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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by University of Sao Paulo.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT00681980
First received: May 19, 2008
Last updated: February 12, 2009
Last verified: February 2009
History of Changes
  Purpose

Is the valproic acid efficacy to treat TSP/HAM


Condition Intervention Phase
Paraparesis Spastic Tropical
 Drug: Valproic acid
Drug: costicosteroids
Drug: valproid acid plus corticosteroids
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Study Of Valproic Acid To Treat TSP/HAM Patients In Sao Paulo, Brazil

Resource links provided by NLM:

MedlinePlus related topics: Steroids
U.S. FDA Resources

Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Neurological sacles [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Quality of life [ Time Frame: 2009 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: February 2008
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • HTLV-1; TSP/HAM fulfill criteria

Exclusion Criteria:

  • Age <18 years
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00681980

Locations
Brazil
Institute of Tropical Medicine at Sao Paulo University
Sao Paulo, SP, Brazil, 0543903
Sponsors and Collaborators
University of Sao Paulo
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Jorge Casseb, IMTSP
ClinicalTrials.gov Identifier: NCT00681980     History of Changes
Other Study ID Numbers: 278
Study First Received: May 19, 2008
Last Updated: February 12, 2009
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by University of Sao Paulo:
TSP/HAM, HTLV-1, treatment

Additional relevant MeSH terms:
Paraparesis, Tropical Spastic
Paraparesis, Spastic
Paraparesis
Muscle Spasticity
Myelitis
Central Nervous System Viral Diseases
Virus Diseases
HTLV-I Infections
Deltaretrovirus Infections
Retroviridae Infections
RNA Virus Infections
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Diseases
 Paresis
Neurologic Manifestations
Signs and Symptoms
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Valproic Acid
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
GABA Agents

ClinicalTrials.gov processed this record on June 18, 2013