]>
IRCT20210917052506N1 IRCT 2021-10-10 Esfahan University of Medical Sciences Therapeutic effect of dalfampridine on patients with Devic syndrome Evaluation of the therapeutic efficacy and safety of dalfampridine on patients with Devic syndrome: A triple-blind randomized clinical trial study 2021-10-23 anticipated 70 Complete https://irct.ir/trial/58987 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: After entering the study, patients were individually divided into two groups by simple random sampling using a table of random numbers. Then one of the two groups was randomly assigned to the intervention group by tossing coin, and the other group was named the control group, Blinding description: After completing the informed consent form and knowing how to work, patients are randomly assigned to the intervention and placebo groups without knowing the classified group. Visiting physicians also do not know which group the patient is in. Finally, the data analyzer analyzes the data according to the data collected by the researcher without knowing the data group. 2 Devic. Intervention 1: Intervention group: Patients in this group will receive dalfampridine (chemical compound 4-aminopyridine, FDA approved in MS patients, Nano Hayat Daru Co.) at a concentration of 10 mg twice daily. Then the patients' clinical symptoms and drug response will be evaluated in three visits at times of zero, seven and fourteen weeks. Intervention 2: Control group: Recieving placebo. Yes - There is a plan to make this available What will be shared: All data related to the participants will be accessible after being unidentified When: Access period starts six months after the results are published To whom: Doctors, Researchers Conditions: The data will be available to improve patients' treatment or further research Where to obtain: Dr Shirin Pourajam How to obtain: Sending an email by the applicant including the details of the person and the reason for the request, review of the email by the executor of the project, if the request is confirmed, the data will be sent Comments:
public Shirin Pourajam
No. 2, First door on the left, 27th Dead end, Sheikhbahai Street
Isfahan Iran (Islamic Republic of) 8135816868 +98 31 3233 1062 shirinpourajam@gmail.com Esfahan University of Medical Sciences scientific Shirin Pourajam
No. 2, First door on the left, 27th Dead end, Sheikhbahai Street
Isfahan Iran (Islamic Republic of) 8135816868 +98 31 3233 1062 shirinpourajam@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Age between 16 to 65 years T25FW-based gait disorder: Test between 5 and 60 seconds Definitive diagnosis of Devic disease based on wingerchuc criteria No other neurological or psychological disease No relapse during the three months prior to enrollment 18 years 65 years Both G36.0 Neuromyelitis optica [Devic] Treatment - Drugs Treatment - Drugs Intervention group: Patients in this group will receive dalfampridine (chemical compound 4-aminopyridine, FDA approved in MS patients, Nano Hayat Daru Co.) at a concentration of 10 mg twice daily. Then the patients' clinical symptoms and drug response will be evaluated in three visits at times of zero, seven and fourteen weeks. Control group: Recieving placebo Timed 25-foot Walk score. Timepoint: The first visit at the beginning of the study, the second visit in the seventh week, the third visit in the fourteenth week. Method of measurement: Examination by T25W table. Lower extremity manual muscle test Score. Timepoint: The first visit at the beginning of the study, the second visit in the seventh week, the third visit in the fourteenth week. Method of measurement: Examination by LEMMT table. 12-item Multiple Sclerosis Walking Scale Score. Timepoint: The first visit at the beginning of the study, the second visit in the seventh week, the third visit in the fourteenth week. Method of measurement: Examination by MSWS-12 table. Quality of life score. Timepoint: The first visit at the beginning of the study, the second visit in the seventh week, the third visit in the fourteenth week. Method of measurement: Questionnaire SF-36. Depression score. Timepoint: The first visit at the beginning of the study, the second visit in the seventh week, the third visit in the fourteenth week. Method of measurement: Questionnaire BDI. Anxiety score. Timepoint: The first visit at the beginning of the study, the second visit in the seventh week, the third visit in the fourteenth week. Method of measurement: Questionnaire BAI. Disability Status Scale (EDSS). Timepoint: The first visit at the beginning of the study, the second visit in the seventh week, the third visit in the fourteenth week. Method of measurement: Examination, EDSS table. Quality of life score. Timepoint: The first visit at the beginning of the study, the second visit in the seventh week, the third visit in the fourteenth week. Method of measurement: Questionnaire SF-36. Depression score. Timepoint: The first visit at the beginning of the study, the second visit in the seventh week, the third visit in the fourteenth week. Method of measurement: BDI Questionnaire. Anxiety score. Timepoint: The first visit at the beginning of the study, the second visit in the seventh week, the third visit in the fourteenth week. Method of measurement: BAI Questionnaire. Esfahan University of Medical Sciences Approved 2021-08-01 Ethics committee of Isfahan University of Medical Sciences Hezarjarib st , Isfahan University of Medical Science Isfahan Isfehan Iran (Islamic Republic of)