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Completed

NCT Number: NCT00681980

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

Is the valproic acid efficacy to treat TSP/HAM

Completed

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Key information

Conditions

Paraparesis Spastic Tropical Central Nervous System Diseases Central Nervous System Infections Deltaretrovirus Infections HTLV-I Infections Infections Myelitis Nervous System Diseases Neuroinflammatory Diseases Paraparesis, Tropical Spastic RNA Virus Infections Retroviridae Infections Spinal Cord Diseases Virus Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Institute of Tropical Medicine at Sao Paulo University

São Paulo, 0543903, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • HTLV-1; TSP/HAM fulfill criteria

Exclusion criteria

  • Age <18 years

Treatment and study plan

Valproic acid

Drug

15 mg/kg/day

costicosteroids

Drug

metypredsolone 1 g/day

valproid acid plus corticosteroids

Drug

valporid acid 15 mg/kg/day plus corticosteroids 1 g/patient

Primary outcomes

  1. Neurological sacles

    Time frame: 24 months

Secondary outcomes

  1. Quality of life

    Time frame: 2009

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study title

Study Of Valproic Acid To Treat TSP/HAM Patients In Sao Paulo, Brazil

Important dates

Study start
2008
Primary completion
2009
Study completion
2015
First posted
May 21, 2008
Registry last updated
Dec 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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