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IRCT20180224038841N1 IRCT 2019-01-13 Tehran University of Medical Sciences Evaluation of efficacy of Dimethyl Fumarate in stroke Comparing the effect of Dimethyl fumarate and Placebo on infarct size and NIHSS score in acute ischemic stroke patients 2018-12-31 anticipated 32 Complete https://irct.ir/trial/34326 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: According to the table of random numbers patients are assigned to drug or placebo group, Blinding description: It's a double blind clinical trial. The care provider, the outcome assessor, the patients and the investigator are all blind. The drugs are labeled by "A" and "B" and the process of labeling the drugs (dimethyl fumarate and placebo) with "A" and "B" is done by a clinical pharmacist who is not involved in any other process in the trial. 2 Ischemic Stroke. Intervention 1: Intervention group: Dimethyl fumarate 240mg , three times a day for one week. Intervention 2: Control group: Placebo , three times a day for one week. Yes - There is a plan to make this available What will be shared: only the data related to the main and secondary objectives of the study can be shared. When: Starting access 3 months after publication To whom: only available for people working at academic institutions and universities Conditions: the request must be sent to the corresponding author by email and it will be decided per case. Where to obtain: By sending the request for the corresponding author through an email. How to obtain: The reason of asking for the data along with the request for the data must be sent to the corresponding author via email.After evaluating the reason for asking the data, the data will be provided if possible. Comments:
public Seyed Mehrdad Savar
Neurology ward, first floor, Shariati Hospital, Jalal Al Ahmad three way, North Kargar street
Tehran Iran (Islamic Republic of) 1411713135 +98 21 8822 0040 mehrdad.savar@gmail.com Tehran University of Medical Sciences scientific Seyed Mehrdad Savar
Neurology ward, first floor, Shariati Hospital, Jalal Al Ahmad three way, North Kargar street
Tehran Iran (Islamic Republic of) 1411713135 +98 21 8822 0040 mehrdad.savar@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Patients at the age of 18-85 years old Patients with acute neurological symptoms who have been diagnosed as ischemic stroke by a neurologist 18 years 85 years Both Patients with prior sensitivity to dimethyl fumarate Patients with serious infections Pregnancy and lactation Immunologic deficiencies in the past 6 months (i.e. cancer,lymphoma, HIV and viral hepatitis) Patients receiving rtPA Patients who undergo endovascular treatment Liver function test more than 2 times of normal range Initial WBC count under 3500 lymphopenia under 500 Treatment - Drugs Placebo Intervention group: Dimethyl fumarate 240mg , three times a day for one week Control group: Placebo , three times a day for one week Infarct Size in Magnetic Resonance Imaging(MRI). Timepoint: An MRI at the beginning of the trial and a second one after 15 to 45 days from starting Dimethyl fumarate or Placebo. Method of measurement: using automatic softwares. National Institute of Health Stroke Scale (NIHSS). Timepoint: at the beginning of the trial and 30 days after starting Dimethyl fumarate. Method of measurement: NIHSS checklist. Tehran University of Medical Sciences Approved 2018-02-21 Ethics committee of Tehran University of Medical Sciences Central Headquarters of Tehran University of Medical Sciences, Keshavarz Blvd. and Ghodss St. Intersection Tehran Tehran Iran (Islamic Republic of)