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IRCT20241129063892N2 IRCT 2024-12-21 Mazandaran University of Medical Sciences The effects of lisdexamphetamine dimesylate on multiple sclerosis patients with fatigue The effects of lisdexamphetamine dimesylate on multiple sclerosis patients with fatigue: A randomized, double blind, placebo-control clinical trial 2024-11-18 anticipated 50 Complete https://irct.ir/trial/80601 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: To randomly assign the samples to two groups of 25, the block method will be used. For this purpose, 13 blocks of four will be considered. The possible blocks are TTCC, TCTC, TCCT, CCTT, CTCT, CTTC, where T is for the intervention group and C is for the control group. Numbers will be generated randomly (with the RANDBETWEEN command in Excel software) and according to the generated values, one of the blocks will be selected and the samples will be allocated. The sampling method will be available sampling, Blinding description: The drug and placebo are placed in identical, specific drug packages from Tekajeh Company, which are coded based on a randomized table. Each code will be assigned to a specific patient. The patients receiving the drug, the assistant evaluating the study variables, and the prescribing neurologist are unaware of the type of drug they are receiving. 3 Fatigue in multiple sclerosis. Intervention 1: Intervention group: For patients, the drug Lysdexamfetamine dimesylate is initially started at a dose of 30 mg daily, and then, if the patient tolerates it, it is increased by 20 mg every 2 weeks to a maximum dose of 70 mg, and then continued for 4 weeks. Intervention 2: Control group: For patients, the placebo drug Lysdexamfetamine dimesylate is initially started at a dose of 30 mg daily, and then, if the patient tolerates it, it is increased by 20 mg every 2 weeks to a maximum dose of 70 mg, and then continued for 4 weeks. Yes - There is a plan to make this available What will be shared: Participants' personal data is shared in its entirety. When: Access begins 6 months after results are published. To whom: Only for researchers working in academic and scientific institutions Conditions: People for the purpose of re-reading or comparing data Where to obtain: By email to the following address: Mohammadbaghbanian@gmail.com How to obtain: The application will be reviewed and responded to within two to four months after the applicant submits their documents. Comments:
public Seyad Mohammad Baghbanian
Boo’Ali hospital, Pasdaran Blvd
Sari Iran (Islamic Republic of) 48158 38477 +98 11 3334 3014 Mohammadbaghbanian@gmail.com Mazandaran University of Medical Sciences scientific Seyad Mohammad Baghbanian
Boo’Ali hospital, Pasdaran Blvd
Sari Iran (Islamic Republic of) 48158 38477 +98 11 3334 3014 Mohammadbaghbanian@gmail.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) Adults with multiple sclerosis according to the McNeeshan 2017 criteria EDSS less than 5.5 MIFS>33 according to the Fatigue criterion. no limit no limit Both Severe depression Hypothyroidism Severe anemia (Hb‹ 9 g/dl) Breastfeeding or pregnancy History of ischemic cerebrovascular accident or cardiovascular disease Decreased kidney function Presence of an MS attack within the past month Uncontrolled blood pressure (blood pressure ≥ 160/100 mm Hg) Concomitant use of medications that affect fatigue History of drug, psychotropic, and alcohol abuse Concomitant use of monoamine oxidase inhibitors and serotonin reuptake inhibitors Presence of narcolepsy The presence of psychosis History of seizures History of vascular disorders G35 Multiple sclerosis Treatment - Drugs Treatment - Drugs Intervention group: For patients, the drug Lysdexamfetamine dimesylate is initially started at a dose of 30 mg daily, and then, if the patient tolerates it, it is increased by 20 mg every 2 weeks to a maximum dose of 70 mg, and then continued for 4 weeks. Control group: For patients, the placebo drug Lysdexamfetamine dimesylate is initially started at a dose of 30 mg daily, and then, if the patient tolerates it, it is increased by 20 mg every 2 weeks to a maximum dose of 70 mg, and then continued for 4 weeks. Fatigue. Timepoint: Beginning of study, weeks 4, 6, 8. Method of measurement: Kurtzke Functional Systems Scores) MSFC,FSS( و PSQI، MFI،SF-36 ، Fatigue Severity Scale (FSS) of Sleep Disorders ، HADS. Mazandaran University of Medical Sciences Approved 2024-11-13 Ethics Committee of Mazandaran University of Medical Sciences Ms clinic, boali hosbital, pasdaran blvd,sari Sari Mazandaran Iran (Islamic Republic of)