Phase 2
N=277
Safety and Efficacy of Intravenous Natalizumab in Acute Ischemic Stroke
Acute Ischemic Stroke
Bottom Line
View on ClinicalTrials.gov: NCT02730455 ↗Enrolled (actual)
277
Serious AEs
26.3%
Results posted
Jan 2019
Primary outcome: Primary: Percentage of Participants With Composite Global Measure of Functional Disability Excellent Outcome at Day 90 — 54.1; 41.5; 39.9 percentage of participants — p=0.086
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- natalizumab (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Biogen
- Primary completion
- Nov 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Composite Global Measure of Functional Disability Excellent Outcome at Day 90 |
54.1; 41.5; 39.9 | 0.086 |
| SECONDARY Percentage of Participants With Excellent Outcome in mRS Score at Day 90 |
41; 29; 26 | 0.222 |
| SECONDARY Percentage of Participants With Excellent Outcome in BI Score at Day 90 |
67; 54; 54 | 0.085 |
| SECONDARY Stroke Impact Scale-16 (SIS-16) Score Using a Repeated Measures Mixed Effects Model at Day 90 |
76.21; 66.96; 68.10 | 0.106 |
| SECONDARY Montreal Cognitive Assessment (MoCA) Score at Day 90 |
21.23; 20.73; 20.90 | 0.780 |
| SECONDARY Change From Baseline in National Institute of Health Stroke Scale (NIHSS) Score at Day 90 |
-6.14; -5.17; -6.28 | 0.315 |
| SECONDARY Number of Participants Experiencing Adverse Events (AE) |
84; 81; 82 | — |
| SECONDARY Number of Participants Experiencing Serious Adverse Events (SAE) |
19; 23; 29 | — |
| SECONDARY Percentage of Participants With Dose Response at Day 90 |
41; 29; 26; 67; 54; 54 | 0.028 sig |
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.
Data sourced from ClinicalTrials.gov (NCT02730455). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.