Effect of Natalizumab on Infarct Volume in Acute Ischemic Stroke
Condition: Acute Ischemic Stroke
MeSH terms: Stroke; Ischemic Stroke; Cerebral Infarction; Ischemia
Intervention: natalizumab; Placebo
Intervention description: Administered as described 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: Double (Participant, Investigator)
Enrollment: 161.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      The primary objective of the study is to determine whether one 300 mg dose of intravenous
      (IV) natalizumab reduces change in infarct volume from Baseline to Day 5 on magnetic
      resonance imaging (MRI) in participants with acute ischemic stroke when given at ≤6 hours or
      at >6 to ≤9 hours from when they were last known normal (LKN).

      The secondary objectives of this study in this study population are as follows: to assess the
      efficacy of natalizumab on change in infarct volume from Baseline to Day 30; to assess
      efficacy of natalizumab on change in infarct volume from 24 hours to Day 5 and Day 30; to
      assess the efficacy of natalizumab on clinical measures of stroke outcome; to assess the
      safety of natalizumab in participants with acute ischemic stroke.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Diagnosis of acute ischemic stroke.

          -  Score of ≥6 points on the National Institute of Health Stroke Scale (NIHSS) at
             Screening.

          -  At least 1 acute infarct with largest diameter of more than 2 cm on Baseline brain
             diffusion-weighted imaging (DWI).

          -  Participants who have received reperfusion therapy may be eligible to participate but
             must meet all eligibility criteria and perform the Baseline study magnetic resonance
             imaging (MRI) after reperfusion therapy has been completed.

          -  Subjects of childbearing potential must practice effective contraception during the
             study and be willing and able to continue contraception for at least 3 months after
             their dose of study treatment.

        Key Exclusion Criteria:

          -  Presence of any intracranial hemorrhage (ICH) on head computed tomography (CT) or
             non-petechial ICH on screening MRI.

          -  Stroke isolated to the brainstem.

          -  Presence of coma

          -  Expected to die OR unable to be evaluated within 5 days.

          -  Hypotension requiring the use of intravenous (IV) vasopressor support or systolic
             blood pressure <90 mmHg at the time of randomization.

          -  Known prior treatment with natalizumab.

          -  Immunocompromised subjects, as determined by the Investigator.

          -  History of progressive multifocal leukoencephalopathy (PML).

          -  Contraindications to MRI, e.g., implanted pacemaker or other contraindicated implanted
             metal devices, history of or risk for side effects from gadolinium, or claustrophobia
             that cannot be medically managed.

        NOTE: Other protocol-defined inclusion/exclusion criteria may apply.