Actively Recruiting
Teriflunomide in HTLV-1 Associated Myelopathy/Tropical Spastic Paraparesis
Led by National Institute of Neurological Disorders and Stroke (NINDS) · Updated on 2026-03-11
24
Participants Needed
1
Research Sites
431 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Background: HTLV-1 associated myelopathy/tropical spastic paraparesis (HAM/TSP) is a rare, progressive disease. It occurs in some people infected with the HTLV-1 virus. It leads to weakness in the lower limbs and other serious problems. It has no treatment. Teriflunomide is a drug used to treat multiple sclerosis. It reduces immune cells that make the disease worse. Researchers want to learn if this drug can help people with HAM/TSP. Objective: To learn the effects, immune response, safety, and tolerability of teriflunomide in people with HAM/TSP. Eligibility: Adults ages 18 and older with HAM/TSP. Design: Participants will be screened under protocol 98-N-0047. Participants will have a medical history. They will have physical and neurological exams. They will have blood and urine tests. Participants will take 1 tablet of the study drug once a day for 9 months. They will keep a drug diary. Participants will have lymphapheresis. For this, blood is drawn from a needle in one arm. A machine divides the blood into red cells, plasma, and white cells. The white cells are removed. The plasma and red cells are returned to the participant through a needle in the other arm. Participants will have lumbar punctures ( spinal taps ). For this, a thin needle is inserted into the spinal canal in the lower back. Spinal fluid is removed. Participants will have magnetic resonance imaging (MRI) of the brain and spine. The MRI scanner is a metal cylinder surrounded by a strong magnetic field. During the MRI, participants will lie on a table that can slide in and out of the scanner. Participation will last for 15 months.
CONDITIONS
Official Title
Teriflunomide in HTLV-1 Associated Myelopathy/Tropical Spastic Paraparesis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years or older
- Diagnosis of HAM/TSP as defined by WHO criteria with positive HTLV-1 EIA and confirmatory Western Blot
- Enrollment in protocol 98-N-0047
- Willingness and ability to comply with trial design and follow-up
- Negative QuantiFERON-TB gold test or completed latent tuberculosis infection treatment according to CDC guidelines
- Repeated indeterminate QuantiFERON-TB tests require chest x-ray to rule out latent TB infection
- Ability to take oral medication and adhere to protocol
- Ability to provide informed consent
- Commitment to use reliable birth control during treatment and for two years after if able to become pregnant or father a child
You will not qualify if you...
- Alternative diagnoses explaining neurological disability
- Conditions, therapies, or lab abnormalities that may interfere with trial participation or results
- Severe immunodeficiency, bone marrow disease, or severe uncontrolled infections
- Liver dysfunction with AST or ALT greater than twice the upper limit of normal
- Positive serology for HIV, HTLV-II, Hepatitis B or C
- Immunomodulatory or immunosuppressive therapy except topical steroids or prednisone ≤10 mg/day discontinued at least 3 months before enrollment
- Pregnant or lactating women
- Use of other investigational drugs within 6 months before enrollment
- Known hypersensitivity to teriflunomide or leflunomide
- Concurrent treatment with leflunomide
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
C
Christopher Y Itoh, M.D.
CONTACT
S
Steven Jacobson, Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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