Efficacy and Safety of Tamibarotene(AM80H) for HTLV-1 Associated Myelopathy/ Tropical Spastic Paraparesis (HAM/TSP)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01343355 |
Recruitment Status
: Unknown
Verified July 2011 by St. Marianna University School of Medicine.
Recruitment status was: Active, not recruiting
First Posted
: April 28, 2011
Last Update Posted
: July 22, 2011
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
HTLV-I-Associated Myelopathy | Drug: Tamibarotene | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 15 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Open-Label, Exploratory Study of the Efficacy and Safety of Tamibarotene(AM80H) for HTLV-1 Associated Myelopathy/ Tropical Spastic Paraparesis (HAM/TSP) |
Study Start Date : | January 2011 |
Estimated Primary Completion Date : | March 2012 |
Estimated Study Completion Date : | March 2012 |

-
Drug: Tamibarotene
- 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 ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 30 Years to 75 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients who have been diagnosed as HAM according to the WHO criteria
- Patients who are positive for HTLV-I antibody in the spinal fluid
- Patients, if female, who are not pregnant or breastfeeding, either agreed to take contraceptive measures during and two years after the treatment, or sterile
- Patients, if male, who agreed to take contraceptive measures during and six months after the treatment
- Patients who have been informed and understood the contents of the study and consented to participate in the signed form.
Exclusion Criteria:
- Patients who has a rapid progress in the symptoms defined as an increase of two or more in Osame's Motor Disability Score for HAM patients in the past one year.
- Patients of hyperlipidemia (serum triglyceride higher than 400 mg/dL)
- Patients who were administered new or increased dose of corticosteroid in the past 8 weeks before the intervention
- Patients who received steroid pulse therapy in the past 8 weeks before the intervention
- Patients who were administered new or increased dose of immunosuppressant in the past 8 weeks before the intervention
- Patients with a history of serious drug allergy
- Patients with significant complication such as malignancy, severe heart failure, and other serious diseases.
- Patients who were in the past administered etretinate.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01343355
Japan | |
Iseikai Medical Corporation, Shoyo Kashiwadai Hospital | |
Kanagawa, Japan, 243-0402 |
Principal Investigator: | Yoshihisa Yamano, MD | St. Marianna University School of Medicine |
Additional Information:
Responsible Party: | Yoshihisa Yamano, MD, associate professor, Department of Molecular Medical Science, Institute of Medical Science |
ClinicalTrials.gov Identifier: | NCT01343355 History of Changes |
Other Study ID Numbers: |
AM80H-01 |
First Posted: | April 28, 2011 Key Record Dates |
Last Update Posted: | July 22, 2011 |
Last Verified: | July 2011 |
Keywords provided by St. Marianna University School of Medicine:
Tropical Spastic Paraparesis HAM TSP |
Additional relevant MeSH terms:
Muscle Spasticity Spinal Cord Diseases Bone Marrow Diseases Paraparesis Paraparesis, Spastic Paraparesis, Tropical Spastic Muscular Diseases Musculoskeletal Diseases Muscle Hypertonia Neuromuscular Manifestations Neurologic Manifestations Nervous System Diseases |
Signs and Symptoms Central Nervous System Diseases Hematologic Diseases Paresis HTLV-I Infections Deltaretrovirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Myelitis Central Nervous System Infections |