Teriflunomide in HTLV-1 Associated Myelopathy/Tropical Spastic Paraparesis

Conditions

• HAM/TSP

Eligibility Criteria

Sex

ALL

Age

18 Years - 120 Years

Healthy Volunteers

Not accepted

Interventions

• Teriflunomide — DRUG
  Teriflunomide 14mg will be administered orally as 1 tablet once daily during the 9-month treatment phase of the study.

Study Details

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.

Key Dates

Start date

Sep 24, 2021

Status verified

Mar 2026

Primary completion

Dec 31, 2027

Completion

Dec 31, 2029

Study Design

Enrollment

24 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Teriflunomide
  Teriflunomide 14 mg daily

Primary Outcome Measure

ex vivo spontaneous lymphoproliferation in HAM/TSP patients receiving teriflunomide [ Time Frame: Percent change between Day 0 and month 9 of spontaneous proliferation. ]

Central Contacts

• Christopher Y Itoh, M.D.
  (000) 000-0000
  [email protected]
• Steven Jacobson, Ph.D.
  (301) 496-0519
  [email protected]

Locations (1)

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