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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Oral administration of tamibarotene 2 mg daily over a period of 12 weeks, then 4mg daily for another 12 weeks.
Iseikai Medical Corporation, Shoyo Kashiwadai Hospital
Kanagawa, Japan
Change in Soluble IL-2 Receptor level in peripheral blood
Time frame: 0, 4, 8, 12, 16, 20, 24, 28 and 32 weeks
Change in HTLV-I viral load in peripheral blood
Time frame: 0, 4, 8, 12, 16, 20, 24, 28 and 32 weeks
Change in T cell population in peripheral blood
Time frame: 0,12, 24, 28 and 32 weeks
Change in cerebrospinal fluid examination
Time frame: baseline and after the treatment defined as from 24 to 32 weeks
Change in Osame's Motor Disability Score for HAM patients
Time frame: 0, 4, 8, 12, 16, 20, 24, 28 and 32 weeks
Change in The Expanded Disability Status Scale (EDSS)
Time frame: 0, 4, 8, 12, 16, 20, 24, 28 and 32 weeks
Change in timed 10m walk
Time frame: 0, 4, 8, 12, 16, 20, 24, 28 and 32 weeks
Change in Manual Muscle Testing and vibratory perception of the lower limbs
Time frame: 0, 4, 8, 12, 16, 20, 24, 28 and 32 weeks
Change in Modified Ashworth Scale
Time frame: 0, 4, 8, 12, 16, 20, 24, 28 and 32 weeks
Change in Urination function and defecation score
Time frame: 0, 4, 8, 12, 16, 20, 24, 28 and 32 weeks
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