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HTLV-I-Associated Myelopathy clinical trials

View clinical trials related to HTLV-I-Associated Myelopathy.

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NCT ID: NCT00823641 Terminated - Clinical trials for HTLV-I-associated Myelopathy

The HAM Infliximab Study

HAM06
Start date: October 2008
Phase: Phase 2
Study type: Interventional

An open-label, non-randomised, uncontrolled, proof-of-concept study of eight patients with 'definite' HTLV-I-associated myelopathy/Tropical Spastic Paraparesis (HAM/TSP). Eligible patients will have either early disease (of less than 2 years duration) or progressive disease (with observed clinical deterioration during the preceding 3 months. Following 2 baseline assessments including Magnetic Resonance Imaging (MRI) of the spinal cord and a lumbar puncture for examination of the fluid around the brain (CSF) participants will be treated with a total of 7 infusions of the anti-TNF-alpha antibody infliximab over a period of 48 weeks. After the last on therapy assessment at 48 weeks participants will be followed up for a further 24 weeks. Study assessments will be clinical, virological, immunological and radiological. MRIs of the spinal cord will be obtained at weeks 12 and 72. CSF will be examined, on therapy, at week 12.

NCT ID: NCT00519181 Terminated - Clinical trials for HTLV-I-Associated Myelopathy

Safety and Efficiency Study of Valproic Acid In HAM/TSP

VALPROHAM
Start date: March 2006
Phase: N/A
Study type: Interventional

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.