Evaluation of the Efficacy of Dalfampridine on Walking Impairments in Acute Traumatic Thoracic Spinal Cord Injury

Evaluation of the Effect of Dalfampridine on Walking Impairement of Patients with Acute Thoracic Spinal Cord Injury

Phase III Randomised, superiority, parallel group, triple blind trial on 52 patients. Randomisation was centralised and computerised with concealed randomisation sequence carried out at an external site. https://www.sealedenvelope.com/simple-randomiser/v1/lists

In Shahid Kamyab Hospital of Mashhad, eligible patients will randomly enter into treatment and control groups. All patients receive high-dose methylprednisolone as standard treatment in the first 24 to 48 hours of trauma. The treatment group will take Dalfampridine 10 mg pill twice daily for two months. The control group will take placebo pill in parallel. The primary outcome variables will be measured in 3 times before, one and two months after treatment initiation. Patients will recieve the drug packages randomly, thus none of the participants, researchers, and Data and Safety Monitoring Committee will be aware of the process.

Inclusion criteria: 1. Patients with traumatic thoracic spinal cord injury 2. Age between 18 and 70 years 3. ASIA scale of C or D 4. Glasgow Coma Scale of 15 Exclusion criteria: 1. Any History of Seizures in the Patient 2. Any Contraindications for Dalfampridine Administration 3. Pregnancy 4. Glomerular Filtration Rate below 50

In the treatment group, patients will take Dalfampridine 10 mg pills twice daily in the morning and evening for two months. The control group will also receive placebo pills for two months.

Disability Index; Dynamic Balance Test; 25 Foot Walk Test; American Spinal Injury Association scale; Lower Extremity and Back Visual Analogue Scale; Oswestry Disability Index

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.

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.

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