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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
No Placebo-Only Group

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.
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.
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 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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
ex vivo spontaneous lymphoproliferation in HAM/TSP patients receiving teriflunomide
Secondary study objectives
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
8%
Nausea
7%
Headache
6%
Urinary Tract Infection
6%
Alanine Aminotransferase Increased
5%
Fatigue
5%
Nasopharyngitis
2%
Multiple Sclerosis Relapse
1%
Hypertension
100%
80%
60%
40%
20%
0%
Study treatment Arm
Teriflunomide

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
~7100

Find a Location

Who is running the clinical trial?

National Institute of Neurological Disorders and Stroke (NINDS)Lead Sponsor
1,378 Previous Clinical Trials
652,168 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
~5 spots leftby Aug 2025
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