Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00012454
Status:
TERMINATED
Last Update Posted:
2010-05-04
First Post:
2001-03-09
Brief Title:
E-Selectin Nasal Spray to Prevent Stroke Recurrence
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Induction of Mucosal Tolerance to E-Selectin for the Secondary Prevention of Stroke
Status:
TERMINATED
Status Verified Date:
2010-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
In the United States stroke is the third leading cause of death and the leading cause of disability Despite the success of recent clinical trials of antithrombotic drugs for the secondary prevention of stroke annually about 10 of patients with recent cerebrovascular accidents have recurrent strokes The development of new treatment strategies for the secondary prevention of stroke is an important issue for modern medicine There is increasing evidence that inflammation at the sites of endothelial activation plays an important role in the pathogenesis of stroke Control of molecular inflammation at the sites of endothelial activation can be achieved by induction of mucosal tolerance The induction of mucosal tolerance with repeated low-dose intranasal administration of antigen causes a shift of immune response from proinflammatory TH1 type to anti-inflammatory TH2 type at the sites of inflammation E-selectin is an adhesion molecule expressed only on activated endothelium in response to proinflammatory cytokines The major goal of proposed study is to test whether repeated administration of low-dose intranasal E-selectin can induce mucosal tolerance to this compound causing a shift of immune response from TH1 to TH2 type in patients with recent stroke or TIA and secondly to evaluate the safety and tolerability of this strategy for the secondary prevention of stroke
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 01-N-0110 | None | None | None |