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IRCT20190804044429N2 IRCT 2020-06-12 Mazandaran University of Medical Sciences Amantadine and dalfampiridine effects on multiple sclerosis Comparison of amantadine and dalfampridine efficacy in multiple sclerosis patients with fatigue 2020-06-09 anticipated 80 Complete https://irct.ir/trial/48735 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: A master randomization schedule was prepared by a person not associated with the study who used permuted blocks of random numbers. The medicine bottles and identical placebo were prepared by a pharmaceutical manufacturer Randomization was incorporated in the serially numbered bottles containing drug or placebo by person not involved with the study according to random numbers. The number of the bottle corresponded with the number of the patient, Blinding description: participants and principle investigator and statistic staff will be blinded. 2-3 Multiple sclerosis. Intervention 1: Intervention group: dalfampridine 10 m q12 hour for 8 weeks. Intervention 2: Control group: Amantadine 100 mg q 12 hour for 8 weeks. Yes - There is a plan to make this available What will be shared: The results of trial including analysis data and method of the study When: At the time of publication, the data of the study will be available. To whom: academic researchers, medical team and scientific institutes Conditions: For research and practical purposes Where to obtain: Dr. Monireh Ghazaeian, Faculty of pharmacy, Mazandaran University of Medical Sciences. How to obtain: The scientific responsible person of the study will reply to the request within 10 days. Comments:
public Monireh Ghazaeian
Ibn Sina hospital, Pasdaran Blvd, Sari, Mazandaran province, Iran.
Sari Iran (Islamic Republic of) 4815733971 +98 11 3334 3011 ghazaeianm@gmail.com Mazandaran University of Medical Sciences scientific Monireh Ghazaeian
Ibn Sina hospital, Pasdaran Blvd
Sari Iran (Islamic Republic of) 4815733971 +98 11 3334 3011 ghazaeianm@gmail.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) Adult patients were aged more than 18 years Patients with multiple sclerosis according to Mcdonald criteria 2017 and EDSS less than 5.5 MS patients with at least fatigue score of 33 according to MFIS 18 years no limit Both Severe depression Hypothyroidism Severe anemia ( Hb‹ 9 g/dl) Pregnancy or breast feeding Ischemic heart disease or cardiovascular disease Renal insufficiency MS exacerbation within 30 days before Uncontrolled blood pressure (BP more than 160/100 mm Hg) use of other effective treatment on fatigue Alcohol, recreational and substance abuse history Monoamine oxidase inhibitors (MAOIs) use Narcolepsy history Psychosis history Seizure history G35 Multiple sclerosis Treatment - Drugs Treatment - Drugs Intervention group: dalfampridine 10 m q12 hour for 8 weeks Control group: Amantadine 100 mg q 12 hour for 8 weeks Fatigue improvement. Timepoint: At weeks 4, and 8. Method of measurement: MFIS questionnaire. Quality of life. Timepoint: At weeks 4 , 8. Method of measurement: SF-36 Questionnaire. Tolerable of therapeutic regimen. Timepoint: Weekly. Method of measurement: History taking. Mazandaran University of Medical Sciences Approved 2020-05-27 Mazandaran University of Medical Science Ibn Sina Hospital, Pasdaran Blvd, Sari, Mazandaran. Sari Mazandaran Iran (Islamic Republic of)