Trial · NCT04799288
Teriflunomide in HTLV-1 Associated Myelopathy/Tropical Spastic Paraparesis
NCT04799288, Phase 1, Phase 2, Recruiting, National Institute of Neurological Disorders and Stroke (NINDS)
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Teriflunomide in HTLV-1 Associated Myelopathy/Tropical Spastic Paraparesis. Trials, record NCT04799288. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04799288
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Teriflunomide in HTLV-1 Associated Myelopathy/Tropical Spastic Paraparesis
- NCT number
- NCT04799288
- Status
- Recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 24 participants, estimated
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)
- Conditions
- HAM/TSP
- Interventions
- Teriflunomide
- First posted
- 2021-03-16
- Last updated
- 2026-11-12
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | ex vivo spontaneous lymphoproliferation in HAM/TSP patients receiving teriflunomide | Percent change between Day 0 and month 9 of spontaneous proliferation. | ex vivo spontaneous lymphoproliferation of HAM/TSP patients receiving teriflunomide and multicolor flow cytometric analysis of immune activation markers in both PBMCs and CSF |
| Secondary | Tabulation of adverse events | at each visit | This is a first in HAM/TSP pilot study using teriflunomide thus important to monitor for any unexpected events related to worsening of disease laboratory and clinical measures. |
| Secondary | Percent change between CD8+ and CD4+ cells in the CSF | between month -3 and month 9 | CD8 cells are thought to be immunopathogenic and drive the immune response. In vitro studies have shown a reduction of CD8+ and CD4+ cells in the presences of teriflunomide. |
| Secondary | HTLV-1 proviral load in the peripheral blood mononuclear cells (PBMCs) | at month 9 and compared to Day 0 | HTLV-1 proviral load is a measure of the percent of infected cells and previous data suggests a correlation with disease activity. |
| Secondary | HTLV-1 proviral load in the CSF cells | at month 9 and compared to month -3 | HTLV-1 proviral load is a measure of the percent of infected cells and previous data suggests a correlation with disease activity. |
| Secondary | Change in IPEC score | at month 9 and compared to Day 0 | This is a first in HAM/TSP pilot study using teriflunomide thus important to monitor for any unexpected events related to worsening of clinical measures. |
| Secondary | Change in EDSS score | at month 9 and compared to Day 0 | This is a first in HAM/TSP pilot study using teriflunomide thus important to monitor for any unexpected events related to worsening of clinical measures. |
| Secondary | Change in 25-foot timed walk | at month 9 and compared to Day 0 | This is a first in HAM/TSP pilot study using teriflunomide thus important to monitor for any unexpected events related to worsening of clinical measures. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04799288
GET https://conductscience.org/api/trials/v1/NCT04799288/registered