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New treatment option for HAM/TSP
Official title Teriflunomide in HTLV-1 Associated Myelopathy/Tropical Spastic Paraparesis
ClinicalTrials.gov ID: NCT04799288
What this study is testing
What is Teriflunomide?
Teriflunomide is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for ham/tsp.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 15 months
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 120
You may be able to join if
- 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.
You likely can't join if
- 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...
- 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...
- Positive serological evidence of HIV, HTLV-II, Hepatitis B or C
See the full eligibility 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, 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...
- 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...
- 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...
- 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...
- Pregnant or lactating women.
- Treatment with other investigational drugs within 6 months before enrollment
- Known hypersensitivity to teriflunomide or leflunomide
- Concomitant treatment with leflunomide
The study team makes the final eligibility decision.
Where it's taking place
- Bethesda, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 15 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 120 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bethesda, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.