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

• Status: Unknown status
• Trial end date: 2012-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: St. Marianna University School of Medicine

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.