Safety and Efficacy of Intravenous Natalizumab in Acute Ischemic Stroke
Condition: Acute Ischemic Stroke
MeSH terms: Stroke; Ischemic Stroke; Cerebral Infarction; Ischemia
Intervention: natalizumab; Placebo
Intervention description: Administered as specified in the treatment arm; Matched placebo
Intervention MeSH terms: Natalizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 277.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Stroke

Summary:

      The primary objective of the study is to assess the clinical effects of natalizumab versus
      placebo in acute ischemic stroke on clinical measures of functional independence and
      activities of daily living. The secondary objective of the study is to explore dose and
      exposure response and the clinical treatment effects of natalizumab versus placebo in acute
      ischemic stroke on the following: measures of independence, activities of daily living,
      neurologic function, quality of life, cognition, and safety and tolerability
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  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.

        Key Exclusion Criteria:

          -  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.

        NOTE: Other protocol-defined inclusion/exclusion criteria may apply.