified: 2007-08