Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Effect of Natalizumab on Infarct Volume in Acute Ischemic Stroke (ACTION)

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Biogen Idec Identifier:
First received: September 30, 2013
Last updated: February 5, 2015
Last verified: February 2015

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

Condition Intervention Phase
Acute Ischemic Stroke
Biological: natalizumab
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Double-Blind, Placebo-Controlled, Randomized, Parallel-Group Study to Evaluate the Safety and Efficacy of Intravenous Natalizumab (BG00002) on Reducing Infarct Volume in Acute Ischemic Stroke

Resource links provided by NLM:

Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • Change in Infarct Volume from Baseline (Diffusion-Weighted Imaging [DWI]) to Day 5 (Fluid-Attenuated Inversion Recovery [FLAIR]) [ Time Frame: Day 5 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Infarct Volume From Baseline (DWI) to Day 30 (FLAIR) [ Time Frame: Day 30 ] [ Designated as safety issue: No ]
  • Change in Infarct Volume From 24 hours (DWI) to Day 5 and Day 30 (FLAIR) [ Time Frame: Up to Day 30 ] [ Designated as safety issue: No ]
  • Change in National Institute of Health Stroke Scale (NIHSS) Score from Baseline to 24 hours, Day 5, Day 30, and Day 90 [ Time Frame: Up to Day 90 ] [ Designated as safety issue: No ]
  • Modified Rankin Scale (mRS) distribution at Day 5, Day 30, and Day 90 [ Time Frame: Up to Day 90 ] [ Designated as safety issue: No ]
  • Barthel Index at Day 5, Day 30, and Day 90 [ Time Frame: Up to Day 90 ] [ Designated as safety issue: No ]
  • Number of participants who experience Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Up to Day 90 ] [ Designated as safety issue: Yes ]

Enrollment: 161
Study Start Date: January 2014
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: natalizumab
a single intravenous dose of natalizumab
Biological: natalizumab
300 mg single intravenous injection
Other Names:
  • Tysabri
  • BG00002
Placebo Comparator: Placebo
a single intravenous dose of placebo
Drug: Placebo
single intravenous injection


Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.

  Contacts and Locations
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Please refer to this study by its identifier: NCT01955707

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Sponsors and Collaborators
Biogen Idec
Study Director: Medical Director Biogen Idec
  More Information

No publications provided

Responsible Party: Biogen Idec Identifier: NCT01955707     History of Changes
Other Study ID Numbers: 101SK201, EUDRA CT NO: 2013‐001514‐15
Study First Received: September 30, 2013
Last Updated: February 5, 2015
Health Authority: Spain: Spanish Agency of Medicines
Germany: Federal Institute for Drugs and Medical Devices
United States: Food and Drug Administration

Additional relevant MeSH terms:
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Vascular Diseases processed this record on February 27, 2015