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NCT01955707 · ClinicalTrials.gov registry record · Phase 2
Effect of Natalizumab on Infarct Volume in Acute Ischemic Stroke
A Phase 2 study, sponsored by Biogen.
- Completed
- Registry status
- Phase 2
- Development phase
- 161
- Enrollment target
NCT01955707: Completed Phase 2 study, sponsored by Biogen.
NCT01955707 is a Phase 2 study that has completed, run by Biogen. The registered enrollment target is 161 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (21% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01955707, a Phase 2 study, has completed, sponsored by Biogen.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 161 participants
- Enrollment target
Study 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.
Primary Outcome
Relative growth of infarct volume from Baseline (relative growth = FLAIR at Day 5 divided by Baseline DWI). Geometric mean calculated as the exponential of the mean log relative growth.
Interventions
- DRUG Placebo
- DRUG natalizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 161 participants |
| Start Date | 2014-01 |
| Est. Completion | 2015-04 |
| Phase | Phase 2 |
What the finished NCT01955707 record still lists
NCT01955707 is an interventional study that assigns participants to a tested intervention. The registered 161 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (21% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01955707 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01955707 about?
NCT01955707 is a clinical study titled "Effect of Natalizumab on Infarct Volume in Acute Ischemic Stroke". 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 the...
What is the current status of trial NCT01955707?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 161 participants. The study started on 2014-01. Estimated completion is 2015-04.
What interventions are being tested in trial NCT01955707?
The interventions under investigation include: Placebo (DRUG), natalizumab (DRUG).
Who is sponsoring clinical trial NCT01955707?
This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01955707's enrollment target sits among peer trials
161 422nd of 2000 higher than 1,579 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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