Efficacy and Safety of Tamibarotene(AM80H) for HTLV-1 Associated Myelopathy/ Tropical Spastic Paraparesis (HAM/TSP)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by St. Marianna University School of Medicine.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
St. Marianna University School of Medicine
Information provided by:
St. Marianna University School of Medicine
ClinicalTrials.gov Identifier:
NCT01343355
First received: April 25, 2011
Last updated: July 21, 2011
Last verified: July 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
HTLV-I-Associated Myelopathy |
Drug: Tamibarotene |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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) |
Resource links provided by NLM:
MedlinePlus related topics:
Bone Marrow Diseases
Genetic and Rare Diseases Information Center resources:
HTLV-1 Associated Myelopathy/tropical Spastic Paraparesis
Human T-cell Leukemia Virus Type 1
Myelitis
Spastic Paraparesis
U.S. FDA Resources
Further study details as provided by St. Marianna University School of Medicine:
Primary Outcome Measures:
- Change in Soluble IL-2 Receptor level in peripheral blood [ Time Frame: 0, 4, 8, 12, 16, 20, 24, 28 and 32 weeks ] [ Designated as safety issue: No ]
- Change in HTLV-I viral load in peripheral blood [ Time Frame: 0, 4, 8, 12, 16, 20, 24, 28 and 32 weeks ] [ Designated as safety issue: No ]
- Change in T cell population in peripheral blood [ Time Frame: 0,12, 24, 28 and 32 weeks ] [ Designated as safety issue: No ]
- Change in cerebrospinal fluid examination [ Time Frame: baseline and after the treatment defined as from 24 to 32 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change in Osame's Motor Disability Score for HAM patients [ Time Frame: 0, 4, 8, 12, 16, 20, 24, 28 and 32 weeks ] [ Designated as safety issue: No ]
- Change in The Expanded Disability Status Scale (EDSS) [ Time Frame: 0, 4, 8, 12, 16, 20, 24, 28 and 32 weeks ] [ Designated as safety issue: No ]
- Change in timed 10m walk [ Time Frame: 0, 4, 8, 12, 16, 20, 24, 28 and 32 weeks ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- Change in Modified Ashworth Scale [ Time Frame: 0, 4, 8, 12, 16, 20, 24, 28 and 32 weeks ] [ Designated as safety issue: No ]
- Change in Urination function and defecation score [ Time Frame: 0, 4, 8, 12, 16, 20, 24, 28 and 32 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 15 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | March 2012 |
| Estimated Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Drug: Tamibarotene
Oral administration of tamibarotene 2 mg daily over a period of 12 weeks, then 4mg daily for another 12 weeks.
Eligibility| Ages Eligible for Study: | 30 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01343355
Please refer to this study by its ClinicalTrials.gov identifier: NCT01343355
Locations
| Japan | |
| Iseikai Medical Corporation, Shoyo Kashiwadai Hospital | |
| Kanagawa, Japan, 243-0402 | |
Sponsors and Collaborators
St. Marianna University School of Medicine
Investigators
| Principal Investigator: | Yoshihisa Yamano, MD | St. Marianna University School of Medicine |
More Information
Additional Information:
No publications provided
| 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 |
| Study First Received: | April 25, 2011 |
| Last Updated: | July 21, 2011 |
| Health Authority: | Japan: Pharmaceuticals and Medical Devices Agency |
Keywords provided by St. Marianna University School of Medicine:
|
Tropical Spastic Paraparesis HAM TSP |
Additional relevant MeSH terms:
|
Bone Marrow Diseases Paraparesis, Spastic Paraparesis, Tropical Spastic Central Nervous System Diseases Central Nervous System Infections Central Nervous System Viral Diseases Deltaretrovirus Infections HTLV-I Infections Hematologic Diseases Myelitis |
Nervous System Diseases Neurologic Manifestations Paraparesis Paresis RNA Virus Infections Retroviridae Infections Signs and Symptoms Spinal Cord Diseases Virus Diseases |
ClinicalTrials.gov processed this record on March 03, 2015