ID

28370

Description

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. https://clinicaltrials.gov/ct2/show/study/NCT02730455.

Link

https://clinicaltrials.gov/ct2/show/study/NCT02730455

Keywords

Versions (1)
  1. 1/8/18 1/8/18 -
Copyright Holder

Biogen

Uploaded on

January 8, 2018

DOI

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License

Creative Commons BY-NC 3.0
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Eligibility criteria ACTION 2 Acute Ischemic Stroke NCT02730455

English

Eligibility criteria ACTION 2 Acute Ischemic Stroke NCT02730455

1 forms  
Key Inclusion Criteria
Description

Key Inclusion Criteria

Age 18 to 80 Years
Description

Age

Data type

boolean

Clinical diagnosis of supratentorial acute ischemic stroke defined by LKN ≤24 hours prior to study treatment initiation
Description

diagnosis of stroke

Data type

boolean

Score of 5 to 23 points, inclusive, on the NIHSS at Screening for subjects initiating treatment ≤9 hours from LKN
Description

Note: NIHSS eligibility must be confirmed within 60 minutes prior to randomization

Data type

boolean

Score of 5 to 15 points, inclusive, on the NIHSS at Screening for subjects initiating treatment >9 to ≤24 hours from LKN
Description

Note: NIHSS eligibility must be confirmed within 60 minutes prior to randomization

Data type

boolean

Prior to index stroke, patient was able to perform basic activities of daily living without assistance: dressing, eating, walking, bathing, and using the toilet
Description

basic activities of daily living

Data type

boolean

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
Description

acute infarct diameter MRI

Data type

boolean

Key Exclusion Criteria
Description

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
Description

brainstem or cerebellar stroke

Data type

boolean

Presence of acute intracranial hemorrhage on acute brain CT or MRI. However, petechial hemorrhages of ≤1 cm are not exclusionary
Description

acute intracranial hemorrhage

Data type

boolean

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
Description

Severe stroke

Data type

boolean

Seizure at the onset of stroke
Description

Seizure

Data type

boolean

Known history of prior treatment with natalizumab
Description

natalizumab

Data type

boolean

Known history of active viral hepatitis B or C
Description

hepatitis B or C

Data type

boolean

Signs and symptoms of active or acute infection
Description

infection

Data type

boolean

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Similar models

Eligibility criteria ACTION 2 Acute Ischemic Stroke NCT02730455

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Key Inclusion Criteria
Age
Item
Age 18 to 80 Years
boolean
diagnosis of stroke
Item
Clinical diagnosis of supratentorial acute ischemic stroke defined by LKN ≤24 hours prior to study treatment initiation
boolean
NIHSS score within 9 hours of last known normal
Item
Score of 5 to 23 points, inclusive, on the NIHSS at Screening for subjects initiating treatment ≤9 hours from LKN
boolean
NIHSS score 9-24 hours after last known normal
Item
Score of 5 to 15 points, inclusive, on the NIHSS at Screening for subjects initiating treatment >9 to ≤24 hours from LKN
boolean
basic activities of daily living
Item
Prior to index stroke, patient was able to perform basic activities of daily living without assistance: dressing, eating, walking, bathing, and using the toilet
boolean
acute infarct diameter MRI
Item
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
boolean
Item Group
Key Exclusion Criteria
brainstem or cerebellar stroke
Item
Lacunar or isolated brainstem or cerebellar stroke based on clinical assessment and available acute imaging studies performed under the standard of care
boolean
acute intracranial hemorrhage
Item
Presence of acute intracranial hemorrhage on acute brain CT or MRI. However, petechial hemorrhages of ≤1 cm are not exclusionary
boolean
Severe stroke
Item
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
boolean
Seizure
Item
Seizure at the onset of stroke
boolean
natalizumab
Item
Known history of prior treatment with natalizumab
boolean
hepatitis B or C
Item
Known history of active viral hepatitis B or C
boolean
infection
Item
Signs and symptoms of active or acute infection
boolean
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