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

Phase 3

Recruiting

• Conditions: HTLV-1 associated myelopathy/tropical spastic paraparesis (HAM/TSP) patients.; Tropical spastic paraplegia; G04.1

• Registration Number: IRCT20180618040127N3
• Lead Sponsor: Mashhad University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 29 November 2021

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 22

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

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.