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

December 1, 2015 updated by: Jorge Casseb, University of Sao Paulo

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

Is the valproic acid efficacy to treat TSP/HAM

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • Sao Paulo, SP, Brazil, 0543903
        • Institute of Tropical Medicine at Sao Paulo University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • HTLV-1; TSP/HAM fulfill criteria

Exclusion Criteria:

  • Age <18 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A, 2, III
Patients with side effects to corticosteroids
Drug: Valproic acid
15 mg/kg/day
Experimental: B
patient with corticosteroids
Drug: costicosteroids
metypredsolone 1 g/day
Experimental: 3
Valproic acid and corticosteroids
Drug: valproid acid plus corticosteroids
valporid acid 15 mg/kg/day plus corticosteroids 1 g/patient

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Neurological sacles
Time Frame: 24 months
24 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Quality of life
Time Frame: 2009
2009

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

May 19, 2008

First Submitted That Met QC Criteria

May 19, 2008

First Posted (Estimate)

May 21, 2008

Study Record Updates

Last Update Posted (Estimate)

December 3, 2015

Last Update Submitted That Met QC Criteria

December 1, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 278

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Paraparesis Spastic Tropical

Clinical Trials on Valproic acid

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe