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

NCT ID: NCT00681980

Last Updated: 2015-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2015-12-31

Brief Summary

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Is the valproic acid efficacy to treat TSP/HAM

Detailed Description

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Conditions

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Paraparesis Spastic Tropical

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A, 2, III

Patients with side effects to corticosteroids

Group Type EXPERIMENTAL

Valproic acid

Intervention Type DRUG

15 mg/kg/day

B

patient with corticosteroids

Group Type EXPERIMENTAL

costicosteroids

Intervention Type DRUG

metypredsolone 1 g/day

3

Valproic acid and corticosteroids

Group Type EXPERIMENTAL

valproid acid plus corticosteroids

Intervention Type DRUG

valporid acid 15 mg/kg/day plus corticosteroids 1 g/patient

Interventions

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Valproic acid

15 mg/kg/day

Intervention Type DRUG

costicosteroids

metypredsolone 1 g/day

Intervention Type DRUG

valproid acid plus corticosteroids

valporid acid 15 mg/kg/day plus corticosteroids 1 g/patient

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* HTLV-1; TSP/HAM fulfill criteria

Exclusion Criteria

* Age \<18 years
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Jorge Casseb

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Institute of Tropical Medicine at Sao Paulo University

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

Related Links

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Other Identifiers

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278

Identifier Type: -

Identifier Source: org_study_id