Safety and Efficiency Study of Valproic Acid In HAM/TSP

HTLV-I-Associated Myelopathy Clinical Trial

— VALPROHAM  

Official title:

Open Label Study of the Clinical and Laboratory Effects of Valproic Acid In HAM/TSP

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00519181
• Other study ID #: PHRC-SO-2006-17
• Status: Terminated
• Phase: N/A
• First received: August 20, 2007
• Last updated: August 20, 2007
• Start date: March 2006
• Est. completion date: June 2007

Study information

• Verified date: August 2007
• Source: University Hospital Pierre Zobda-Quitman
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 19
• Est. completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• HAM/TSP patients diagnosed on WHO criteria

• Obtained informed consent.

Exclusion Criteria:

• Patients with hepatic or nephrologic disease

• Valproic Acid allergy

• Pregnancy.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HTLV-I-Associated Myelopathy

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Pierre Zobda-Quitman

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical and laboratory safety of Valproic Acid in HAM/TSP. Effect on HTLV-1 proviral load in peripheral blood mononuclear cells.		one year
Secondary	Neurological outcome.		one year