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Efficacy and Safety of Tamibarotene(AM80H) for HTLV-1 Associated Myelopathy/ Tropical Spastic Paraparesis (HAM/TSP)
Sponsor: St. Marianna University School of Medicine
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.
Official title: Open-Label, Exploratory Study of the Efficacy and Safety of Tamibarotene(AM80H) for HTLV-1 Associated Myelopathy/ Tropical Spastic Paraparesis (HAM/TSP)
Key Details
Gender
All
Age Range
30 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
15
Start Date
2011-01
Completion Date
2011-10
Last Updated
2026-10-08
Healthy Volunteers
No
Conditions
Interventions
Tamibarotene
Oral administration of tamibarotene 2 mg daily over a period of 12 weeks, then 4mg daily for another 12 weeks.
Locations (1)
Iseikai Medical Corporation, Shoyo Kashiwadai Hospital
Kanagawa, Japan