Trial record 2 of 17 for:    Tropical Spastic Paraparesis

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
Sponsor:
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
  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 April 21, 2014