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

This study has been terminated.
Information provided by:
University Hospital Pierre Zobda-Quitman Identifier:
First received: August 20, 2007
Last updated: NA
Last verified: August 2007
History: No changes posted
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 Intervention
HTLV-I-Associated Myelopathy Drug: Valproic Acid

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by University Hospital Pierre Zobda-Quitman:

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

Enrollment: 19
Study Start Date: March 2006
Study Completion Date: June 2007
Intervention Details:
    Drug: Valproic Acid
    Valproic acid by oral route (20mg/Kg/day) during one year.

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
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.
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Please refer to this study by its identifier: NCT00519181

Sponsors and Collaborators
University Hospital Pierre Zobda-Quitman
Principal Investigator: Stephane OLINDO, MD University Hospital Pierre Zobda-Quitman, Fort de France
  More Information

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00519181     History of Changes
Other Study ID Numbers: PHRC-SO-2006-17
Study First Received: August 20, 2007
Last Updated: August 20, 2007

Keywords provided by University Hospital Pierre Zobda-Quitman:

Additional relevant MeSH terms:
Paraparesis, Tropical Spastic
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
HTLV-I Infections
Deltaretrovirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Central Nervous System Infections
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 processed this record on September 21, 2017