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NCT00012454 · ClinicalTrials.gov registry record · Phase 2
E-Selectin Nasal Spray to Prevent Stroke Recurrence
A Phase 2 study, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- Terminated
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
NCT00012454 is a Phase 2 study that was terminated before completion, run by National Institute of Neurological Disorders and Stroke (NINDS). The registered enrollment target is 60 participants.
The verdict
NCT00012454, a Phase 2 study, was terminated before completion, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
Study Summary
This study will test the safety and effectiveness of a protein called E-selectin, given as a nasal spray, in preventing the formation of blood clots that can cause stroke. In animal studies, animals that received E-selectin in the nose on a regular schedule had almost no strokes compared with those that did not receive it. Patients over age 45 who have had a stroke or transient ischemic attack (TIA) within 1 to 4 months of this study may be eligible to participate. Candidates will be screened with a review of their past medical records and neurologic and medical evaluations that may include magnetic resonance imaging (MRI) of the brain, ultrasound or magnetic resonance angiography (a type of MRI) of the carotid arteries (arteries in the neck that supply blood to the brain), echocardiography (ultrasound test of the heart), electrocardiography (EKG) and blood tests. Participants will have a blood and urine test and will be assigned to one of four treatment groups. Patients in each group will spray a small amount of fluid into their nose according to the following schedule: 5 doses once every other day for 10-days, followed in 3 weeks by another 5 doses every other day for 10-days, followed in 3 weeks by a final series of 5 doses every other day for 10 days. The spray for patients in each group contains the following: * Group 1 - fluid with low dose of E-selectin * Group 2 - fluid with medium dose of E-selectin * Group 3 - fluid with high dose of E-selectin * Group 4 - fluid with no E-selectin Patients will be seen for follow-up visits at 1 month and 3 months after starting E-selectin therapy. The visits will include a neurologic examination and blood and urine tests. Patients will be contacted by phone, fax or e-mail in between the 1- and 3-month visits.
Interventions
- DRUG E-Selectin nasal spray
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2001-03 |
| Est. Completion | 2004-02 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00012454
The ClinicalTrials.gov registry entry for NCT00012454 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which E-Selectin nasal spray is the first listed.
NCT00012454 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00012454 about?
NCT00012454 is a clinical study titled "E-Selectin Nasal Spray to Prevent Stroke Recurrence". This study will test the safety and effectiveness of a protein called E-selectin, given as a nasal spray, in preventing the formation of blood clots that can cause stroke. In animal studies, animals that received E-selectin in the nose on a regular schedule had almost no strokes compared with those ...
What is the current status of trial NCT00012454?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2001-03. Estimated completion is 2004-02.
What interventions are being tested in trial NCT00012454?
The interventions under investigation include: E-Selectin nasal spray (DRUG).
Who is sponsoring clinical trial NCT00012454?
This trial is sponsored by National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total clinical trials registered on ClinicalTrials.gov.
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