Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Biogen
Age
18–80
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Clinical diagnosis of supratentorial acute ischemic stroke defined by LKN ≤24 hours prior to study treatment initiation.
Score of 5 to 23 points, inclusive, on the NIHSS at Screening for subjects initiating treatment ≤9 hours from LKN. Note: NIHSS eligibility must be confirmed within 60 minutes prior to randomization.
Score of 5 to 15 points, inclusive, on the NIHSS at Screening for subjects initiating treatment \>9 to ≤24 hours from LKN. Note: NIHSS eligibility must be confirmed within 60 minutes prior to randomization.
Prior to index stroke, patient was able to perform basic activities of daily living without assistance: dressing, eating, walking, bathing, and using the toilet.
For those subjects who underwent a cranial MRI, there is at least 1 acute infarct with a diameter of ≥2 cm on baseline brain diffusion-weighted imaging.
You may not be if
Lacunar or isolated brainstem or cerebellar stroke based on clinical assessment and available acute imaging studies performed under the standard of care.
Presence of acute intracranial hemorrhage on acute brain CT or MRI. However, petechial hemorrhages of ≤1 cm are not exclusionary.
Severe stroke defined by imaging criteria based on either one of the following:
Alberta Stroke Program Early CT (ASPECT) score of 0 to 4 based on head CT or
Acute infarct volume on MRI diffusion weighed imaging greater than or equal to 70 mL
Seizure at the onset of stroke.
Known history of prior treatment with natalizumab.
Known history of active viral hepatitis B or C.
Signs and symptoms of active or acute infection.
Clareo Health | Safety and Efficacy of Intravenous Natalizumab in Acute Ischemic Stroke