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

Tracking Information
First Received Date ^ICMJE	May 19, 2008
Last Updated Date	February 12, 2009
Start Date ^ICMJE	February 2008
Estimated Primary Completion Date	September 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: May 19, 2008)	Neurological sacles [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00681980 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: May 19, 2008)	Quality of life [ Time Frame: 2009 ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Use Of Valproid Acid To Treat Tropical Spastic Paraparesis/HTLV-1-Associated Myelopathy (TSP/HAM)
Official Title ^ICMJE	Study Of Valproic Acid To Treat TSP/HAM Patients In Sao Paulo, Brazil
Brief Summary	Is the valproic acid efficacy to treat TSP/HAM
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Paraparesis Spastic Tropical
Intervention ^ICMJE	Drug: Valproic acid 15 mg/kg/day Drug: costicosteroids metypredsolone 1 g/day Drug: valproid acid plus corticosteroids valporid acid 15 mg/kg/day plus corticosteroids 1 g/patient
Study Arm (s)	Experimental: A, 2, III Patients with side effects to corticosteroids Intervention: Drug: Valproic acid Experimental: B patient with corticosteroids Intervention: Drug: costicosteroids Experimental: 3 Valproic acid and corticosteroids Intervention: Drug: valproid acid plus corticosteroids
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	60
Estimated Completion Date	December 2009
Estimated Primary Completion Date	September 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: HTLV-1; TSP/HAM fulfill criteria Exclusion Criteria: Age <18 years
Gender	Both
Ages	18 Years to 70 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Brazil

Administrative Information
NCT Number ^ICMJE	NCT00681980
Other Study ID Numbers ^ICMJE	278
Has Data Monitoring Committee	No
Responsible Party	Jorge Casseb, IMTSP
Study Sponsor ^ICMJE	University of Sao Paulo
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	University of Sao Paulo
Verification Date	February 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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