Trial record 2 of 16 for:
Tropical Spastic Paraparesis
Efficacy and Safety of Tamibarotene(AM80H) for HTLV-1 Associated Myelopathy/ Tropical Spastic Paraparesis (HAM/TSP)
This study is ongoing, but not recruiting participants.
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:
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
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:
|
Paraparesis, Tropical Spastic Paraparesis, Spastic Paraparesis Bone Marrow Diseases Spinal Cord Diseases Hematologic Diseases Central Nervous System Diseases Nervous System Diseases Myelitis Central Nervous System Viral Diseases Virus Diseases HTLV-I Infections |
Deltaretrovirus Infections Retroviridae Infections RNA Virus Infections Central Nervous System Infections Paresis Neurologic Manifestations Signs and Symptoms Benzoates Antifungal Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013