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IRCT20230125057221N1 IRCT 2023-05-04 Tehran University of Medical Sciences Assessment of the effect of lisdexamfetamine on fatigue in patients with multiple sclerosis Assessment of the efficacy of lisdexamfetamine on fatigue in patients with multiple sclerosis: A randomized, double-blind, placebo-controlled study 2023-04-21 anticipated 52 Complete https://irct.ir/trial/68213 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients with MS will be divided into two groups using block randomization method of size 4. The random sequence was created using random allocation software. Concealment is also guaranteed using the block randomization method. The drug and placebo are coded by a person who is not involved in patient admission, patient monitoring and data analysis in the study and are provided to the researcher in the same packaging. The drug and placebo code will be kept with this person until the end of the study, Blinding description: The study is double-blind, and for this purpose, the participants, the main researcher, and the health and medical personnel who are responsible for the care of the patient do not know the type of medicine the patient received. Before the start of the study, the drug and placebo are coded by a person who is not involved in patient recruitment, patient monitoring, and data analysis, and are given to the researcher in completely identical packaging. The drug and placebo codes will be kept with this person until the end of the study. 3 Multiple sclerosis related fatigue. Intervention 1: Intervention group: 26 patients in this group are treated for 2 months with lisdexamfetamine manufactured by Tadbir Kalaye Jam Company. The starting dose is 30 mg daily for one month. If tolerated in the second month, the dose of the drug is increased to 50 mg daily. Intervention 2: Control group: 26 patients in this group are treated with a placebo completely similar to the original drug manufactured by Tadbir Kalaye Jam Company. The starting dose is 30 mg daily for one month. If tolerated in the second month, the dose of the drug is increased to 50 mg daily. No - There is not a plan to make this available Justification or reason for not sharing IPD is According to the items mentioned in the informed consent form, the information of the patients will not be distributed.
public Rayehe Tavajohi
Sina Hospital, Hassan Abad Sq., Imam Khomeini Ave.
Tehran Iran (Islamic Republic of) 1136746911 009821 63120 rayehetavajohi@yahoo.com Tehran University of Medical Sciences scientific Hooshyar Honarmand
Sina Hospital, Hassan Abad Sq., Imam Khomeini Ave.
Tehran Iran (Islamic Republic of) 1136746911 00982163120 hooshyar1978@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Definitive diagnosis of MS based on 2017 McDonald criteria Age 18 to 45 years Informed and written consent of the patient EDSS≤5.5 Total score obtained from MFIS greater than 33 Not changing the type or dose of DMT in the last three months 18 years 45 years Both Pregnancy or breastfeeding Allergy to the drug or formulation ingredients Severe renal failure (ClCr < 30 ml/min/1.73m2) moderate to severe liver failure (Child Pugh B, C) history of attack or receiving pulse dose of corticosteroid in the last one month or during the study Changing the used medication during the study Abuse of alcohol and drugs such as opium or psychoactive agents simultaneous use or last two weeks use of amantadine, modafinil, methylphenidate, dexamphetamine suffering from any untreated thyroid disorder (TSH outside the normal range) Vitamin D level less than 20 ng/ml A patient with anemia (hemoglobin less than 14 g/dL in men or less than 12 g/dL in women) Patients who suffer from severe fatigue and need symptomatic treatment due to ethical considerations History of cardiovascular or cerebrovascular disease such as IHD, ACS, heart failure, any cerebral ischemia and bleeding, and uncontrolled blood pressure (SBP ≥160 or DBP ≥100) Concurrently suffering from any anxiety disorder, severe depression or psychosis for which they are receiving pharmacotherapy History or simultaneous suffering from epilepsy Taking monoamine oxidase inhibitors in the last 14 days G35 Multiple sclerosis Treatment - Drugs Treatment - Drugs Intervention group: 26 patients in this group are treated for 2 months with lisdexamfetamine manufactured by Tadbir Kalaye Jam Company. The starting dose is 30 mg daily for one month. If tolerated in the second month, the dose of the drug is increased to 50 mg daily. Control group: 26 patients in this group are treated with a placebo completely similar to the original drug manufactured by Tadbir Kalaye Jam Company. The starting dose is 30 mg daily for one month. If tolerated in the second month, the dose of the drug is increased to 50 mg daily. Fatigue score in MFIS questionnaire. Timepoint: beginning of the study, 1 month and 2 month after study arrival. Method of measurement: MFIS questionnaire. Blood pressure. Timepoint: beginning of the study, 1 month and 2 month after study arrival. Method of measurement: blood pressure monitor. Heart rate. Timepoint: beginning of the study, 1 month and 2 month after study arrival. Method of measurement: heart rate monitor. Weight. Timepoint: beginning of the study, 1 month and 2 month after study arrival. Method of measurement: scale. Anxiety score. Timepoint: beginning of the study, 1 month and 2 month after study arrival. Method of measurement: Hamilton Anxiety Rating Scale. Sleep quality score. Timepoint: beginning of the study, 1 month and 2 month after study arrival. Method of measurement: Pittsburgh Sleep Quality Index. Depression score. Timepoint: beginning of the study and 2 month after study arrival. Method of measurement: beck depression inventory 2. Research Center for Rational Use of Drugs Tehran University of Medical Sciences Research Center for Rational Use of Drugs Approved 2023-01-21 Research Ethics Committees of The Institute of Pharmaceutical Sciences-Tehran University of Medical Faculty of pharmacy, Tehran University of Medical Sciences, 16 Azar Ave., Enghelab Sq. Tehran Tehran Iran (Islamic Republic of)