Safety and Efficiency Study of Valproic Acid In HAM/TSP

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

TERMINATED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2007-06-30

Brief Summary

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Reversible acetylation of the histone tails plays an important role in the control of specific gene expression. Mounting evidence has established that histone deacetylase inhibitors such as Valproic Acid (VPA)selectively induce cellular differentiation and apoptosis in variety of cancer cells. In a single-center, one year open-label trial, 19 HAM/TSP patients were treated with oral doses of VPA (20mg/Kg/day). Primary end-points were the therapeutic safety and the effect on HTLV-1 proviral load (a significant and sustained decrease was expected). Secondary end-point was the neurological status before and after one-year treatment.

Detailed Description

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Conditions

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HTLV-I-Associated Myelopathy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Valproic Acid

Valproic acid by oral route (20mg/Kg/day) during one year.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* HAM/TSP patients diagnosed on WHO criteria
* Obtained informed consent.

Exclusion Criteria

* Patients with hepatic or nephrologic disease
* Valproic Acid allergy
* Pregnancy.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Stephane OLINDO, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Pierre Zobda-Quitman, Fort de France

References

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Lezin A, Gillet N, Olindo S, Signate A, Grandvaux N, Verlaeten O, Belrose G, de Carvalho Bittencourt M, Hiscott J, Asquith B, Burny A, Smadja D, Cesaire R, Willems L. Histone deacetylase mediated transcriptional activation reduces proviral loads in HTLV-1 associated myelopathy/tropical spastic paraparesis patients. Blood. 2007 Nov 15;110(10):3722-8. doi: 10.1182/blood-2007-04-085076. Epub 2007 Aug 23.

Reference Type DERIVED

PMID: 17717136 (View on PubMed)

Other Identifiers

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PHRC-SO-2006-17

Identifier Type: -

Identifier Source: org_study_id