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Protocol Details

Phase I/II Study of Teriflunomide in HTLV-1 Associated Myelopathy/Tropical Spastic Paraparesis

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

21-N-0016

Sponsoring Institute

National Institute of Neurological Disorders and Stroke (NINDS)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18
Max Age: N/A

Referral Letter Required

No

Population Exclusion(s)

Children

Special Instructions

Currently Not Provided

Keywords

Aubagio;
Single center;
Open Label

Recruitment Keyword(s)

None

Condition(s)

HAM/TSP

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

Drug: Teriflunomide

Supporting Site

National Institute of Neurological Disorders and Stroke

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.

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Eligibility

INCLUSION CRITERIA:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

-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

-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 CRITERIA:

An individual who meets any of the following criteria will be excluded from participation in this study:

-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 (aside from topical steroids) in the preceding 6 months.


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

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



Joan M. Ohayon, C.R.N.P.
National Institute of Neurological Disorders and Stroke (NINDS)
BG 10 RM 5C442
10 CENTER DR
BETHESDA MD 20814
(301) 496-3825
eatonj@ninds.nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: 1-866-411-1010
PRPL@cc.nih.gov

Clinical Trials Number:

NCT04799288

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