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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
University Hospital Pierre Zobda-Quitman
About
Eligibility
Locations
Outcomes
Full info

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

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    August 20, 2007
    Last Updated
    August 20, 2007
    Sponsor
    University Hospital Pierre Zobda-Quitman
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    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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