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

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00519181
First Posted: August 22, 2007
Last Update Posted: August 22, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University Hospital Pierre Zobda-Quitman
  Purpose
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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
Investigators
Principal Investigator: Stephane OLINDO, MD University Hospital Pierre Zobda-Quitman, Fort de France
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00519181     History of Changes
Other Study ID Numbers: PHRC-SO-2006-17
First Submitted: August 20, 2007
First Posted: August 22, 2007
Last Update Posted: August 22, 2007
Last Verified: August 2007

Keywords provided by University Hospital Pierre Zobda-Quitman:
HTLV
HAM/TSP
VALPROIC ACID
PROVIRAL LOAD

Additional relevant MeSH terms:
Spinal Cord Diseases
Paraparesis, Tropical Spastic
Central Nervous System Diseases
Nervous System Diseases
HTLV-I Infections
Deltaretrovirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Myelitis
Central Nervous System Infections
Valproic Acid
Anticonvulsants
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


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