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IRCT20180618040127N4 IRCT 2023-06-08 Mashhad University of Medical Sciences The effect of Dalfampridine in HTLV-1 patients The effect of Dalfampridine on dysfunction of walking in patients with HTLV-1-induced myelopathy 2023-06-21 anticipated 40 Complete https://irct.ir/trial/38547 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 numbers from one to forty. These numbers are defined as placebo and main drug in the pre-prepared tables with the main analyzer. In addition, the numbers and medicines have been randomly drawn by the main analyzer. we have 40 patients that are divided into two groups(ie, pill drug and placebo) thus we select 40 numbers (ie, 01to 40) witch 20 belong to cases and 20 numbers belong to control. we write the name case or control on the paper and put on of them into an open box and 40 patients incidentally pick 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 01 to 40 and delivered to the main analyzer. At the end of the study, these numbers are decoded. 3 HTLV-1 associated myelopathy/tropical spastic paraparesis (HAM/TSP) patients. Intervention 1: Intervention group: Daily administration of two10-mg capsules ofDalfampridine for 2 months. The drug company is Zahravi,. Intervention 2: Control group: Control group: Daily administration of 2 placebo (capsules in same color and shape with intervention group) for 2 months. 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. Reza Boostani
Before Shariati Square, Ahmadabad Street, Qaem Hospital
Mashhad Iran (Islamic Republic of) ٩٩١٩١ ٩١٧٧٨ +98 51 3842 9828 Boostanir@Mums.ac.ir Mashhad University of Medical Sciences scientific Dr. Reza Boostani
Before Shariati Square, Ahmadabad Street, Qaem Hospital
Mashhad Iran (Islamic Republic of) ٩٩١٩١ ٩١٧٧٨ +98 51 329828 Boostanir@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 18 years 60 years Both Existence of other active and latent infections Receiving other drug which influence immune system Existence of any history of seizures or epilepsy or other seizure disorders G04.1 Tropical spastic paraplegia Treatment - Drugs Treatment - Drugs Intervention group: Daily administration of two10-mg capsules ofDalfampridine for 2 months. The drug company is Zahravi, Control group: Control group: Daily administration of 2 placebo (capsules in same color and shape with intervention group) for 2 months. Medical Research Council (MRC) Scale for Muscle Strength. Timepoint: At the begging of study and months of 1 and 2. Method of measurement: Physical examination. Spasticity score with Ashworth scale. Timepoint: At the begging of study and months of 1 and 2. Method of measurement: Physical examination. Motor Disability score with Osame Motor Disability Score. Timepoint: At the begging of study and months of 1 and 2. Method of measurement: Physical examination. T25FW:Timed 25 foot walk. Timepoint: At the begging of study and months of 1 and 2. Method of measurement: Physical examination. Mashhad University of Medical Sciences Approved 2019-11-22 Ethics committee of َMashhad University of Medical Sciences Opposite Daneshgah 18, Daneshgah Avenue, Central bulding of Mashhad University of Medical Sciences (Ghoreishi) Mashhsd Razavi Khorasan Iran (Islamic Republic of)