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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tamibarotene | Drug | Oral administration of tamibarotene 2 mg daily over a period of 12 weeks, then 4mg daily for another 12 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Soluble IL-2 Receptor level in peripheral blood | 0, 4, 8, 12, 16, 20, 24, 28 and 32 weeks | |
| Change in HTLV-I viral load in peripheral blood | 0, 4, 8, 12, 16, 20, 24, 28 and 32 weeks | |
| Change in T cell population in peripheral blood | 0,12, 24, 28 and 32 weeks | |
| Change in cerebrospinal fluid examination | baseline and after the treatment defined as from 24 to 32 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Osame's Motor Disability Score for HAM patients | 0, 4, 8, 12, 16, 20, 24, 28 and 32 weeks | |
| Change in The Expanded Disability Status Scale (EDSS) | 0, 4, 8, 12, 16, 20, 24, 28 and 32 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yoshihisa Yamano, MD | St. Marianna University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Iseikai Medical Corporation, Shoyo Kashiwadai Hospital | Kanagawa | 243-0402 | Japan |
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| ID | Term |
|---|---|
| D015493 | Paraparesis, Tropical Spastic |
| ID | Term |
|---|---|
| D009187 | Myelitis |
| D002494 | Central Nervous System Infections |
| D007239 | Infections |
| D015490 | HTLV-I Infections |
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| ID | Term |
|---|---|
| C061133 | tamibarotene |
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| Change in timed 10m walk | 0, 4, 8, 12, 16, 20, 24, 28 and 32 weeks |
| Change in Manual Muscle Testing and vibratory perception of the lower limbs | 0, 4, 8, 12, 16, 20, 24, 28 and 32 weeks |
| Change in Modified Ashworth Scale | 0, 4, 8, 12, 16, 20, 24, 28 and 32 weeks |
| Change in Urination function and defecation score | 0, 4, 8, 12, 16, 20, 24, 28 and 32 weeks |
| D006800 |
| Deltaretrovirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D013118 | Spinal Cord Diseases |
| D000090862 | Neuroinflammatory Diseases |