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IRCT20231019059767N1 IRCT 2024-01-17 Mashhad University of Medical Sciences Effect of Dalfampridine in Treatment of Spinal Cord Injury Evaluation of the Efficacy of Dalfampridine on Walking Impairments in Acute Traumatic Thoracic Spinal Cord Injury 2024-01-20 anticipated 52 Complete https://irct.ir/trial/73794 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, blocking will be used as a reliable randomization method that leads to the balanced allocation of people in treatment groups at the end of each block. The website - https://www.sealedenvelope.com/simple-randomiser/v1/lists is used to prepare random blocks with variable sizes. The output of the site is such that, depending on the number of samples and the proposed sizes of the blocks, a specific number of blocks with different sizes (4 and 6) and with different sequences of block content is provided, which is followed by the content of each block in a sealed envelope. And when patients visit, one of the blocks is randomly selected and depending on the sequence of its content, the person in question is placed in one of the arms of the study. In the same way, after the completion of the first block, the second block is randomly selected and this continues until the last block and assigning the last person to the study arms. As a rule, by assigning the last sheet of the last block, the patients are grouped equally in the two arms of the study and the balance between the groups is established, Blinding description: In this thriple-blind study, patients will be divided into A and B groups through block randomization method. The drug and placebo are divided into two separate groups A and B by a person who is not involved in the study process. The contents of these two groups will remain in the sealed envelope until the end of the study. Within the first visit of the patient, a block will be randomly choosen. Based on the revealed content, patient will be included in group A or B and then will recieve his/her own corresponding drug. Dalfampridine and placebo tablets are both produced and packaged by the same company and completely similar in shape, color, smell and other characteristics. Also, the time and route of administration is similar. In this way, the participants, researcher, health personnel, data collectors, data evaluators, and the Safety and Data Monitoring Committee will not be aware of the allocation of patients to the study groups until end of the study. 3 Thoracic Spinal Cord Injury. Intervention 1: Intervention group: In the intervention group, patients after spinal cord injury receive routine high-dose Prednisolone treatment for 24 to 48 hours. Thereafter patients take Dalfampridine 10 mg tablets of Zist Orchid Pharmed company daily in the morning and evening for 2 months. In this way, the first dose is taken before breakfast and the second dose is taken 12 hours after that. The primary and secondary outcome variables are examined on 3 occasions before the intervention and one month and two months after the intervention. The content of Dalfampridine tablets includes 10 miligram of the main active ingredient Dalfampridine and other ingredients such as Hydroxypropyl methyl cellulose, Microcrystalline cellulose, Colloidal silicon dioxide, Magnesium stearate, Talc powder, and Sodium lauryl sulfate. Intervention 2: Control group: In the control group, patients after spinal cord injury receive routine high-dose Prednisolone treatment for 24 to 48 hours. After that, the patients take the placebo tablets prepared by Zist Orchid Pharmed company daily in the morning and evening for 2 months. In this way, the first dose is taken before breakfast and the second dose is taken 12 hours after that. The primary and secondary outcome variables are examined on 3 occasions before the intervention and one month and two months after the intervention. The content of the placebo tablets includes all the items of the main drug except the active ingredient Dalfampridine, which includes Hydroxypropyl methyl cellulose, Microcrystalline cellulose, Colloidal cilicon dioxide, Magnesium stearate, Talc powder, and Sodium lauryl sulfate. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Babak Ganjeifar
Department of neurosurgery, Ghaem hospital, Ahmadabad Blvd, Mashhad
Mashhad Iran (Islamic Republic of) 9176699199 +98 51 3841 3493 b.ganjeifar@gmail.com Mashhad University of Medical Sciences scientific Mohammadali Nahayati
Department of neurology, Ghaem hospital, Ahmadabad Blvd, Mashhad
Mashhad Iran (Islamic Republic of) 9176699199 +98 51 3841 3493 Nahayatia@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) All Patients with Traumatic Thoracic Spinal Cord Injury Patients with ASIA Scale C or D Patients without any Contraindications for Dalfampridine Prescription Patients having 18 to 70 Years of Age Patients who have GCS 15 18 years 70 years Both Any History of Seizure in Patient Pregnancy GFR Lower than 50 ml/min T09.3 Injury of spinal cord, level unspecified Treatment - Drugs Placebo Intervention group: In the intervention group, patients after spinal cord injury receive routine high-dose Prednisolone treatment for 24 to 48 hours. Thereafter patients take Dalfampridine 10 mg tablets of Zist Orchid Pharmed company daily in the morning and evening for 2 months. In this way, the first dose is taken before breakfast and the second dose is taken 12 hours after that. The primary and secondary outcome variables are examined on 3 occasions before the intervention and one month and two months after the intervention. The content of Dalfampridine tablets includes 10 miligram of the main active ingredient Dalfampridine and other ingredients such as Hydroxypropyl methyl cellulose, Microcrystalline cellulose, Colloidal silicon dioxide, Magnesium stearate, Talc powder, and Sodium lauryl sulfate. Control group: In the control group, patients after spinal cord injury receive routine high-dose Prednisolone treatment for 24 to 48 hours. After that, the patients take the placebo tablets prepared by Zist Orchid Pharmed company daily in the morning and evening for 2 months. In this way, the first dose is taken before breakfast and the second dose is taken 12 hours after that. The primary and secondary outcome variables are examined on 3 occasions before the intervention and one month and two months after the intervention. The content of the placebo tablets includes all the items of the main drug except the active ingredient Dalfampridine, which includes Hydroxypropyl methyl cellulose, Microcrystalline cellulose, Colloidal cilicon dioxide, Magnesium stearate, Talc powder, and Sodium lauryl sulfate. 25-Foot Walk Test. Timepoint: At the beginning of study (Before Treatment), 30, and 60 days after initiation of treatment. Method of measurement: Chronometer watch. Dynamic Balance Test. Timepoint: At the beginning of study (Before Treatment), 30, and 60 days after initiation of treatment. Method of measurement: Chronometer watch. Disability Index. Timepoint: At the beginning of study (Before Treatment), 30, and 60 days after initiation of treatment. Method of measurement: Disability Index Questionnare. American Spinal Injury Association Impairment Scale. Timepoint: At the beginning of study (Before Treatment), 30, and 60 days after initiation of treatment. Method of measurement: American Spinal Injury Association Impairment Scale chart. Oswestry Disability Index. Timepoint: At the beginning of study (Before Treatment), 30, and 60 days after initiation of treatment. Method of measurement: Oswestry Disability Questionnaire. Lower Extremity Pain Visual Analogue Scale. Timepoint: At the beginning of study (Before Treatment), 30, and 60 days after initiation of treatment. Method of measurement: Visual Analogue Scale Diagram. Back Pain Visual Analogue Scale. Timepoint: At the beginning of study (Before Treatment), 30, and 60 days after initiation of treatment. Method of measurement: Visual Analogue Scale Diagram. Zist Orchid Pharmed Zist Orchid Pharmed Zist Orchid Pharmed Approved 2023-07-18 Research Ethics Committees of School of Medicine- Mashhad University of Medical Sciences Qoreishi building., Daneshghah Ave., Mashhad., Khorasan Razavi Mashhad Razavi Khorasan Iran (Islamic Republic of)