Safety and Efficacy of Intravenous Natalizumab in Acute Ischemic Stroke "ACTION2"

Active, not recruiting

Phase 2 Results N/A

Trial Description

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

Conditions

Interventions

  • Placebo Drug
    Intervention Desc: Matched placebo
    ARM 1: Kind: Experimental
    Label: Placebo
    Description: Single dose of Placebo IV at screening
  • Natalizumab Drug
    Other Names: BG00002
    Intervention Desc: Administered as specified in the treatment arm
    ARM 1: Kind: Experimental
    Label: natalizumab high dose
    Description: Single IV (intravenous) dose natalizumab at screening
    ARM 2: Kind: Experimental
    Label: natalizumab low dose
    Description: Single IV dose natalizumab at screening

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Composite global measure of functional disability based on a score of 0 or 1 on the modified Rankin Scale (mRS) Day 5 to Day 90 No
Primary Score of ≥95 on the Barthel Index (BI) Day 5 to Day 90 No
Secondary modified Rankin Scale (mRS) score Day 5 to Day 90 No
Secondary Barthel Index (BI) score Day 5 to Day 90 No
Secondary Stroke Impact Scale-16 (SIS-16) score Day 5 to Day 90 No
Secondary Montreal Cognitive Assessment (MoCA) score Day 5 to Day 90 No
Secondary Number of participants experiencing adverse events (AE) Baseline to Day 90 Yes
Secondary Number of participants experiencing serious adverse events (SAE) Baseline to Day 90 Yes
Secondary National Institute of Health Stroke Scale (NIHSS) score Baseline to Day 90 No

Sponsors