CClinicalTrials.gg
Sign In
CompletedNCT01955707ACTIONUpdated Jul 1, 2016Results posted

Effect of Natalizumab on Infarct Volume in Acute Ischemic Stroke

A Phase 2 interventional study of natalizumab and Placebo in Acute Ischemic Stroke, sponsored by Biogen. Completed at 50 sites in 3 countries. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2016-07-01.

Sponsored by Biogen · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
161
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Acute Ischemic Stroke
03

In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.

This study's enrollment of 161 is above the median of 50 across 5,369 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Biogen is the lead sponsor of 494 studies on the registry; 22 are open to participants now.

Of its 98 completed or terminated interventional studies of FDA-regulated products, 49 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

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.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
161 participants (actual)

Study arms

  • Experimental
    natalizumab

    300 mg single intravenous (IV) injection

    Drug: natalizumab

  • Placebo comparator
    Placebo

    A single IV dose of placebo

    Drug: Placebo

Interventions

  • Drugnatalizumab

    Administered as described in the treatment arm

    Also known as: Tysabri, BG00002

  • DrugPlacebo

    Matched placebo

06

What researchers measure

Primary outcomes

  1. Change in Infarct Volume From Baseline (Diffusion-Weighted Imaging [DWI]) to Day 5 (Fluid-Attenuated Inversion Recovery [FLAIR])

    Relative growth of infarct volume from Baseline (relative growth = FLAIR at Day 5 divided by Baseline DWI). Geometric mean calculated as the exponential of the mean log relative growth.

    Time frame: Baseline, Day 5

Secondary outcomes

  1. Change in Infarct Volume From Baseline (DWI) to 24 Hours (FLAIR)

    Relative growth of infarct volume from Baseline (relative growth = FLAIR at 24 hours divided by Baseline DWI). Geometric mean calculated as the exponential of the mean log relative growth.

    Time frame: Baseline, 24 hrs

  2. Change in Infarct Volume From Baseline (DWI) to Day 30 (FLAIR)

    Relative growth of infarct volume from Baseline (relative growth = FLAIR at Day 30 divided by Baseline DWI). Geometric mean calculated as the exponential of the mean log relative growth.

    Time frame: Baseline, Day 30

  3. Change in Infarct Volume From 24 Hours (FLAIR) to Day 5 (FLAIR)

    Relative growth of infarct volume from 24 hours (relative growth = FLAIR at Day 5 divided by FLAIR at 24 hours). Geometric mean calculated as the exponential of the mean log relative growth.

    Time frame: 24 hours, Day 5

  4. Change in Infarct Volume From 24 Hours (FLAIR) to Day 30 (FLAIR)

    Relative growth in infarct volume from Baseline (relative growth = FLAIR Day 30 divided by FLAIR at 24 hours ). Geometric mean calculated as the exponential of the mean log relative growth.

    Time frame: 24 hours, Day 30

  5. Change in Infarct Volume From Day 5 (FLAIR) to Day 30 (FLAIR)

    Relative growth of infarct volume from Day 5 (relative growth = FLAIR at Day 30 divided by FLAIR at Day 5). Geometric mean calculated as the exponential of the mean log relative growth.

    Time frame: Day 5, Day 30

  6. Change in National Institute of Health Stroke Scale (NIHSS) Score From Baseline to 24 Hours, Day 5, Day 30, and Day 90

    The NIHSS is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Scores for the NIHSS range from 0 to 42, with 0 representing no symptoms and 42 representing death.

    Time frame: Baseline, 24 hours, Day 5, Day 30, Day 90

  7. Modified Rankin Scale (mRS) Distribution at Day 5, Day 30, and Day 90

    The mRS measures independence, rather than neurologic function, with specific tasks pre- and post-stroke, respectively. The scale consists of 7 grades, from 0 to 6, with 0 corresponding to no symptoms and 6 corresponding to death. The distribution of mRS scores was summarized at each timepoint. An excellent outcome on the mRS was defined as a score of 0 or 1, while a good outcome was defined as a score of 0, 1, or 2.

    Time frame: Day 5, Day 30, and Day 90

  8. Barthel Index at Day 5, Day 30, and Day 90

    The Barthel Index consists of 10 items that measure a person's daily functioning, specifically the activities of daily living and mobility, and can be used to determine a baseline level of functioning and to monitor change in activities of daily living over time. The scores for each of the items are summed to create a total score up to a potential of 100, with higher scores representing a greater level of independence.

    Time frame: Day 5, Day 30, and Day 90

  9. Number of Participants Who Experience Adverse Events (AEs) and Serious Adverse Events (SAEs)

    AE: any untoward medical occurrence that does not necessarily have a causal relationship with this treatment. SAE: any untoward medical occurrence that at any dose: results in death; in the view of the Investigator, places the participant at immediate risk of death (a life-threatening event); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in a congenital anomaly/birth defect; any other medically important event that, in the opinion of the Investigator, may jeopardize the participant or may require intervention to prevent one of the other outcomes listed in the definition above. Events were categorized as severe, moderate, or mild, and related or not related to study treatment.

    Time frame: Up to Day 90 ± 5 days

07

Results

Posted Jul 1, 2016

Participant flow

Participant flow — Overall Study
MilestonePlaceboNatalizumab
Started8279
Withdrew prior to dosing01
Dosed8278
Received total volume of study drug8277
Completed6257
Not completed2022
Withdrew: Adverse event12
Withdrew: Lost to follow-up21
Withdrew: Withdrawal by subject03
Withdrew: Death1314
Withdrew: Other42

Outcome measures

PrimaryChange in Infarct Volume From Baseline (Diffusion-Weighted Imaging [DWI]) to Day 5 (Fluid-Attenuated Inversion Recovery [FLAIR])

Relative growth of infarct volume from Baseline (relative growth = FLAIR at Day 5 divided by Baseline DWI). Geometric mean calculated as the exponential of the mean log relative growth.

Time frame:
Baseline, Day 5
Reported as:
Geometric mean · mL
Change in Infarct Volume From Baseline (Diffusion-Weighted Imaging [DWI]) to Day 5 (Fluid-Attenuated Inversion Recovery [FLAIR])
mLPlaceboNatalizumab
Change in Infarct Volume From Baseline (Diffusion-Weighted Imaging [DWI]) to Day 5 (Fluid-Attenuated Inversion Recovery [FLAIR])2.17 (1.60 to 3.17)2.37 (1.51 to 2.91)
Statistical analysis
  • Placebo vs Natalizumab · Adjusted mean difference (log-scale): 0.08 · 90% CI -0.09 to 0.26
  • Placebo vs Natalizumab · repeated measures mixed effects model · p = 0.779 (one-sided p-value) · Ratio of relative growth: 1.09 · 90% CI 0.91 to 1.30Adjusted mean (log-scale) back-transformed to the original scale as the estimated ratio of natalizumab to placebo. 90% confidence interval (log-scale) back-transformed to the original scale and reflect the interval around the ratio.
SecondaryChange in Infarct Volume From Baseline (DWI) to 24 Hours (FLAIR)

Relative growth of infarct volume from Baseline (relative growth = FLAIR at 24 hours divided by Baseline DWI). Geometric mean calculated as the exponential of the mean log relative growth.

Time frame:
Baseline, 24 hrs
Reported as:
Geometric mean · mL
Change in Infarct Volume From Baseline (DWI) to 24 Hours (FLAIR)
mLPlaceboNatalizumab
Change in Infarct Volume From Baseline (DWI) to 24 Hours (FLAIR)1.73 (1.33 to 2.15)1.95 (1.36 to 2.20)
Statistical analysis
  • Placebo vs Natalizumab · Adjusted mean difference (log-scale): 0.09 · 90% CI -0.09 to 0.27
  • Placebo vs Natalizumab · repeated measures mixed effects model · p = 0.797 (one-sided p-value) · Ratio of relative growth: 1.09 · 90% CI 0.92 to 1.31Adjusted mean (log-scale) back-transformed to the original scale as the estimated ratio of natalizumab to placebo. 90% confidence interval (log-scale) back-transformed to the original scale and reflect the interval around the ratio.
SecondaryChange in Infarct Volume From Baseline (DWI) to Day 30 (FLAIR)

Relative growth of infarct volume from Baseline (relative growth = FLAIR at Day 30 divided by Baseline DWI). Geometric mean calculated as the exponential of the mean log relative growth.

Time frame:
Baseline, Day 30
Reported as:
Geometric mean · mL
Change in Infarct Volume From Baseline (DWI) to Day 30 (FLAIR)
mLPlaceboNatalizumab
Change in Infarct Volume From Baseline (DWI) to Day 30 (FLAIR)1.27 (0.90 to 1.88)1.25 (0.78 to 1.93)
Statistical analysis
  • Placebo vs Natalizumab · Adjusted mean difference (log-scale): 0.05 · 90% CI -0.13 to 0.24
  • Placebo vs Natalizumab · repeated measures mixed effects model · p = 0.684 (one-sided p-value) · Ratio of relative growth: 1.05 · 90% CI 0.88 to 1.27Adjusted mean (log-scale) back-transformed to the original scale as the estimated ratio of natalizumab to placebo. 90% confidence interval (log-scale) back-transformed to the original scale and reflect the interval around the ratio.
SecondaryChange in Infarct Volume From 24 Hours (FLAIR) to Day 5 (FLAIR)

Relative growth of infarct volume from 24 hours (relative growth = FLAIR at Day 5 divided by FLAIR at 24 hours). Geometric mean calculated as the exponential of the mean log relative growth.

Time frame:
24 hours, Day 5
Reported as:
Geometric mean · mL
Change in Infarct Volume From 24 Hours (FLAIR) to Day 5 (FLAIR)
mLPlaceboNatalizumab
Change in Infarct Volume From 24 Hours (FLAIR) to Day 5 (FLAIR)1.27 (1.11 to 1.37)1.25 (1.11 to 1.42)
Statistical analysis
  • Placebo vs Natalizumab · Adjusted mean difference (log-scale): -0.00 · 90% CI -0.12 to 0.11
  • Placebo vs Natalizumab · repeated measures mixed effects model · p = 0.487 (one-sided p-value) · Ratio of relative growth: 1.00 · 90% CI 0.89 to 1.12Adjusted mean (log-scale) back-transformed to the original scale as the estimated ratio of natalizumab to placebo. 90% confidence interval (log-scale) back-transformed to the original scale and reflect the interval around the ratio.
SecondaryChange in Infarct Volume From 24 Hours (FLAIR) to Day 30 (FLAIR)

Relative growth in infarct volume from Baseline (relative growth = FLAIR Day 30 divided by FLAIR at 24 hours ). Geometric mean calculated as the exponential of the mean log relative growth.

Time frame:
24 hours, Day 30
Reported as:
Geometric mean · mL
Change in Infarct Volume From 24 Hours (FLAIR) to Day 30 (FLAIR)
mLPlaceboNatalizumab
Change in Infarct Volume From 24 Hours (FLAIR) to Day 30 (FLAIR)0.75 (0.62 to 1.03)0.72 (0.56 to 1.09)
Statistical analysis
  • Placebo vs Natalizumab · Adjusted mean difference (log-scale): -0.02 · 90% CI -0.14 to 0.10
  • Placebo vs Natalizumab · repeated measures mixed effects model · p = 0.402 (one-sided p-value) · Ratio of relative growth: 0.98 · 90% CI 0.87 to 1.11Adjusted mean (log-scale) back-transformed to the original scale as the estimated ratio of natalizumab to placebo. 90% confidence interval (log-scale) back-transformed to the original scale and reflect the interval around the ratio.
SecondaryChange in Infarct Volume From Day 5 (FLAIR) to Day 30 (FLAIR)

Relative growth of infarct volume from Day 5 (relative growth = FLAIR at Day 30 divided by FLAIR at Day 5). Geometric mean calculated as the exponential of the mean log relative growth.

Time frame:
Day 5, Day 30
Reported as:
Geometric mean · mL
Change in Infarct Volume From Day 5 (FLAIR) to Day 30 (FLAIR)
mLPlaceboNatalizumab
Change in Infarct Volume From Day 5 (FLAIR) to Day 30 (FLAIR)0.60 (0.52 to 0.79)0.59 (0.42 to 0.81)
Statistical analysis
  • Placebo vs Natalizumab · Adjusted mean difference (log-scale): -0.02 · 90% CI -0.18 to 0.13
  • Placebo vs Natalizumab · repeated measures mixed effects model · p = 0.394 (one-sided p-value) · Ratio of relative growth: 0.98 · 90% CI 0.84 to 1.14Adjusted mean (log-scale) back-transformed to the original scale as the estimated ratio of natalizumab to placebo. 90% confidence interval (log-scale) back-transformed to the original scale and reflect the interval around the ratio.
SecondaryChange in National Institute of Health Stroke Scale (NIHSS) Score From Baseline to 24 Hours, Day 5, Day 30, and Day 90

The NIHSS is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Scores for the NIHSS range from 0 to 42, with 0 representing no symptoms and 42 representing death.

Time frame:
Baseline, 24 hours, Day 5, Day 30, Day 90
Reported as:
Mean · units on a scale
Change in National Institute of Health Stroke Scale (NIHSS) Score From Baseline to 24 Hours, Day 5, Day 30, and Day 90
units on a scalePlaceboNatalizumab
Change at 24 hours; n=82, 77-1.5 ± 3.96-1.5 ± 5.10
Change at Day 5; n=79, 72-3.3 ± 5.31-2.1 ± 6.24
Change at Day 30; n=73, 62-5.7 ± 5.22-4.9 ± 5.73
Change at Day 90; n=62, 56-7.3 ± 3.95-6.8 ± 5.78
Statistical analysis
  • Placebo vs Natalizumab · repeated measures mixed effects model · p = 0.427 (one-sided p-value) · Adjusted mean change from baseline: -0.25 · 90% CI -2.48 to 1.98
  • Placebo vs Natalizumab · repeated measures mixed effects model · p = 0.896 (one-sided p-value) · Adjusted mean change from baseline: 1.71 · 90% CI -0.52 to 3.94
  • Placebo vs Natalizumab · repeated measures mixed effects model · p = 0.989 (one-sided p-value) · Adjusted mean change from baseline: 3.15 · 90% CI 0.89 to 5.40
  • Placebo vs Natalizumab · repeated measures mixed effects model · p = 0.915 (one-sided p-value) · Adjusted mean change from baseline: 1.93 · 90% CI -0.38 to 4.25
SecondaryModified Rankin Scale (mRS) Distribution at Day 5, Day 30, and Day 90

The mRS measures independence, rather than neurologic function, with specific tasks pre- and post-stroke, respectively. The scale consists of 7 grades, from 0 to 6, with 0 corresponding to no symptoms and 6 corresponding to death. The distribution of mRS scores was summarized at each timepoint. An excellent outcome on the mRS was defined as a score of 0 or 1, while a good outcome was defined as a score of 0, 1, or 2.

Time frame:
Day 5, Day 30, and Day 90
Reported as:
Number · participants
Modified Rankin Scale (mRS) Distribution at Day 5, Day 30, and Day 90
participantsPlaceboNatalizumab
Day 5: Score 0; n=82, 7602
Day 5: Score 1; n=82, 7632
Day 5: Score 2; n=82, 761011
Day 5: Score 3; n=82, 761311
Day 5: Score 4; n=82, 762516
Day 5: Score 5; n=82, 762931
Day 5: Score 6; n=82, 7623
Day 30: Score 0; n=81, 7205
Day 30: Score 1; n=81, 7278
Day 30: Score 2; n=81, 72148
Day 30: Score 3; n=81, 721717
Day 30: Score 4; n=81, 722214
Day 30: Score 5; n=81, 721311
Day 30: Score 6; n=81, 7289
Day 90: Score 0; n=78, 7248
Day 90: Score 1; n=78, 721210
Day 90: Score 2; n=78, 721210
Day 90: Score 3; n=78, 721513
Day 90: Score 4; n=78, 721411
Day 90: Score 5; n=78, 7286
Day 90: Score 6; n=78, 721314
Statistical analysis
  • Placebo vs Natalizumab · Van Elteren's test · p = 0.564 (One sided p-value based on Van Elteren's test, adjusting for baseline DWI volume (\< median vs \>= median), treatment time window, location of stroke abnormality (cortical/subcortical), and tPA use (yes/no).) · Odds ratio (or): 0.89 · 90% CI 0.55 to 1.45
  • Placebo vs Natalizumab · Van Elteren's test · p = 0.077 (One-sided p-value based on Van Elteren's test, adjusting for baseline DWI volume (\< median vs \>= median), treatment time window, location of stroke abnormality (cortical/subcortical), and tPA use (yes/no).) · Odds ratio (or): 1.30 · 90% CI 0.80 to 2.10
  • Placebo vs Natalizumab · Van Elteren's test · p = 0.243 (One -sided p-value based on Van Elteren's test, adjusting for baseline DWI volume (\< median vs \>= median), treatment time window, location of stroke abnormality (cortical/subcortical), and tPA use (yes/no).) · Odds ratio (or): 1.15 · 90% CI 0.71 to 1.86
SecondaryBarthel Index at Day 5, Day 30, and Day 90

The Barthel Index consists of 10 items that measure a person's daily functioning, specifically the activities of daily living and mobility, and can be used to determine a baseline level of functioning and to monitor change in activities of daily living over time. The scores for each of the items are summed to create a total score up to a potential of 100, with higher scores representing a greater level of independence.

Time frame:
Day 5, Day 30, and Day 90
Reported as:
Median · units on a scale
Barthel Index at Day 5, Day 30, and Day 90
units on a scalePlaceboNatalizumab
Day 5; n=78, 7335.0 (0 to 100)30.0 (0 to 100)
Day 30; n=73, 6070.0 (0 to 100)80.0 (0 to 100)
Day 90; n=61, 5580.0 (0 to 100)95.0 (0 to 100)
Statistical analysis
  • Placebo vs Natalizumab · repeated measures mixed effects model · p = 0.455 (one-sided p-value) · Adjusted mean: 0.68 · 90% CI -9.19 to 10.56
  • Placebo vs Natalizumab · repeated measures mixed effects model · p = 0.420 (one-sided p-value) · Adjusted mean: 1.21 · 90% CI -8.76 to 11.19
  • Placebo vs Natalizumab · repeated measures mixed effects model · p = 0.283 · Adjusted mean: 3.56 · 90% CI -6.64 to 13.75
SecondaryNumber of Participants Who Experience Adverse Events (AEs) and Serious Adverse Events (SAEs)

AE: any untoward medical occurrence that does not necessarily have a causal relationship with this treatment. SAE: any untoward medical occurrence that at any dose: results in death; in the view of the Investigator, places the participant at immediate risk of death (a life-threatening event); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in a congenital anomaly/birth defect; any other medically important event that, in the opinion of the Investigator, may jeopardize the participant or may require intervention to prevent one of the other outcomes listed in the definition above. Events were categorized as severe, moderate, or mild, and related or not related to study treatment.

Time frame:
Up to Day 90 ± 5 days
Reported as:
Number · participants
Number of Participants Who Experience Adverse Events (AEs) and Serious Adverse Events (SAEs)
participantsPlaceboNatalizumab
Participants with an event8177
Participants with a moderate or severe event6053
Participants with a severe event2722
Participants with a related event76
Participants with a serious event3836
Participants discontinuing due to an event00
Participants withdrawing from study due to event21

Adverse events

Collected over From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo—38/82 (46.3%)75/82 (91.5%)
Natalizumab—36/78 (46.2%)68/78 (87.2%)
Most frequent serious events
Showing 10 of 68
Most frequent serious events
EventPlaceboNatalizumab
Cerebral infarctionNervous system disorders2/824/78
Haemorrhagic transformation strokeNervous system disorders3/824/78
PneumoniaInfections and infestations2/823/78
Carotid artery stenosisNervous system disorders1/823/78
Multi-organ failureGeneral disorders0/822/78
Cerebrovascular accidentNervous system disorders2/822/78
ConvulsionNervous system disorders0/822/78
Stroke in evolutionNervous system disorders0/822/78
Respiratory failureRespiratory, thoracic and mediastinal disorders0/822/78
Cardiac failureCardiac disorders2/820/78
Most frequent other events
Showing 10 of 38
Most frequent other events
EventPlaceboNatalizumab
PyrexiaGeneral disorders26/8232/78
ConstipationGastrointestinal disorders23/8224/78
Haemorrhagic transformation strokeNervous system disorders21/8218/78
Urinary tract infectionInfections and infestations13/8219/78
HeadacheNervous system disorders19/8213/78
HypertensionVascular disorders10/8215/78
VomitingGastrointestinal disorders15/825/78
DepressionPsychiatric disorders13/825/78
InsomniaPsychiatric disorders13/827/78
HypotensionVascular disorders12/822/78

Baseline characteristics

Age, Continuous
Age, Continuous(years)PlaceboNatalizumabTotal
Mean71.6 ± 11.8370.3 ± 13.3471.0 ± 12.57
Age, Customized
Age, Customized(participants)PlaceboNatalizumabTotal
</= 39 years235
40 to 59 years131124
60 to 79 years414586
>/= 80 years262046
Sex: Female, Male
Sex: Female, Male(Participants)PlaceboNatalizumabTotal
Female343872
Male484189
08

Study locations

50 sites
  • Research Site
    San Diego, California, United States
  • Research Site
    Gainesville, Florida, United States
  • Research Site
    Kansas City, Kansas 66160, United States
  • Research Site
    Boston, Massachusetts 02114, United States
  • Research Site
    Golden Valley, Minnesota 55422, United States
  • Research Site
    St. Louis, Missouri 63110, United States
  • Research Site
    Lake Success, New York, United States
  • Research Site
    New York, New York 10032, United States
  • Research Site
    Durham, North Carolina 27710, United States
  • Research Site
    Akron, Ohio, United States
  • Research Site
    Dayton, Ohio 45409, United States
  • Research Site
    Toledo, Ohio, United States
  • Research Site
    Portland, Oregon, United States
  • Research Site
    Tualatin, Oregon 97062, United States
  • Research Site
    Philadelphia, Pennsylvania 19104, United States
  • Research Site
    Nashville, Tennessee, United States
  • Research Site
    Dallas, Texas, United States
  • Research Site
    Charlottesville, Virginia, United States
  • Research Site
    Milwaukee, Wisconsin, United States
  • Research Site
    Altenburg, 04600, Germany
  • Research Site
    Bad Neustadt, 97616, Germany
  • Research Site
    Berlin, 12203, Germany
  • Research Site
    Bonn, Germany
  • Research Site
    Duesseldorf, 40225, Germany
  • Research Site
    Erlangen, 91054, Germany
  • Research Site
    Frankfurt, 60528, Germany
  • Research Site
    Hannover, Germany
  • Research Site
    Heidelberg, 69120, Germany
  • Research Site
    Idar-Oberstein, 55743, Germany
  • Research Site
    Leipzig, 04103, Germany
  • Research Site
    Ludwigshafen, 67063, Germany
  • Research Site
    Ludwigshafen, Germany
  • Research Site
    Mannheim, Germany
  • Research Site
    Trier, 54290, Germany
  • Research Site
    Tübingen, 72076, Germany
  • Research Site
    Ulm, Germany
  • Research Site
    Albacete, 02006, Spain
  • Research Site
    Badalona, 8916, Spain
  • Research Site
    Barakaldo, Spain
  • Research Site
    Barcelona, 8003, Spain
  • Research Site
    Barcelona, 8035, Spain
  • Research Site
    Barcelona, 8036, Spain
  • Research Site
    Girona, 17007, Spain
  • Research Site
    Madrid, 28034, Spain
  • Research Site
    Pamplona, 31008, Spain
  • Research Site
    Santiago de Compostela, 15706, Spain
  • Research Site
    Sevilla, 41009, Spain
  • Research Site
    Sevilla, 41013, Spain
  • Research Site
    Valencia, Spain
  • Research Site
    Valladolid, 47005, Spain
09

References and documents

Publications

  • Elkins J, Veltkamp R, Montaner J, Johnston SC, Singhal AB, Becker K, Lansberg MG, Tang W, Chang I, Muralidharan K, Gheuens S, Mehta L, Elkind MSV. Safety and efficacy of natalizumab in patients with acute ischaemic stroke (ACTION): a randomised, placebo-controlled, double-blind phase 2 trial. Lancet Neurol. 2017 Mar;16(3):217-226. doi: 10.1016/S1474-4422(16)30357-X. Epub 2017 Feb 15. PubMed 28229893 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 1, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01955707
Lead sponsor
Biogen
Responsible party
Sponsor
First posted
Oct 7, 2013
Start date
Jan 2014
Primary completion
Feb 2015
Completion
Apr 2015
Results posted
Jul 1, 2016
Last update
Jul 1, 2016

Study contacts

Medical Director
study director · Biogen

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2016. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Stroke→

Other studies from this sponsor

Biogen

Start the discussion