Effect of Natalizumab on Infarct Volume in Acute Ischemic Stroke
Completed · Phase 2 · Has a placebo group
Conditions studied: Acute Ischemic Stroke
In brief
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.
Key facts
- Study ID
- NCT01955707
- Run by
- Biogen
- People needed
- 161
- Starts
- 2014-01-01
- Expected to finish
- 2015-04-01
- Last updated by the study team
- 2016-07-01
Who can join
Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Research Site — San Diego, California, United States
- Research Site — Gainesville, Florida, United States
- Research Site — Kansas City, Kansas, United States
- Research Site — Boston, Massachusetts, United States
- Research Site — Golden Valley, Minnesota, United States
- Research Site — St Louis, Missouri, United States
- Research Site — Lake Success, New York, United States
- Research Site — New York, New York, United States
- Research Site — Durham, North Carolina, United States
- Research Site — Akron, Ohio, United States
- Research Site — Dayton, Ohio, United States
- Research Site — Toledo, Ohio, United States
- Research Site — Portland, Oregon, United States
- Research Site — Tualatin, Oregon, United States
- Research Site — Philadelphia, Pennsylvania, United States
- Research Site — Nashville, Tennessee, United States
- Research Site — Dallas, Texas, United States
- Research Site — Charlottesville, Virginia, United States
- Research Site — Milwaukee, Wisconsin, United States
- Research Site — Altenburg, Germany
- Research Site — Bad Neustadt an der Saale, Germany
- Research Site — Berlin, Germany
- Research Site — Bonn, Germany
- Research Site — Düsseldorf, Germany
- Research Site — Erlangen, Germany
Full record on ClinicalTrials.gov
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