Status unknownNCT01343355Updated Jul 22, 2011

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

A Phase 2/3 interventional study of Tamibarotene in HTLV-I-Associated Myelopathy, sponsored by St. Marianna University School of Medicine. Status unknown at 1 site in Japan. Open to participants aged 30 Years to 75 Years. Per ClinicalTrials.gov, last updated 2011-07-22.

Sponsored by St. Marianna University School of Medicine · Phase 2/3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2011), so the status shown — last known as Active, not recruiting — may be out of date.

Phase: Phase 2/3
Study type: Interventional
Enrollment: 15
Allocation: Not applicable
Ages: 30 Years to 75 Years
Sex: All

Study 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.

Conditions studied

HTLV-I-Associated Myelopathy

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Keywords

Tropical Spastic Paraparesis
HAM
TSP

In context

Paraparesis, Tropical Spastic

21 studies on the registry are indexed under Paraparesis, Tropical Spastic; 2 are open to participants now.

This study's planned enrollment of 15 is below the median of 19 across 15 interventional studies indexed under Paraparesis, Tropical Spastic.

Browse Paraparesis, Tropical Spastic studies →

Lead sponsor

St. Marianna University School of Medicine is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 30 Years to 75 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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.

Study design

Phase: Phase 2 / Phase 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 15 participants (estimated)

Interventions

DrugTamibarotene
Oral administration of tamibarotene 2 mg daily over a period of 12 weeks, then 4mg daily for another 12 weeks.

What researchers measure

Primary outcomes

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

Secondary outcomes

Change in Osame's Motor Disability Score for HAM patients
Time frame: 0, 4, 8, 12, 16, 20, 24, 28 and 32 weeks
Change in The Expanded Disability Status Scale (EDSS)
Time frame: 0, 4, 8, 12, 16, 20, 24, 28 and 32 weeks
Change in timed 10m walk
Time frame: 0, 4, 8, 12, 16, 20, 24, 28 and 32 weeks
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
Change in Modified Ashworth Scale
Time frame: 0, 4, 8, 12, 16, 20, 24, 28 and 32 weeks
Change in Urination function and defecation score
Time frame: 0, 4, 8, 12, 16, 20, 24, 28 and 32 weeks

Study locations

1 site

Iseikai Medical Corporation, Shoyo Kashiwadai Hospital
Kanagawa, 243-0402, Japan

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jul 22, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01343355
Lead sponsor: St. Marianna University School of Medicine
First posted: Apr 28, 2011
Start date: Jan 2011
Primary completion: Mar 2012 (estimated)
Completion: Mar 2012 (estimated)
Last update: Jul 22, 2011

Study contacts

Yoshihisa Yamano, MD

principal investigator · St. Marianna University School of Medicine

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2011. You cannot join it, but the record below documents what was studied.

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