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

Biogen

Status and phase: Completed; Phase 2

Conditions: Acute Ischemic Stroke

Treatments: Drug: Placebo; Drug: natalizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT01955707

101SK201

EUDRA CT NO: 2013-001514-15

Details and patient eligibility

About

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.

Enrollment: 161 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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161 participants in 2 patient groups, including a placebo group

natalizumab

Experimental group

Description:

300 mg single intravenous (IV) injection

Treatment:

Drug: natalizumab

Placebo

Placebo Comparator group

Description:

A single IV dose of placebo

Treatment:

Drug: Placebo