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

Paraparesis Spastic Tropical Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00681980
• Other study ID #: 278
• Status: Completed
• Phase: Phase 3
• First received: May 19, 2008
• Last updated: December 1, 2015
• Start date: February 2008
• Est. completion date: December 2015

Study information

• Verified date: December 2015
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial Summary

Is the valproic acid efficacy to treat TSP/HAM

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2015
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• HTLV-1; TSP/HAM fulfill criteria

Exclusion Criteria:

• Age <18 years

Study Design

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

Related Conditions & MeSH terms

• Paraparesis
• Paraparesis Spastic Tropical

Intervention

Drug:
• Valproic acid
15 mg/kg/day
• costicosteroids
metypredsolone 1 g/day
• valproid acid plus corticosteroids
valporid acid 15 mg/kg/day plus corticosteroids 1 g/patient

Locations

Country	Name	City	State
Brazil	Institute of Tropical Medicine at Sao Paulo University	Sao Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neurological sacles		24 months	Yes
Secondary	Quality of life		2009	Yes

External Links

•   Link