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IRCT20190324043105N1 IRCT 2019-04-26 Esfahan University of Medical Sciences Effect of Edaravone in treatment of ALS Isfahan ALS Registery Evaluation of the effectiveness of Edaravone compared with placebo in maintaining muscle strength, functional status, and quality of life in patients with amyotrophic lateral sclerosis 2017-03-16 anticipated 20 Complete https://irct.ir/trial/38500 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients entering the study will be divided into two groups of case and control by simple randomization technique (using statistical software). The unit of randomization will be "individual". After patients entered the study, each one will be numbered from 1 to 20. Then, "random number generator" software, will generate 10 random numbers from 1 to 20. Patients with equal numbers to random numbers will enter to the case group, and the other patients will enter to the control group. 2-3 Amyotrophic Lateral Sclerosis. Intervention 1: Intervention group: Riluzule + Edaravone; In this group, patients treated with Iranian Riluzule (Rilumax 50 mg tablet, tehrandarou Pharma Corporation) and Edaravone (60 mg Radicut vial, Mitsubishi Tanabe Pharma Corporation, Japan). During the study period, patients will administer 50 mg Riluzule tablet every 12 hours orally. 60 mg Edaravone vial will be diluted in 100 ml of normal saline and then patients will administer Edaravone via slow intravenous infusion. Edaravone will be prescribed in 4-week cycles. In the first cycle, patients will only inject the drug within the first 14 days. In the next 11 cycles, patients will only inject the drug within the first 10 days. Intervention 2: Control group: Riluzule + Placebo (normal saline); In this group, patients treated with Iranian Riluzule (Rilumax 50 mg tablet, tehrandarou Pharma Corporation) and Placebo (normal saline). During the study period, patients will administer 50 mg Riluzule tablet every 12 hours orally. as the placebo 100 ml of normal saline via slow intravenous infusion will be injected. normal saline will be injected in 4-week cycles. In the first cycle, patients will only inject the placebo within the first 14 days. In the next 11 cycles, patients will only inject the placebo within the first 10 days. Yes - There is a plan to make this available What will be shared: after finishing this trial, MMT, ALSFRS-R, and ALSAQ-40 scores of all patients will be shared with all researchers . When: starting 6 months after publication To whom: people working in academic institutions Conditions: the deidentified individual participant data will be available only for research purposes. Where to obtain: alireza.eishi@yahoo.com How to obtain: by sending his/her request to mentioned Email, within less than a month: alireza.eishi@yahoo.com Comments:
public Alireza Eishi Oskouei
EMG Department, Alzahra University Hospital, Soffeh Blvd., Isfehan
Isfehan Iran (Islamic Republic of) 8174675731 +98 31 3620 2020 alireza.eishi@yahoo.com Esfahan University of Medical Sciences scientific Keivan Basiri
EMG Department, Alzahra University Hospital, Soffeh Blvd., Isfehan
Isfehan Iran (Islamic Republic of) 8174675731 +98 31 3620 2020 basiri.keivan@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Patients diagnosed as definite or probable ALS disease according to El Escorial Criteria ALS patients who are graded as mild or moderate according to ALS Health State Scale. The patient gets at least 2 points on all 12 items of the ALSFRS-R. Forced vital capacity of at least 80% in spirometry. Desire of the patient to participate in this study and Signing Written Informed Consent. 18 years 75 years Both Patients diagnosed as possible ALS disease according to El Escorial Criteria ALS patients who are graded as severe or terminal according to ALS Health State Scale. The patient can't get at least 2 points on all 12 items of the ALSFRS-R. The patient administers another drug or herb for ALS treatment. Unwillingness of patient to enter the clinical trial G12.21 Progressive muscular atrophy; Restrictive lung disease due to amyotrophic lateral sclerosis; Restrictive lung mechanics due to als Treatment - Drugs Treatment - Drugs Intervention group: Riluzule + Edaravone; In this group, patients treated with Iranian Riluzule (Rilumax 50 mg tablet, tehrandarou Pharma Corporation) and Edaravone (60 mg Radicut vial, Mitsubishi Tanabe Pharma Corporation, Japan). During the study period, patients will administer 50 mg Riluzule tablet every 12 hours orally. 60 mg Edaravone vial will be diluted in 100 ml of normal saline and then patients will administer Edaravone via slow intravenous infusion. Edaravone will be prescribed in 4-week cycles. In the first cycle, patients will only inject the drug within the first 14 days. In the next 11 cycles, patients will only inject the drug within the first 10 days. Control group: Riluzule + Placebo (normal saline); In this group, patients treated with Iranian Riluzule (Rilumax 50 mg tablet, tehrandarou Pharma Corporation) and Placebo (normal saline). During the study period, patients will administer 50 mg Riluzule tablet every 12 hours orally. as the placebo 100 ml of normal saline via slow intravenous infusion will be injected. normal saline will be injected in 4-week cycles. In the first cycle, patients will only inject the placebo within the first 14 days. In the next 11 cycles, patients will only inject the placebo within the first 10 days. Functional evaluation of patient's muscle strength. Timepoint: At the time of enrolling the patient to study, and then every 3 moths in the following period of 1 year. Method of measurement: Manual Muscle Testing (MMT). Functional status of the patient. Timepoint: At the time of enrolling the patient to study, and then every 3 moths in the following period of 1 year. Method of measurement: Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R). Quality of life in the patients. Timepoint: At the time of enrolling the patient to study, and then every 3 moths in the following period of 1 year. Method of measurement: Amyotrophic Lateral Sclerosis Assessment Questionnaire (ALSAQ-40). Esfahan University of Medical Sciences Approved 2017-05-26 Ethical Committee of Isfahan University of Medical Sciences Isfahan University of Medical Sciences, Hezar Jarib Ave., Isfahan, Iran Isfehan Isfehan Iran (Islamic Republic of)