Effect of Natalizumab on Infarct Volume in Acute Ischemic Stroke
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.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
- Enrollment
- 161 participants
Conditions and interventions
Conditions
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
- Dec 31, 2013
- Primary completion
- Jan 31, 2015
- Completion
- Mar 31, 2015
- Last update posted
- Jun 30, 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 Jun 30, 2016 · Synced Sep 23, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01955707 live on ClinicalTrials.gov.