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IRCT20180618040127N3 IRCT 2021-11-19 Mashhad University of Medical Sciences 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 2021-07-06 anticipated 22 Complete https://irct.ir/trial/50109 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Depending on the time of arrival of patients in the study, the patient randomly selects one of the letters of the English alphabet from A to V. These letters are defined as placebo and main drug in the pre-prepared tables with the main analyzer. In addition, the order of English letters and medicines has been randomly drawn by the main analyzer. we have 22 patients that divided into two groups(ie, pill drug and placebo) thus we select 22 English alphabetic words (ie, A to V) witch 11 words belong to cases and 11 words belong to control. we write the name case or control on the paper and put on of them into an open box and 22 patients incidentally pick of them and they don't see the result and they give that paper to us, Blinding description: According to the explanations given in the way of randomization and with the coordination of the drug manufacturer, the coating and packaging form of the placebo and the drug are considered the same and are coded as A to V and delivered to the main analyzer. At the end of the study, these letters of the alphabet a to v are decoded. 3 HTLV-1 associated myelopathy/tropical spastic paraparesis (HAM/TSP) patients. 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 placebo (tablet in same color and shape with intervention group) for 12 months. The placebo company is Dr. Abidi. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Dr. MohammadAli Nahayati
Before Shariati Square, Ahmadabad Street, Qaem Hospital
Mashhad Iran (Islamic Republic of) 99199-91766 +98 51 3842 9828 Nahayatia@mums.ac.ir Mashhad University of Medical Sciences scientific Dr. MohammadAli Nahayati
Before Shariati Square, Ahmadabad Street, Qaem Hospital
Mashhad Iran (Islamic Republic of) 99199-91766 +98 51 3842 9828 nahayatia@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) 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 no limit no limit Both 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 G04.1 Tropical spastic paraplegia Treatment - Drugs Treatment - Drugs Intervention group: Daily administration of one 14-mg tablets of Teriflunomide for 12 months. The drug company is Dr. Abidi. Control group: Daily administration of one placebo (tablet in same color and shape with intervention group) for 12 months. The placebo company is Dr. Abidi. 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. 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. Mashhad University of Medical Sciences Approved 2020-07-21 Ethics committee of َMashhad University of Medical Sciences Opposite Daneshgah 18, Daneshgah Avenue, Central bulding of Mashhad University of Medical Sciences (Ghoreishi) Mashhad Razavi Khorasan Iran (Islamic Republic of)