Ischemic stroke. Cerebral infarction, unspecified
Conditions
Interventions
Intervention 1: Intervention group: 0.5 mg of oral Norabex (fingolimod
Dr. Abidi Pharmaceuticals) administered once daily for three consecutive days. Intervention 2: Control group: 0.5 mg of oral placebo (Dr. Abidi Pharmaceuticals) administered once daily for three conse
Sponsors
Tabriz University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Male and female patients aged 18 years or older with acute ischemic stroke Onset of symptoms within 6 to 72 hours Unilateral anterior cerebral circulation occlusion Minimum literacy No movement problems in the dominant hand
Exclusion criteria
Exclusion criteria: Any pre-existing neurological deficit, regardless of cause Bradyarrhythmia Atrioventricular blocks Rapid improvement of clinical symptoms before starting treatment Baseline NIHSS score less than 5 Aphasia and any disorder that prevents the assessment of cognitive ability Concomitant use of anticancer drugs, immunosuppressants/modulators Pregnant and breastfeeding women Macular edema Swallowing difficulties
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The National Institutes of Health Stroke Scale Score. Timepoint: At baseline (prior to the first dose, i.e., at the time of admission), and at 7 and 90 days post-first dose. Method of measurement: The National Institutes of Health Stroke Scale. | — |
Secondary
| Measure | Time frame |
|---|---|
| The Modified Rankin Score. Timepoint: At baseline (prior to the first dose, i.e., at the time of admission), and at 7 and 90 days post-first dose. Method of measurement: The Modified Rankin Score.;The Montreal Cognitive Assessment score. Timepoint: At baseline (prior to the first dose, i.e., at the time of admission), and at 7 and 90 days post-first dose. Method of measurement: The Montreal Cognitive Assessment.;Lymphocyte subset cells count. Timepoint: At baseline (prior to the first dose, i.e., at the time of admission), and at 7 and 90 days post-first dose. Method of measurement: Flow cytometry technique.;The degree of change in lesion volume. Timepoint: At baseline (prior to the first dose, i.e., at the time of admission), and at 7 and 30 days post-first dose. Method of measurement: Magnetic resonance imaging. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMehdi Farhoudi, M.D.
Tabriz University of Medical Sciences
Outcome results
None listed