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Completed Phase 2 Interventional Results available

Effect of Natalizumab on Infarct Volume in Acute Ischemic Stroke

ClinicalTrials.gov ID: NCT01955707

Public ClinicalTrials.gov record NCT01955707. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Nov 10, 2026, 5:05 PM EST

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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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT01955707
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Biogen
Industry
Enrollment
161 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years to 85 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jan 2014 (Type not available)
Primary completion
Feb 2015 (Actual)
Completion
Apr 2015 (Actual)
Last update posted
Jul 1, 2016

2014 – 2015

United States locations

U.S. sites
19
U.S. states
15
U.S. cities
19
Facility City State ZIP Site status
Research Site San Diego California — —
Research Site Gainesville Florida — —
Research Site Kansas City Kansas 66160 —
Research Site Boston Massachusetts 02114 —
Research Site Golden Valley Minnesota 55422 —
Research Site St Louis Missouri 63110 —
Research Site Lake Success New York — —
Research Site New York New York 10032 —
Research Site Durham North Carolina 27710 —
Research Site Akron Ohio — —
Research Site Dayton Ohio 45409 —
Research Site Toledo Ohio — —
Research Site Portland Oregon — —
Research Site Tualatin Oregon 97062 —
Research Site Philadelphia Pennsylvania 19104 —
Research Site Nashville Tennessee — —
Research Site Dallas Texas — —
Research Site Charlottesville Virginia — —
Research Site Milwaukee Wisconsin — —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 31 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01955707, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jul 1, 2016 · Synced Nov 10, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01955707 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →