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Safety and Efficiency Study of Valproic Acid In HAM/TSP (VALPROHAM)

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ClinicalTrials.gov Identifier: NCT00519181
Recruitment Status : Terminated
First Posted : August 22, 2007
Last Update Posted : August 22, 2007
Information provided by:
University Hospital Pierre Zobda-Quitman

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.

Condition or disease Intervention/treatment Phase
HTLV-I-Associated Myelopathy Drug: Valproic Acid Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open Label Study of the Clinical and Laboratory Effects of Valproic Acid In HAM/TSP
Study Start Date : March 2006
Actual Study Completion Date : June 2007

Intervention Details:
  • Drug: Valproic Acid
    Valproic acid by oral route (20mg/Kg/day) during one year.

Primary Outcome Measures :
  1. 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 Measures :
  1. Neurological outcome. [ Time Frame: one year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00519181

Sponsors and Collaborators
University Hospital Pierre Zobda-Quitman
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Principal Investigator: Stephane OLINDO, MD University Hospital Pierre Zobda-Quitman, Fort de France
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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ClinicalTrials.gov Identifier: NCT00519181    
Other Study ID Numbers: PHRC-SO-2006-17
First Posted: August 22, 2007    Key Record Dates
Last Update Posted: August 22, 2007
Last Verified: August 2007
Keywords provided by University Hospital Pierre Zobda-Quitman:
Additional relevant MeSH terms:
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Paraparesis, Tropical Spastic
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Central Nervous System Infections
HTLV-I Infections
Deltaretrovirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Valproic Acid
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
GABA Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs