Phase 2
N=161
Effect of Natalizumab on Infarct Volume in Acute Ischemic Stroke
Acute Ischemic Stroke
Bottom Line
View on ClinicalTrials.gov: NCT01955707 ↗Enrolled (actual)
161
Serious AEs
46.3%
Results posted
Jul 2016
Primary outcome: Primary: Change in Infarct Volume From Baseline (Diffusion-Weighted Imaging [DWI]) to Day 5 (Fluid-Attenuated Inversion Recovery [FLAIR]) — 2.17; 2.37 mL — p=0.779
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
- Feb 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Infarct Volume From Baseline (Diffusion-Weighted Imaging [DWI]) to Day 5 (Fluid-Attenuated Inversion Recovery [FLAIR]) |
2.17; 2.37 | 0.779 |
| SECONDARY Change in Infarct Volume From Baseline (DWI) to 24 Hours (FLAIR) |
1.73; 1.95 | 0.797 |
| SECONDARY Change in Infarct Volume From Baseline (DWI) to Day 30 (FLAIR) |
1.27; 1.25 | 0.684 |
| SECONDARY Change in Infarct Volume From 24 Hours (FLAIR) to Day 5 (FLAIR) |
1.27; 1.25 | 0.487 |
| SECONDARY Change in Infarct Volume From 24 Hours (FLAIR) to Day 30 (FLAIR) |
0.75; 0.72 | 0.402 |
| SECONDARY Change in Infarct Volume From Day 5 (FLAIR) to Day 30 (FLAIR) |
0.60; 0.59 | 0.394 |
| SECONDARY Change in National Institute of Health Stroke Scale (NIHSS) Score From Baseline to 24 Hours, Day 5, Day 30, and Day 90 |
-1.5; -1.5; -3.3; -2.1; -5.7; -4.9 | 0.427 |
| SECONDARY Modified Rankin Scale (mRS) Distribution at Day 5, Day 30, and Day 90 |
0; 2; 3; 2; 10; 11 | 0.564 |
| SECONDARY Barthel Index at Day 5, Day 30, and Day 90 |
35.0; 30.0; 70.0; 80.0; 80.0; 95.0 | 0.455 |
| SECONDARY Number of Participants Who Experience Adverse Events (AEs) and Serious Adverse Events (SAEs) |
81; 77; 60; 53; 27; 22 | — |
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.
Data sourced from ClinicalTrials.gov (NCT01955707). 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.