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Clinical Trial Summary

An open-label, non-randomised, uncontrolled, proof-of-concept study of patients with HTLV-I-associated myelopathy/Tropical Spastic Paraparesis (HAM/TSP). Participants will receive oral administration of tamibarotene in the amount of 2 mg daily over a period of 12 weeks, then 4mg daily for another 12 weeks. The patients will be followed up for further 8 weeks. Efficacy will be monitored by measuring clinical scores including motor and urination function, HTLV-1 proviral load, immunological parameters, and markers in the spinal fluid. Safety will be evaluated at the same time.


Clinical Trial Description

n/a


Study Design

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


Related Conditions & MeSH terms


NCT number NCT01343355
Study type Interventional
Source St. Marianna University School of Medicine
Contact
Status Active, not recruiting
Phase Phase 2/Phase 3
Start date January 2011
Completion date March 2012

See also
  Status Clinical Trial Phase
Terminated NCT00823641 - The HAM Infliximab Study Phase 2
Completed NCT00272480 - Zidovudine Plus Lamivudine in HTLV-I-associated Myelopathy: a Randomised Trial Phase 2/Phase 3
Terminated NCT00519181 - Safety and Efficiency Study of Valproic Acid In HAM/TSP N/A