Teriflunomide in HTLV-1 Associated Myelopathy/Tropical Spastic Paraparesis
Status:
Recruiting
Trial end date:
2022-12-31
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
National Institute of Neurological Disorders and Stroke (NINDS)