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
  Purpose

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


Condition Intervention Phase
Acute Ischemic Stroke
Biological: BG00002 (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 subjects who experience Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Up to Day 90 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 200
Study Start Date: January 2014
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BG00002
a single intravenous dose of BG00002
Biological: BG00002 (Natalizumab)
300 mg single intravenous injection
Placebo Comparator: Placebo
a single intravenous dose of placebo
Drug: Placebo
single intravenous injection

  Eligibility

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01955707

Contacts
Contact: Biogen Idec clinicaltrials@biogenidec.com

  Show 52 Study Locations
Sponsors and Collaborators
Biogen Idec
Investigators
Study Director: Medical Director Biogen Idec
  More Information

No publications provided

Responsible Party: Biogen Idec
ClinicalTrials.gov Identifier: NCT01955707     History of Changes
Other Study ID Numbers: 101SK201, EUDRA CT NO: 2013‐001514‐15
Study First Received: September 30, 2013
Last Updated: August 18, 2014
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:
Ischemia
Stroke
Cerebral Infarction
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on August 28, 2014