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

Phase 3

Completed

• Conditions: Paraparesis Spastic Tropical
• Interventions: Drug: Valproic acid; Drug: costicosteroids; Drug: valproid acid plus corticosteroids

• Registration Number: NCT00681980
• Lead Sponsor: University of Sao Paulo

Brief Summary

Is the valproic acid efficacy to treat TSP/HAM

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-05-19
• Study First Submitted QC: 2008-05-19
• Study First Posted: 2008-05-21
• Primary Completion: 2009-09
• Status Verified: 2015-12
• Study Completion: 2015-12
• Last Update Submitted: 2015-12-01
• Last Update Posted: 2015-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• HTLV-1; TSP/HAM fulfill criteria

Exclusion Criteria

• Age <18 years

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A, 2, III	Valproic acid	Patients with side effects to corticosteroids
B	costicosteroids	patient with corticosteroids
3	valproid acid plus corticosteroids	Valproic acid and corticosteroids

Primary Outcome Measures

Name	Time	Method
Neurological sacles	24 months

Secondary Outcome Measures

Name	Time	Method
Quality of life	2009

Trial Locations

Locations (1)

Institute of Tropical Medicine at Sao Paulo University; 🇧🇷 Sao Paulo, SP, Brazil