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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Biogen Idec
Sponsor:
Information provided by (Responsible Party):
Biogen Idec
ClinicalTrials.gov Identifier:
NCT01955707
First received: September 30, 2013
Last updated: August 18, 2014
Last verified: August 2014

September 30, 2013
August 18, 2014
January 2014
May 2015   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01955707 on ClinicalTrials.gov Archive Site
  • 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 subjects who experience Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Up to Day 90 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Effect of Natalizumab on Infarct Volume in Acute Ischemic Stroke
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

The primary objective of the study is to determine whether one 300 mg dose of intravenous (IV) BG00002 reduces change in infarct volume from Baseline to Day 5 on magnetic resonance imaging (MRI) in subjects 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 BG00002 on change in infarct volume from Baseline to Day 30; To assess efficacy of BG00002 on change in infarct volume from 24 hours to Day 5 and Day 30; To assess the efficacy of BG00002 on clinical measures of stroke outcome; To assess the safety of BG00002 in subjects with acute ischemic stroke

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Acute Ischemic Stroke
  • Biological: BG00002 (Natalizumab)
    300 mg single intravenous injection
  • Drug: Placebo
    single intravenous injection
  • Experimental: BG00002
    a single intravenous dose of BG00002
    Intervention: Biological: BG00002 (Natalizumab)
  • Placebo Comparator: Placebo
    a single intravenous dose of placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
August 2015
May 2015   (final data collection date for primary outcome measure)

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.

Both
18 Years to 85 Years
No
Contact: Biogen Idec clinicaltrials@biogenidec.com
United States,   Germany,   Spain
 
NCT01955707
101SK201, EUDRA CT NO: 2013‐001514‐15
Yes
Biogen Idec
Biogen Idec
Not Provided
Study Director: Medical Director Biogen Idec
Biogen Idec
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP