Use Of Valproid Acid To Treat Tropical Spastic Paraparesis/HTLV-1-Associated Myelopathy (TSP/HAM)

This study has been completed.
Information provided by (Responsible Party):
Jorge Casseb, University of Sao Paulo Identifier:
First received: May 19, 2008
Last updated: December 1, 2015
Last verified: December 2015
Is the valproic acid efficacy to treat TSP/HAM

Condition Intervention Phase
Paraparesis Spastic Tropical
Drug: Valproic acid
Drug: costicosteroids
Drug: valproid acid plus corticosteroids
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Study Of Valproic Acid To Treat TSP/HAM Patients In Sao Paulo, Brazil

Resource links provided by NLM:

Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Neurological sacles [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Quality of life [ Time Frame: 2009 ] [ Designated as safety issue: Yes ]

Enrollment: 60
Study Start Date: February 2008
Study Completion Date: December 2015
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A, 2, III
Patients with side effects to corticosteroids
Drug: Valproic acid
15 mg/kg/day
Experimental: B
patient with corticosteroids
Drug: costicosteroids
metypredsolone 1 g/day
Experimental: 3
Valproic acid and corticosteroids
Drug: valproid acid plus corticosteroids
valporid acid 15 mg/kg/day plus corticosteroids 1 g/patient


Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • HTLV-1; TSP/HAM fulfill criteria

Exclusion Criteria:

  • Age <18 years
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Please refer to this study by its identifier: NCT00681980

Institute of Tropical Medicine at Sao Paulo University
Sao Paulo, SP, Brazil, 0543903
Sponsors and Collaborators
University of Sao Paulo
  More Information

Additional Information:
Responsible Party: Jorge Casseb, Professor, University of Sao Paulo Identifier: NCT00681980     History of Changes
Other Study ID Numbers: 278 
Study First Received: May 19, 2008
Last Updated: December 1, 2015
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by University of Sao Paulo:
TSP/HAM, HTLV-1, treatment

Additional relevant MeSH terms:
Paraparesis, Tropical Spastic
Central Nervous System Diseases
Central Nervous System Infections
Deltaretrovirus Infections
HTLV-I Infections
Nervous System Diseases
Neurologic Manifestations
RNA Virus Infections
Retroviridae Infections
Signs and Symptoms
Spinal Cord Diseases
Virus Diseases
Valproic Acid
Antimanic Agents
Central Nervous System Depressants
Enzyme Inhibitors
GABA Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Psychotropic Drugs
Tranquilizing Agents processed this record on May 26, 2016