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Teriflunomide in HTLV-1 Associated Myelopathy/Tropical Spastic Paraparesis

StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 263 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Minor Eligibility criteria expanded, about 21 words Secondary endpoints: details revised at 5 of 7 entries Show 1 more changeShow less
    • Secondary endpoints: details revised at 5 of 7 entries
  2. Minor 4 versions Re-verified since Dec 19, 2025, no change to tracked fieldsv259-v262
  3. Minor Primary completion date: Aug 31, 2027 to Dec 31, 2027 Completion date: Aug 31, 2027 to Dec 31, 2029v258 Show 1 more changeShow less
    • Completion date: Aug 31, 2027 to Dec 31, 2029
  4. Minor 3 versions Re-verified since Aug 23, 2025, no change to tracked fieldsv255-v257
  5. Notable Primary and study completion dates: Aug 31, 2025 to Aug 31, 2027v254
Show 40 earlier versionsHide 40 earlier versions
  1. Minor 8 versions Re-verified since Feb 19, 2025, no change to tracked fieldsv246-v253
  2. Minor Eligibility criteria expanded, about 59 wordsv245 See this version in full on ClinicalTrials.gov ↗
  3. Minor 4 versions Re-verified since Apr 18, 2024, no change to tracked fieldsv241-v244
  4. Minor Eligibility criteria expanded, about 25 wordsv240 See this version in full on ClinicalTrials.gov ↗
  5. Minor 5 versions Re-verified since May 11, 2023, no change to tracked fieldsv235-v239
  6. Minor Eligibility criteria expanded, about 48 wordsv234 See this version in full on ClinicalTrials.gov ↗
  7. Minor 3 versions Re-verified since Jan 25, 2023, no change to tracked fieldsv231-v233
  8. Notable Enrollment target: 16 to 24v230
  9. Notable Primary and study completion dates: Jun 30, 2024 to Aug 31, 2025v229
  10. Minor 4 versions Re-verified since Aug 4, 2022, no change to tracked fieldsv225-v228
  11. Minor Study Status, Outcome Measures, Eligibility, Contacts/Locations, IPDSharingv224
  12. Minor 10 versions Re-verified since Jun 21, 2022, no change to tracked fieldsv214-v223
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04799288
Lead Sponsor National Institute of Neurological Disorders and Stroke (NINDS)
Conditions HAM/TSP
Enrollment 24 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov