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Immunomodulatory Agent

Teriflunomide for Tropical Spastic Paraparesis

Phase 1 & 2

Recruiting

Led By Steven Jacobson, Ph.D.

Research Sponsored by National Institute of Neurological Disorders and Stroke (NINDS)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at month 9 and compared to month -3

Awards & highlights

Study Summary

This trial will test the effects of the drug teriflunomide on adults with HAM/TSP. Eligible participants will take the drug once daily for 9 months, and will have various medical tests throughout the 15-month trial.

Who is the study for?

Adults over 18 with HAM/TSP, a rare disease linked to HTLV-1 virus causing lower limb weakness. Participants must be able to take oral meds, follow the trial design, and use reliable birth control if necessary. Excluded are those with severe immune or liver issues, other conditions that could affect results, or recent immunomodulatory drugs usage.Check my eligibility

What is being tested?

The study tests teriflunomide's effectiveness on HAM/TSP by monitoring effects and immune response over 9 months of daily tablet intake. It includes blood/urine tests, lymphapheresis (white cell removal), spinal taps for fluid analysis, and MRI scans of brain/spine.See study design

What are the potential side effects?

Potential side effects of teriflunomide may include liver problems as indicated by screening criteria; however specific side effects are not listed in the provided information but can be similar to those experienced in its current use for multiple sclerosis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at month 9 and compared to month -3

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at month 9 and compared to month -3

This trial's timeline: 3 weeks for screening, Varies for treatment, and at month 9 and compared to month -3 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

ex vivo spontaneous lymphoproliferation in HAM/TSP patients receiving teriflunomide

Secondary outcome measures

Change in 25-foot timed walk

Change in EDSS score

Change in IPEC score

+4 more

Side effects data

From 2015 Phase 4 trial • 1001 Patients • NCT01895335

23%

Alopecia

17%

Diarrhoea

Nausea

Headache

Urinary Tract Infection

Alanine Aminotransferase Increased

Fatigue

Nasopharyngitis

Multiple Sclerosis Relapse

Hypertension

100%

80%

60%

40%

20%

Study treatment Arm

Teriflunomide

Trial Design

1Treatment groups

Experimental Treatment

Group I: TeriflunomideExperimental Treatment1 Intervention

Teriflunomide 14 mg daily

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Teriflunomide

2008

Completed Phase 4

~6190

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

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

1,341 Previous Clinical Trials

649,365 Total Patients Enrolled

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

5 Previous Clinical Trials

1,657 Total Patients Enrolled

Media Library

Teriflunomide (Immunomodulatory Agent) Clinical Trial Eligibility Overview. Trial Name: NCT04799288 — Phase 1 & 2

Hereditary Ataxia Research Study Groups: Teriflunomide

Hereditary Ataxia Clinical Trial 2023: Teriflunomide Highlights & Side Effects. Trial Name: NCT04799288 — Phase 1 & 2

Teriflunomide (Immunomodulatory Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04799288 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this the inaugural study of its type?

"Since its inception in 2014, Teriflunomide has seen a plethora of clinical trials. The initial one was sponsored by Genzyme and featured 166 patients. Thanks to the drug's success during Phase 3 testing it received approval from governing bodies worldwide. Currently there are 13 different studies taking place across 330 cities, spanning 62 countries."

Answered by AI

Are there any openings for participants in this research endeavor?

"The details posted on clinicaltrials.gov suggest that this study is in need of volunteers, having first been made available to the public on September 24th 2021 and last edited October 20th 2022."

Answered by AI

How many individuals have enrolled in this experiment?

"Yes, according to the details presented on clinicaltrials.gov, this experiment is actively seeking participants. Originally posted on September 24th 2021 and most recently updated on October 20th 2022, it seeks 16 patients from a single location."

Answered by AI

Are there any other research investigations that have explored Teriflunomide?

"Currently, 13 distinct clinical studies are in progress to investigate Teriflunomide. 10 of those trials have made it into Phase 3 investigations and 1892 sites nationwide play host for these experiments. Specifically, the majority of research is based out of Charlottesville, Virginia."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Teriflunomide in HTLV-1 Associated Myelopathy/Tropical Spastic Paraparesis

2021. "Teriflunomide in HTLV-1 Associated Myelopathy/Tropical Spastic Paraparesis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04799288.

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