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NCT00097318 · ClinicalTrials.gov registry record · Phase 1
Safety Study of Interferon Beta 1a to for Acute Stroke
A Phase 1 study, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- Completed
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
NCT00097318: Completed Phase 1 study, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
NCT00097318 is a Phase 1 study that has completed, run by National Institute of Neurological Disorders and Stroke (NINDS). The registered enrollment target is 60 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00097318, a Phase 1 study, has completed, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
Study Summary
This study will examine the safety of the drug interferon beta 1a in patients with acute ischemic stroke to determine the highest dose patients can tolerate without serious side effects and to determine the best way to give the medication. Ischemic stroke is caused by a blood clot blocking the flow of blood to brain tissue, causing loss or impairment of bodily functions governed by the affected part of the brain. Interferon beta 1a is approved for use in patients with multiple sclerosis to prevent further brain injury caused by inflammation; the drug may also help prevent further brain injury in patients with acute stroke. Patients between 18 and 85 years of age who have had a stroke and who can begin taking the study drug within 24 hours of onset of stroke symptoms may be eligible for this study. Candidates are screened with a medical history, physical examination and neurological examinations, blood tests, electrocardiogram, and brain imaging with magnetic resonance imaging (MRI) or computed tomography (CT) scans. Participants are randomly assigned to receive either interferon beta 1a or placebo (an inactive substance). For every five patients enrolled, four receive the study drug and one receives placebo. The dose of interferon beta 1a is increased in successive groups of patients, so that the first group to enter the study receives 11 micrograms (mcg) of the drug, the next receives 22 mcg, then 44 mcg, 66 mcg, and 88 mcg. All patients receive their first dose intravenously (through a vein); additional doses are given subcutaneously (under the skin). During their hospital stay all participants receive standard medical care for stroke, have neurological checks every 6 hours, and have continuous heart monitoring. To prevent fever, they receive medication, such as Tylenol, before each dose of interferon beta 1a or placebo and every 6 hours as needed while taking the study drug. Routine blood tests are done at 3 and 7 days after the first dose of study drug (or at
Interventions
- DRUG Interferon beta-1a
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2004-11-17 |
| Est. Completion | 2011-04-08 |
| Phase | Phase 1 |
What the finished NCT00097318 record still lists
NCT00097318 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 1 intervention - of which Interferon beta-1a is the first listed.
NCT00097318 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00097318 about?
NCT00097318 is a clinical study titled "Safety Study of Interferon Beta 1a to for Acute Stroke". This study will examine the safety of the drug interferon beta 1a in patients with acute ischemic stroke to determine the highest dose patients can tolerate without serious side effects and to determine the best way to give the medication. Ischemic stroke is caused by a blood clot blocking the flow ...
What is the current status of trial NCT00097318?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2004-11-17. Estimated completion is 2011-04-08.
What interventions are being tested in trial NCT00097318?
The interventions under investigation include: Interferon beta-1a (DRUG).
Who is sponsoring clinical trial NCT00097318?
This trial is sponsored by National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00097318's enrollment target sits among peer trials
60 831st of 2000 higher than 1,106 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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