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Home > "E" Clinical Trials Conditions > E-Selectin Nasal instillation to Prevent Secondary Stroke  E-Selectin Nasal instillation to Prevent Secondary Stroke
E-Selectin Nasal instillation to Prevent Secondary Stroke
For Condition: Ischemic Attack, Transient,Transient
Status: Recruiting
Sponsor(s): National Institute of Neurological Disorders and Stroke (NINDS) ,
Synopsis: This study will determine the maximum safe dose of the experimental drug E-selectin that can be given to stroke patients. E-selectin causes white blood cells called lymphocytes to change so that they prevent clots from forming in the vessels that supply blood to the brain. The drug has been shown to be effective in animal models of stroke. This study will look at the safety of using this experimental drug in nasal instillation form in patients who have had a stroke or transient ischemic attack (TIA). Patients 45 years of age or older who have had a recent stroke or TIA (30 to 120 days before entering the study) due to a clot forming in a vessel that supplies blood to the brain may be eligible for this study. They must be taking at least one medication to prevent clots, such as coumadin, aspirin, ticlopidine, or others. Candidates will be screened with a physical and neurological examination, blood and urine tests, electrocardiogram (EKG), echocardiogram (ultrasound test of the heart), and magnetic resonance imaging (MRI) of the brain. Participants will be randomly assigned to receive E-selectin at a dose level of 5, 15, or 50 micrograms or a placebo (nasal drops with no active ingredient). They will instill a small, carefully premeasured amount (one dose) of fluid in their nose every other day for 10 days (total of 5 doses). This course of treatment will be repeated two times at 3-week intervals. Patients will be followed at 1 month and 3 months with a neurologic examination and blood and urine tests. They will be contacted by phone, fax, or email in between these two visits.
Details: In the United States, stroke is the third leading cause of death and the leading cause of disability. Despite the use of antithrombotic drugs for the secondary prevention of stroke, 10% of patients who experience a cerebral ischemic event will go on to have a stroke within 90 days. 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 in immune response from proinflammatory T(H)1 type to anti-inflammatory T(H)2 type at the sites of inflammation. E-selectin is an adhesion molecule expressed only on activated endothelium in response to proinflammatory cytokines. Objective. The goals of the proposed study are: (a) to test whether repeated administration of low-dose intranasal E-selectin is safe and tolerable and (b) to test whether it can induce mucosal tolerance to this compound causing a shift of immune response from T(H)1 to T(H)2 type. Study Population. One hundred patients with recent (30-120 days) stroke or TIA will be enrolled in this study. Study Design. This is a Phase 1, randomized, double-blind, placebo-controlled trial assessing safety profile of three doses of intranasal recombinant human E-selectin. Outcome Parameters. The primary safety endpoint of this study is occurrence of serious adverse events. The secondary endpoint is immune deviation from T(H)1 to T(H)2 type response. The tertiary endpoint is frequency of antibody formation to human E-selectin. Anticipated Risks and Benefits. The risks of this clinical trial are judged to represent a minor increase over minimal risk. Subjects participating in this study probably will not experience detectible personal benefits, however, this investigation may help to optimize control of their stroke-risk factors leading to a reduction in the probability of subsequent stroke or TIA. Estimate of the Outcome. We anticipate that no primary safety endpoint will be exceeded in any of the E-selectin treatment arms, and at least one of the doses of recombinant human E-selectin will induce immune deviation. Potential Meaning for the Field. This approach to stroke prevention differs from conventional antithrombotic measures in that it targets the contribution to thrombosis and hemorrhage of endothelium. It will very likely synergize with existing regimens for prophylaxis that target platelets and the coagulation cascade and will stimulate a great deal of research in this under explored area.
Eligibility:
Study Type: Interventional, Treatment, Safety
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: 1. Persons with recent (greater than 30 and less than 120 days) stroke or TIA documented by CT or MRI. To avoid the confounding variable of stroke-induced changes in the cytokine profile, patients will not be randomized until at least 30 days after their qualifying event, at which time the changes in cytokine secretion should be normalized. 2. Patients over the age of 45 years will be eligible. Because this stroke prevention strategy is directed at suppression of thrombosis and intravascular hemorrhage by suppressing blood vessel activation, patients with known atherosclerosis are likely to experience the greatest benefit from therapy. Since the etiology of stroke in persons under the age of 45 is more often related to congenital cardiac abnormalities and traumatic arterial dissections and large vessel atherosclerosis and small vessel disease (lacunes) are less common, young patients will be excluded. 3. Patients must be on at least one antithrombotic medication (warfarin, aspirin, ticlopidine, clopidogrel, aspirin+dypyridamole). Patients taking warfarin must have demonstrated a stable dose and therapeutic PT/INR prior to starting the study medication. Patients are encouraged to be on cholesterol lowering medications, antihypertensives, and oral hypoglycemic medications or insulin as appropriate. Considering the anti-Th1 and pro-Th2 tendency of HMG-CoA reductase inhibitors (statins), the use of these medications may have a confounding effect on immunologic assays. However, the multivariate ANOVA model will initially incorporate pre-baseline statin use to account for this potentially confounding variable, though this factor will be removed if it shows no significant explanatory power. 4. Patients treated with t-PA in an acute phase of stroke are eligible for the trial. 5. Patients, both male and female, of childbearing potential must use an adequate form of birth control. EXCLUSION CRITERIA: 1. Intracranial and extracranial dissection, Moyamoya disease, vasculitis, radiation-induced vasculopathy, fibromuscular dysplasia, venous thrombosis. 2. Immunosuppressive medication including: prednisone, cyclophosphamide, cyclosporine, methotrexate, azathioprine, mycophenolate mofetil, anti-CD3 moab (Othoclone OKT3), takrolimus (FK506), sirolimus, anti-IL2r moab (simulect, zenapax), etanercept, infliximab, lenercept, thymoglobulin; thalidomide. 3. Known autoimmune diseases (RA, LE, MS, Myasthenia Gravis, etc.). 4. Cancer or lymphoproliferative diseases. 5. Thrombocytopenia (platelets less than 100,000). 6. HIV or other known immunodeficiencies. 7. Recent major surgery (within one month). 8. Systemic infections, or severe focal or upper respiratory infections (URI). 9. Alcohol or substance abuse. 10. Dementia or psychiatric problems (determined by examination, mini-mental status test and consent interview) that prevent the patient from providing informed consent or following an outpatient program reliably. 11. Pregnancy (urine pregnancy test will be given to women of childbearing potential). 12. Severe rhinopathy or sinusitis. 13. Continuing use of any other over the counter, prescribed or recreational intranasal drug. 14. History of grade 3 epistaxis within 1 month. 15. Patients who have been exposed to an investigational drug within the 30 days prior to screening for this study. 16. Patients for whom surgery (e.g. carotid or cardiac surgery) or endovascular intervention is planned during the study period.
Total Enrollment: 100
Location and Contact Information:
National Institute of Neurological Disorders and Stroke (NINDS) *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Patient and Public Liaison Office 1-800-411-1222
Additional Information:
Study ID Numbers: 030293; 03-N-0293
Study Start Date: September 10, 2003
Record last reviewed: September 4, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00069069
Other Ischemic Attack, Transient Studies:
1. Safety and Effectiveness of NXY-059 for the treatment of patients who have suffered from a stroke.
2. Carotid Occlusion Surgery Study
3. E-Selectin Nasal instillation to Prevent Secondary Stroke
Related Studies:
Other Ischemic Attack, Transient Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
E-Selectin Nasal instillation to Prevent Secondary Stroke
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