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Safety and Efficacy of Intravenous Natalizumab in Acute Ischemic Stroke (ACTION2)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02730455
First Posted: April 6, 2016
Last Update Posted: October 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Biogen
  Purpose
The primary objective of the study is to assess the clinical effects of natalizumab versus placebo in acute ischemic stroke on clinical measures of functional independence and activities of daily living. The secondary objective of the study is to explore dose and exposure response and the clinical treatment effects of natalizumab versus placebo in acute ischemic stroke on the following: measures of independence, activities of daily living, neurologic function, quality of life, cognition, and safety and tolerability

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multicenter, Double-Blind, Placebo-Controlled, Randomized, Parallel-Group, Dose-Ranging Study to Evaluate the Safety and Efficacy of Intravenous Natalizumab (BG00002) in Acute Ischemic Stroke

Resource links provided by NLM:


Further study details as provided by Biogen:

Primary Outcome Measures:
  • Composite global measure of functional disability based on a score of 0 or 1 on the modified Rankin Scale (mRS) [ Time Frame: Day 5 to Day 90 ]
    The mRS measures independence, with specific tasks pre- and post-stroke. The scale consists of 7 grades, from 0 to 6, with 0 corresponding to no symptoms and 6 corresponding to death. The mRS takes less than 5 minutes to administer and will be completed by a telephone interview for any participants who fail to attend their Day 90 follow-up or early termination visit.

  • Score of ≥95 on the Barthel Index (BI) [ Time Frame: Day 5 to Day 90 ]
    The BI consists of 10 items that measure a person's daily functioning, specifically the activities of daily living and mobility. The items include feeding, moving from wheelchair to bed and returning, grooming, transferring to and from a toilet, bathing, walking on a level surface, going up and down stairs, dressing, and maintaining continence of bowels and bladder. Each item is measured on a 10 point scale with a maximum score of 100 with higher scores indicating higher independence of the participant in performing these tasks. The BI takes less than 5 minutes to administer.


Secondary Outcome Measures:
  • modified Rankin Scale (mRS) score [ Time Frame: Day 5 to Day 90 ]
  • Barthel Index (BI) score [ Time Frame: Day 5 to Day 90 ]
  • Stroke Impact Scale-16 (SIS-16) score [ Time Frame: Day 5 to Day 90 ]
    The SIS-16 is a 16-item physical dimension instrument that measures 16 physical aspects rated on a scale of 1 (could not do at all) to 5 (not difficult at all). The SIS-16 takes less than 5 minutes to administer and will be completed by a telephone interview for any participants who fail to attend their Day 90 follow-up or early termination visit.

  • Montreal Cognitive Assessment (MoCA) score [ Time Frame: Day 5 to Day 90 ]
    The MoCA is a global cognitive screening test which screens 8 domains of psychometric properties: visuospatial/executive, naming, memory, attention, language, abstraction, delayed recall, and orientation with a highest score of 30 points. This assessment takes approximately 10 minutes to administer.

  • Number of participants experiencing adverse events (AE) [ Time Frame: Baseline to Day 90 ]
  • Number of participants experiencing serious adverse events (SAE) [ Time Frame: Baseline to Day 90 ]
  • National Institute of Health Stroke Scale (NIHSS) score [ Time Frame: Baseline to Day 90 ]
    The NIHSS is used to assess the effects of acute cerebral infarction. This score rates the participant's ability to answer questions and perform activities relating to level of consciousness, language, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, sensory loss, and extinction and inattention (formerly neglect). This is a 15 item questionnaire on a rating of 3 to 5 grades, with 0 as normal and a maximum possible of 42 for all items and takes about 10 minutes to administer.


Enrollment: 270
Actual Study Start Date: July 18, 2016
Estimated Study Completion Date: February 28, 2018
Estimated Primary Completion Date: February 28, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: natalizumab high dose
Single IV (intravenous) dose natalizumab at baseline at one of two treatment windows, either within 9 hours of last known normal (LKN) or between 9-24 hours after LKN.
Drug: natalizumab
Administered as specified in the treatment arm
Other Name: BG00002
Experimental: natalizumab low dose
Single IV (intravenous) dose natalizumab at baseline at one of two treatment windows, either within 9 hours of last known normal (LKN) or between 9-24 hours after LKN.
Drug: natalizumab
Administered as specified in the treatment arm
Other Name: BG00002
Experimental: Placebo
Single dose of Placebo IV at baseline at one of two treatment windows, either within 9 hours of last known normal (LKN) or between 9-24 hours after LKN.
Drug: Placebo
Matched placebo

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Clinical diagnosis of supratentorial acute ischemic stroke defined by LKN ≤24 hours prior to study treatment initiation.
  • Score of 5 to 23 points, inclusive, on the NIHSS at Screening for subjects initiating treatment ≤9 hours from LKN. Note: NIHSS eligibility must be confirmed within 60 minutes prior to randomization.
  • Score of 5 to 15 points, inclusive, on the NIHSS at Screening for subjects initiating treatment >9 to ≤24 hours from LKN. Note: NIHSS eligibility must be confirmed within 60 minutes prior to randomization.
  • Prior to index stroke, patient was able to perform basic activities of daily living without assistance: dressing, eating, walking, bathing, and using the toilet.
  • For those subjects who underwent a cranial MRI, there is at least 1 acute infarct with a diameter of ≥2 cm on baseline brain diffusion-weighted imaging.

Key Exclusion Criteria:

  • Lacunar or isolated brainstem or cerebellar stroke based on clinical assessment and available acute imaging studies performed under the standard of care.
  • Presence of acute intracranial hemorrhage on acute brain CT or MRI. However, petechial hemorrhages of ≤1 cm are not exclusionary.
  • Severe stroke defined by imaging criteria based on either one of the following:
  • Alberta Stroke Program Early CT (ASPECT) score of 0 to 4 based on head CT or
  • Acute infarct volume on MRI diffusion weighed imaging greater than or equal to 70 mL
  • Seizure at the onset of stroke.
  • Known history of prior treatment with natalizumab.
  • Known history of active viral hepatitis B or C.
  • Signs and symptoms of active or acute infection.

NOTE: Other protocol-defined inclusion/exclusion criteria may apply.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02730455


  Show 67 Study Locations
Sponsors and Collaborators
Biogen
Investigators
Study Director: Medical Director Biogen
  More Information

Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT02730455     History of Changes
Other Study ID Numbers: 101SK202
2015-004783-11 ( EudraCT Number )
First Submitted: March 10, 2016
First Posted: April 6, 2016
Last Update Posted: October 17, 2017
Last Verified: October 2017

Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Biogen:
Stroke

Additional relevant MeSH terms:
Stroke
Ischemia
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia
Natalizumab
Immunologic Factors
Physiological Effects of Drugs