The safety and effect of Teriflunomide in patients with HTLV-1-induced myelopathy

Evaluation of Teriflunomide’s safety and effect on clinical signs, inflammatory and viral factors in patients with HTLV-1-induced myelopathy

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20180618040127N3

Enrollment

Registered

2021-11-19

Start date

2021-07-06

Completion date

Unknown

Last updated

2021-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HTLV-1 associated myelopathy/tropical spastic paraparesis (HAM/TSP) patients. Tropical spastic paraplegia

Interventions

Intervention 1: Intervention group: Daily administration of one 14-mg tablets of Teriflunomide for 12 months. The drug company is Dr. Abidi. Intervention 2: Control group: Daily administration of one

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Positive serology for Human T-cell Lymphotropic Virus Type-1 (HTLV-1) Occurrence of spastic paraparesia Existence of anti HTLV-1 antibody in cerebrospinal fluid Rule out of other etiologies of spastic paraparesia Motor Disability Grading (MDG) less than 9 Informed consent for participating in the study

Exclusion criteria

Exclusion criteria: Existence of other active and latent infections include of old or active tuberculosis or hepatitis Receiving other drug which influence immune system Severe renal dysfunction Married women of childbearing age who do not use safe contraception

Design outcomes

Primary

Measure	Time frame
Serum level of inflammatory cytokines (TNF-a and NFL) and Viral load. Timepoint: At the begging of study and 12 months later. Method of measurement: Serum level evaluation.	—

Secondary

Measure	Time frame
Medical Research Council (MRC) Scale for Muscle Strength. Timepoint: At the begging of study and months of three, six, nine and twelve. Method of measurement: Physical examination.;Spasticity score with Ashworth scale. Timepoint: At the begging of study and months of three, six, nine and twelve. Method of measurement: Physical examination.;Motor Disability score with Osame Motor Disability Score. Timepoint: At the begging of study and months of three, six, nine and twelve. Method of measurement: Physical examination.;Urinary disturbance score. Timepoint: At the begging of study and months of three, six, nine and twelve. Method of measurement: Physical examination.	—

Measure

Time frame

Medical Research Council (MRC) Scale for Muscle Strength. Timepoint: At the begging of study and months of three, six, nine and twelve. Method of measurement: Physical examination.;Spasticity score with Ashworth scale. Timepoint: At the begging of study and months of three, six, nine and twelve. Method of measurement: Physical examination.;Motor Disability score with Osame Motor Disability Score. Timepoint: At the begging of study and months of three, six, nine and twelve. Method of measurement: Physical examination.;Urinary disturbance score. Timepoint: At the begging of study and months of three, six, nine and twelve. Method of measurement: Physical examination.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. MohammadAli Nahayati

Mashhad University of Medical Sciences

Nahayatia@mums.ac.ir+98 51 3842 9828

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 5, 2026