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Open Label Study of the Clinical and Laboratory Effects of Valproic Acid In HAM/TSP


N/A
18 Years
80 Years
Not Enrolling
Both
HTLV-I-Associated Myelopathy

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Trial Information

Open Label Study of the Clinical and Laboratory Effects of Valproic Acid In HAM/TSP


Inclusion Criteria:



- HAM/TSP patients diagnosed on WHO criteria

- Obtained informed consent.

Exclusion Criteria:

- Patients with hepatic or nephrologic disease

- Valproic Acid allergy

- Pregnancy.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Clinical and laboratory safety of Valproic Acid in HAM/TSP. Effect on HTLV-1 proviral load in peripheral blood mononuclear cells.

Outcome Time Frame:

one year

Principal Investigator

Stephane OLINDO, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital Pierre Zobda-Quitman, Fort de France

Authority:

France: Ministry of Health

Study ID:

PHRC-SO-2006-17

NCT ID:

NCT00519181

Start Date:

March 2006

Completion Date:

June 2007

Related Keywords:

  • HTLV-I-Associated Myelopathy
  • HTLV
  • HAM/TSP
  • VALPROIC ACID
  • PROVIRAL LOAD
  • Bone Marrow Diseases
  • Spinal Cord Diseases
  • Paraparesis, Tropical Spastic

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