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Teriflunomide for HTLV-1 Associated Myelopathy/Tropical Spastic Paraparesis

This study is looking into whether Teriflunomide, a drug used for multiple sclerosis, can help people with HTLV-1 Associated Myelopathy/Tropical Spastic Paraparesis (HAM/TSP). HAM/TSP is a rare, progressive disease that causes weakness and other serious problems, and currently has no treatment. Researchers want to understand the effects, immune response, safety, and how well people tolerate Teriflunomide. You may be able to join if you are an adult aged 18 or older with a confirmed diagnosis of HAM/TSP. The main goal is to see how Teriflunomide affects certain immune cells (lymphoproliferation) in HAM/TSP patients over nine months.

Study design
This is a single-arm, open-label pilot study with 16 participants. It will compare participants' health before and after receiving Teriflunomide.
What's involved
You would take Teriflunomide 14mg by mouth once daily for nine months. Outcome measures will be collected every three months during the study.
Compensation
Not stated in the trial record.
Follow-up
After the nine-month treatment phase, there will be a three-month post-treatment follow-up phase.

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NCT04799288

Teriflunomide in HTLV-1 Associated Myelopathy/Tropical Spastic Paraparesis

Recruiting
PHASE1Ages 18+InterventionalTreatment
National Institute of Neurological Disorders and Stroke (NINDS)
~24 participants
Updated 2026-06-22 on ClinicalTrials.gov
What's tested:Teriflunomide

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
ex vivo spontaneous lymphoproliferation in HAM/TSP patients receiving teriflunomide
Measured over Percent change between Day 0 and month 9 of spontaneous proliferation.

Conditions

HAM/TSP

Explore related trials

HTLV-1 Associated MyelopathyHTLV-1 Infection

Where it's being run

1 sites across 1 states
Maryland1

Study leadership

  • Steven Jacobson, Ph.D. · PRINCIPAL_INVESTIGATOR · National Institute of Neurological Disorders and Stroke (NINDS)

Who to contact

Christopher Y Itoh, M.D.
[email protected]
(000) 000-0000
Email the study team

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Eligibility criteria

Inclusion

18 years or older
Diagnosis of HAM/TSP as defined by WHO criteria, including a positive HTLV-1 EIA and confirmatory Western Blot.
Enrolled in 98-N-0047
Patient must be willing and able to comply with all the aspects of trial design and follow-up.
Negative QuantiFERON-TB gold, or completion of latent tuberculosis infection treatment, per CDC and National TB Controllers Association recommendations in the event of a positive test result
In the event of an indeterminant result, the test will be repeated. Should two consecutive tests yield indeterminant results, a chest x-ray will be performed to rule out radiographic evidence of a latent TB infection. Negative imaging will enable the subject to qualify for participation in the study.
Ability to take oral medication and be willing to adhere to the protocol regimen
Patients must be able to provide informed consent
If able to become pregnant or to father a child, patient must agree to commit to the use of a reliable/accepted method of birth control (i.e. hormonal contraception (birth control pills, injected hormones, vaginal ring), intrauterine device, barrier methods with spermicide (diaphragm with spermicide, condom with spermicide) or surgical sterilization (hysterectomy, tubal ligation, or vasectomy) for the duration of the treatment arm of the study and for two years following cessation of treatment with teriflunomide.

Exclusion

Alternative diagnoses that can explain neurological disability
History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial or interfere with participation for the full duration of the trial; or not in the best interest of the subject to participate, in the opinion of the treating investigator
Severe immunodeficiency, bone marrow disease, or severe, uncontrolled infections.
Liver dysfunction, as indicated by baseline aspartate aminotransferase (AST) or alanine or alanine aminotransferase (ALT) greater than 2 times the upper limit of normal
Positive serological evidence of HIV, HTLV-II, Hepatitis B or C
Treatment with immunomodulatory/immunosuppressive therapy is exclusionary except in the cases below:
current use of topical steroids
Study participants who have been prescribed \<= 10 mg prednisone (PO) per day will be required to discontinue this medication for a period of at least 3 months (90 days) prior to enrolling in 21-N-0016. Additionally, participants who have been prescribed burst therapy with an oral steroid as an outpatient over the course of \<= 10 days (e.g., Medrol Dosepak \[methylprednisolone\]), can enroll after discontinuing burst dose oral steroids for at least 3 months.
Pregnant or lactating women.
Treatment with other investigational drugs within 6 months before enrollment
Known hypersensitivity to teriflunomide or leflunomide
Concomitant treatment with leflunomide

What this trial measures

  • ex vivo spontaneous lymphoproliferation in HAM/TSP patients receiving teriflunomidePercent change between Day 0 and month 9 of spontaneous proliferation.

    ex vivo spontaneous lymphoproliferation of HAM/TSP patients receiving teriflunomide and multicolor flow cytometric analysis of immune activation markers in both PBMCs and CSF