RECRUITING

Teriflunomide in HTLV-1 Associated Myelopathy/Tropical Spastic Paraparesis

Conditions

HAM/TSP Aubagio Single center Open Label

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-09-24

Study Completion:2025-08-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04799288

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 120 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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, or completion of latent tuberculosis infection treatment, per CDC and National TB Controllers Association recommendations in the event of a positive test result * 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.	* 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 * \<= 10 mg of prednisone usage within three months prior to administration of study drug. * Pregnant or lactating women. * Treatment with other investigational drugs within 6 months before enrollment * Known hypersensitivity to teriflunomide or leflunomide * Concomitant treatment with leflunomide

Inclusion Criteria

Exclusion 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, or completion of latent tuberculosis infection treatment, per CDC and National TB Controllers Association recommendations in the event of a positive test result
* 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.

* 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
* \<= 10 mg of prednisone usage within three months prior to administration of study drug.
* Pregnant or lactating women.
* Treatment with other investigational drugs within 6 months before enrollment
* Known hypersensitivity to teriflunomide or leflunomide
* Concomitant treatment with leflunomide

Contacts and Locations

Study Contact

William R Frazier, M.D.

CONTACT

(301) 496-1801

william.frazier@nih.gov

Steven Jacobson, Ph.D.

CONTACT

(301) 496-0519

jacobsons@ninds.nih.gov

Principal Investigator

Steven Jacobson, Ph.D.

PRINCIPAL_INVESTIGATOR

National Institute of Neurological Disorders and Stroke (NINDS)

Study Locations (Sites)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892

United States

Collaborators and Investigators

Sponsor: National Institute of Neurological Disorders and Stroke (NINDS)

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-09-24

Study Completion Date2025-08-31

Study Record Updates

Study Start Date2021-09-24

Study Completion Date2025-08-31

Terms related to this study

Keywords Provided by Researchers

Aubagio
Single center
Open Label

Additional Relevant MeSH Terms

HAM/TSP