Effect of Natalizumab on Infarct Volume in Acute Ischemic Stroke

Acute Ischemic Stroke Clinical Trial

— ACTION  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01955707
• Other study ID #: 101SK201
• Secondary ID: EUDRA CT NO: 201
• Status: Completed
• Phase: Phase 2
• First received: September 30, 2013
• Last updated: August 27, 2015
• Start date: January 2014
• Est. completion date: April 2015

Study information

• Verified date: April 2015
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of MedicinesGermany: Federal Institute for Drugs and Medical DevicesUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 161
• Est. completion date: April 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Ischemia
• Stroke

Intervention

Drug:
• natalizumab
Administered as described in the treatment arm
• Placebo
Matched placebo

Locations

Country	Name	City	State
Germany	Research Site	Altenburg
Germany	Research Site	Bad Neustadt
Germany	Research Site	Berlin
Germany	Research Site	Duesseldorf
Germany	Research Site	Erlangen
Germany	Research Site	Frankfurt
Germany	Research Site	Heidelberg
Germany	Research Site	Idar-Oberstein
Germany	Research Site	Leipzig
Germany	Research Site	Ludwigshafen
Germany	Research Site	Trier
Germany	Research Site	Tübingen
Spain	Research Site	Albacete
Spain	Research Site	Badalona
Spain	Research Site	Barcelona
Spain	Research Site	Barcelona
Spain	Research Site	Barcelona
Spain	Research Site	Girona
Spain	Research Site	Madrid
Spain	Research Site	Pamplona
Spain	Research Site	Santiago de Compostela
Spain	Research Site	Sevilla
Spain	Research Site	Sevilla
Spain	Research Site	Valencia
Spain	Research Site	Valladolid
United States	Research Site	Boston	Massachusetts
United States	Research Site	Dayton	Ohio
United States	Research Site	Durham	North Carolina
United States	Research Site	Golden Valley	Minnesota
United States	Research Site	Kansas City	Kansas
United States	Research Site	New York	New York
United States	Research Site	Philadelphia	Pennsylvania
United States	Research Site	Portland	Oregon
United States	Research Site	Portland	Oregon
United States	Research Site	San Diego	California
United States	Research Site	St. Louis	Missouri
United States	Research Site	Tualatin	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Countries where clinical trial is conducted

United States,  Germany,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Infarct Volume from Baseline (Diffusion-Weighted Imaging [DWI]) to Day 5 (Fluid-Attenuated Inversion Recovery [FLAIR])		Day 5	No
Secondary	Change in Infarct Volume From Baseline (DWI) to Day 30 (FLAIR)		Day 30	No
Secondary	Change in Infarct Volume From 24 hours (DWI) to Day 5 and Day 30 (FLAIR)		Up to Day 30	No
Secondary	Change in National Institute of Health Stroke Scale (NIHSS) Score from Baseline to 24 hours, Day 5, Day 30, and Day 90		Up to Day 90	No
Secondary	Modified Rankin Scale (mRS) distribution at Day 5, Day 30, and Day 90		Up to Day 90	No
Secondary	Barthel Index at Day 5, Day 30, and Day 90		Up to Day 90	No
Secondary	Number of participants who experience Adverse Events (AEs) and Serious Adverse Events (SAEs)		Up to Day 90	Yes