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

This study has been terminated.
Sponsor:
Information provided by:
University Hospital Pierre Zobda-Quitman
ClinicalTrials.gov Identifier:
NCT00519181
First received: August 20, 2007
Last updated: NA
Last verified: August 2007
History: No changes posted
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

U.S. FDA Resources

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00519181     History of Changes
Other Study ID Numbers: PHRC-SO-2006-17
Study First Received: August 20, 2007
Last Updated: August 20, 2007
Health Authority: France: Ministry of Health

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

Additional relevant MeSH terms:
Paraparesis, Tropical Spastic
Bone Marrow Diseases
Spinal Cord Diseases
Hematologic Diseases
Central Nervous System Diseases
Nervous System Diseases
Myelitis
Central Nervous System Viral Diseases
Virus Diseases
HTLV-I Infections
Deltaretrovirus Infections
Retroviridae Infections
RNA Virus Infections
Central Nervous System Infections
 Valproic Acid
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
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

ClinicalTrials.gov processed this record on May 16, 2013