Back to resultsUse Of Valproid Acid To Treat Tropical Spastic Paraparesis/HTLV-1-Associated Myelopathy (TSP/HAM)
Primary Purpose
Paraparesis Spastic Tropical
Status
Completed
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Valproic acid
costicosteroids
valproid acid plus corticosteroids
Sponsored by
About this trial
This is an interventional treatment trial for Paraparesis Spastic Tropical focused on measuring TSP/HAM, HTLV-1, treatment
Eligibility Criteria
Inclusion Criteria:
- HTLV-1; TSP/HAM fulfill criteria
Exclusion Criteria:
- Age <18 years
Sites / Locations
- Institute of Tropical Medicine at Sao Paulo University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
A, 2, III
B
3
Arm Description
Patients with side effects to corticosteroids
patient with corticosteroids
Valproic acid and corticosteroids
Outcomes
Primary Outcome Measures
Neurological sacles
Secondary Outcome Measures
Quality of life
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00681980
Brief Title
Use Of Valproid Acid To Treat Tropical Spastic Paraparesis/HTLV-1-Associated Myelopathy (TSP/HAM)
Official Title
Study Of Valproic Acid To Treat TSP/HAM Patients In Sao Paulo, Brazil
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Is the valproic acid efficacy to treat TSP/HAM
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paraparesis Spastic Tropical
Keywords
TSP/HAM, HTLV-1, treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A, 2, III
Arm Type
Experimental
Arm Description
Patients with side effects to corticosteroids
Arm Title
B
Arm Type
Experimental
Arm Description
patient with corticosteroids
Arm Title
3
Arm Type
Experimental
Arm Description
Valproic acid and corticosteroids
Intervention Type
Drug
Intervention Name(s)
Valproic acid
Intervention Description
15 mg/kg/day
Intervention Type
Drug
Intervention Name(s)
costicosteroids
Intervention Description
metypredsolone 1 g/day
Intervention Type
Drug
Intervention Name(s)
valproid acid plus corticosteroids
Intervention Description
valporid acid 15 mg/kg/day plus corticosteroids 1 g/patient
Primary Outcome Measure Information:
Title
Neurological sacles
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Quality of life
Time Frame
2009
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
HTLV-1; TSP/HAM fulfill criteria
Exclusion Criteria:
Age <18 years
Facility Information:
Facility Name
Institute of Tropical Medicine at Sao Paulo University
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
0543903
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
Use Of Valproid Acid To Treat Tropical Spastic Paraparesis/HTLV-1-Associated Myelopathy (TSP/HAM)
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