Safety and Efficiency Study of Valproic Acid In HAM/TSP (VALPROHAM)

University Hospital Pierre Zobda-Quitman

Status: Terminated

Conditions: HTLV-I-Associated Myelopathy

Treatments: Drug: Valproic Acid

Study type: Interventional

Funder types: Other

Identifiers

NCT00519181

PHRC-SO-2006-17

Details and patient eligibility

About

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.

Enrollment: 19 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)