Use Of Valproid Acid To Treat Tropical Spastic Paraparesi... | NCT00681980

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

NCT00681980

Sponsor

University of Sao Paulo

Status

Completed

Last Update Posted

Dec 3, 2015Estimated

Enrollment

60Actual

Phase

Phase 3

Conditions

Paraparesis Spastic Tropical

Interventions

Valproic acid
costicosteroids
valproid acid plus corticosteroids

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2008

Primary Completion Date

Sep 2009Actual

Completion Date

Dec 2015Actual

First Submitted Date

May 19, 2008

First Submission Date that Met QC Criteria

May 19, 2008

First Posted Date

May 21, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 1, 2015

Last Update Posted Date

Dec 3, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A, 2, III	Experimental	Patients with side effects to corticosteroids	Drug: Valproic acid
B	Experimental	patient with corticosteroids	Drug: costicosteroids
3	Experimental	Valproic acid and corticosteroids	Drug: valproid acid plus corticosteroids

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Valproic acid	Drug	15 mg/kg/day	A, 2, III
costicosteroids

Measure	Description	Time Frame
Neurological sacles		24 months

Measure	Description	Time Frame
Quality of life		2009

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

HTLV-1; TSP/HAM fulfill criteria

Exclusion Criteria:

Age <18 years

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Institute of Tropical Medicine at Sao Paulo University		São Paulo	São Paulo	0543903	Brazil

Label	URL
Related Info	View source

Condition Browse Module

MeSH Terms

ID	Term
D015493	Paraparesis, Tropical Spastic

Ancestor Terms

ID	Term
D009187	Myelitis
D002494	Central Nervous System Infections
D007239	Infections
D015490	HTLV-I Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014635	Valproic Acid
D000305	Adrenal Cortex Hormones

Ancestor Terms

ID	Term
D010421	Pentanoic Acids
D014631	Valerates
D000144	Acids, Acyclic
D002264	Carboxylic Acids

Browse Leaves

Not provided

Browse Branches

Not provided