Authors
»
[No authors listed]
Category
»
Primary study
Registry of Trials»Iranian Registry of Clinical Trials
Year
»
2021
INTERVENTION: 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. CONDITION: Devic. ; Neuromyelitis optica [Devic] G36.0 PRIMARY OUTCOME: 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. 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. 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. 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. 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. 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. 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. SECONDARY OUTCOME: 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. 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. 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. INCLUSION CRITERIA: 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
Epistemonikos ID: 6acd7961e63908e0f2d5ede562d5183c3b8ede1b
First added on: Mar 31, 2022