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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jorge Casseb, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT00681980
First received: May 19, 2008
Last updated: December 1, 2015
Last verified: December 2015

May 19, 2008
December 1, 2015
February 2008
September 2009   (final data collection date for primary outcome measure)
Neurological sacles [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00681980 on ClinicalTrials.gov Archive Site
Quality of life [ Time Frame: 2009 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Use Of Valproid Acid To Treat Tropical Spastic Paraparesis/HTLV-1-Associated Myelopathy (TSP/HAM)
Study Of Valproic Acid To Treat TSP/HAM Patients In Sao Paulo, Brazil
Is the valproic acid efficacy to treat TSP/HAM
Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Paraparesis Spastic Tropical
  • Drug: Valproic acid
    15 mg/kg/day
  • Drug: costicosteroids
    metypredsolone 1 g/day
  • Drug: valproid acid plus corticosteroids
    valporid acid 15 mg/kg/day plus corticosteroids 1 g/patient
  • Experimental: A, 2, III
    Patients with side effects to corticosteroids
    Intervention: Drug: Valproic acid
  • Experimental: B
    patient with corticosteroids
    Intervention: Drug: costicosteroids
  • Experimental: 3
    Valproic acid and corticosteroids
    Intervention: Drug: valproid acid plus corticosteroids
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
December 2015
September 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • HTLV-1; TSP/HAM fulfill criteria

Exclusion Criteria:

  • Age <18 years
Both
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT00681980
278
No
Not Provided
Not Provided
Jorge Casseb, University of Sao Paulo
University of Sao Paulo
Not Provided
Not Provided
University of Sao Paulo
December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP