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Efficacy and Safety of Tamibarotene(AM80H) for HTLV-1 Associated Myelopathy/ Tropical Spastic Paraparesis (HAM/TSP)

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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
Sponsor:
Information provided by:
St. Marianna University School of Medicine

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
HTLV-I-Associated Myelopathy Drug: Tamibarotene Phase 2 Phase 3

Study Design
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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

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Arms and Interventions
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Intervention Details:
  • Drug: Tamibarotene
    Oral administration of tamibarotene 2 mg daily over a period of 12 weeks, then 4mg daily for another 12 weeks.

Outcome Measures
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Primary Outcome Measures :
  1. Change in Soluble IL-2 Receptor level in peripheral blood [ Time Frame: 0, 4, 8, 12, 16, 20, 24, 28 and 32 weeks ]
  2. Change in HTLV-I viral load in peripheral blood [ Time Frame: 0, 4, 8, 12, 16, 20, 24, 28 and 32 weeks ]
  3. Change in T cell population in peripheral blood [ Time Frame: 0,12, 24, 28 and 32 weeks ]
  4. Change in cerebrospinal fluid examination [ Time Frame: baseline and after the treatment defined as from 24 to 32 weeks ]

Secondary Outcome Measures :
  1. Change in Osame's Motor Disability Score for HAM patients [ Time Frame: 0, 4, 8, 12, 16, 20, 24, 28 and 32 weeks ]
  2. Change in The Expanded Disability Status Scale (EDSS) [ Time Frame: 0, 4, 8, 12, 16, 20, 24, 28 and 32 weeks ]
  3. Change in timed 10m walk [ Time Frame: 0, 4, 8, 12, 16, 20, 24, 28 and 32 weeks ]
  4. 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 ]
  5. Change in Modified Ashworth Scale [ Time Frame: 0, 4, 8, 12, 16, 20, 24, 28 and 32 weeks ]
  6. Change in Urination function and defecation score [ Time Frame: 0, 4, 8, 12, 16, 20, 24, 28 and 32 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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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Information from the National Library of Medicine

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


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
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Additional Information:
HTLV-1 Information for Japanese  This link exits the ClinicalTrials.gov site

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