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IRCT20210429051129N1 IRCT 2021-06-07 Qazvin University of Medical Sciences Efficacy of Dalfyra (extended release Fampridine) in fatigue in multiple sclerosis patients Efficacy of Dalfyra (extended release Fampridine) in fatigue in multiple sclerosis patients 2021-06-22 anticipated 88 Complete https://irct.ir/trial/55983 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization method: Patients are divided into two treatment groups A and B using Balance block randomization method, the size of each block is 4 and the total number of blocks is 11. Balanced randomization allocation method for participants in a randomized controlled clinical trial study of the effect of receiving Dalfyra (group A) and placebo (group B) in reducing fatigue in patients with multiple sclerosis Randomization unit: individual Randomization tool: based on statistical software, Blinding description: These patients are divided into two groups based on random allocation: Dalfyra and placebo (11 blocks of 4). Patients in the first group are given famperidine, brand name Dalfyra 10 mg (from cinnagen Pharmaceutical Company) twice a day, and the other group is given a placebo (in the form of tablets by cinnagen Company). This study is double blind and the patient and the executor of the project do not know the type of drug given. 3 Fatigue in patients with multiple sclerosis. Intervention 1: Intervention group: Patients in the intervention group are given Famperidine (Delfyra 10 mg ) (from Cinnagen Pharmaceutical Company) twice daily for three months. Intervention 2: Control group: The control group is given a placebo (in the form of tablets by Cinnagen Pharmaceutical Company) twice a day for three months. Yes - There is a plan to make this available What will be shared: Patient unidentifiable individuals data and the final clinical study report can be Released. When: Releasing after one year of publication of the study results To whom: Academic-scientific institutions Conditions: The use of data and results is permitted for future scientific research. Where to obtain: Receive data by email to the researcher shirin. mavandadi@yahoo.com sh.mavandadi@qums.ac.ir How to obtain: About a month after sending the request Comments:
public Shirin Mavandadi
Bouali Hospital, bouali ave, qazvin
Qazvin Iran (Islamic Republic of) 3413786165 +98 28 3332 6033 sh.mavandadi@qums.ac.ir Qazvin University of Medical Sciences scientific Shirin Mavandadi
Bouali Hospital, bouali ave, qazvin
Qazvin Iran (Islamic Republic of) 3413786165 +98 28 3332 6033 sh.mavandadi@qums.ac.ir Qazvin University of Medical Sciences Iran (Islamic Republic of) Patients with MS over the age of 18 who have not taken Dalfyra for the past year. Patients have The Expanded Disability Status Scale (EDSS) below 7 18 years no limit Both Patients have a kidney problem or a history of seizures. Patients who are allergic to this drug. Patients who have had an acute attack in the last 3 months. G35 Multiple sclerosis Treatment - Drugs Placebo Intervention group: Patients in the intervention group are given Famperidine (Delfyra 10 mg ) (from Cinnagen Pharmaceutical Company) twice daily for three months. Control group: The control group is given a placebo (in the form of tablets by Cinnagen Pharmaceutical Company) twice a day for three months. Fatigue score based on modified fatigue impact scale (MFIS) questionnaire. Timepoint: Both groups complete the Fatigue score based on modified fatigue impact scale (MFIS) questionnaire at the beginning of the study and three months later. Method of measurement: Based on the Fatigue score based on modified fatigue impact scale (MFIS) questionnaire. Qazvin University of Medical Sciences Approved 2021-04-07 Ethics committee of Qazvin University of Medical sciences Qazvin University - Bahonar Blvd- Qazvin Town Qazvin Qazvin Iran (Islamic Republic of)