Current Clinical Trials at Miami Valley Hospital 

Clinical trials are research studies designed to evaluate the effectiveness of new drugs or treatment strategies. Clinical trials deliver care in a consistent and structured method so all participants in the trial get the most up-to-date standard of care, in addition to treatments that are not yet widely available. They are an integral component for improving the treatment of neurological conditions. Your physician will determine if you are a candidate for a clinical trial and discuss your options with you and your loved ones.

NBP (n-Butylphthalide) Study

A Phase 2, multicenter, randomized, double-blind, placebo-controlled, add-on to standard-of-care study of n-Butylphthalide (NBP) softgel capsules for treatment of mild to moderate acute ischemic stroke in adult subjects.

The compound n-butylphthalide (NBP) is being develop for the treatment of acute ischemic stroke within a 24-hour window of time from the onset of stroke. The primary goal of this study is to evaluate the safety of NBP treatment compared with placebo in subjects with mild to moderate acute ischemic stroke. Subjects will be randomly assigned at a ratio of 1:1 to placebo or NBP and treated for 30 days. All randomized subjects will receive standard supportive medical care for treatment of acute ischemic stroke throughout the study. 

Status: Open
Number of Patients to be Enrolled: Approximately 400

CODMAN ENTERPRISE®

A prospective, multi-center, single arm study to evaluate the safety and effectiveness of the CODMAN ENTERPRISE® Vascular Reconstruction Device and Delivery System when used in conjunction with endovascular coil embolization in the treatment of wide-necked saccular intracranial aneurysms.

Status: Open
Number of patients to be enrolled: 5
Number of study sites: 27 Sites

Previous Clinical Trials

Many clinical trials accrue a set number of people. After that time, the trials are closed and no longer enroll new patients. Below is a list of clinical trials in which we have participated, but that are closed to new patients.

Respect ESUS 

Respect ESUS randomized double-blind evaluation in secondary stroke prevention comparing the efficacy and safety of the oral thrombin inhibitor dabigatran etexilate (110mg or 150 mg, oral bid) versus acetylsalicylic acid (100 mg oral every day) in patients with embolic stroke of undetermined source.

POINT: Platelet-Oriented Inhibition in New TIA and Minor Ischemic Stroke Trial

The purpose of this study is to determine the safety and effectiveness of the combination of low-dose aspirin and a medication called clopidogrel (also known by the brand name Plavix®) in reducing the risk of stroke, heart attacks, and other complications in patients who have just had a TIA (transient ischemic attack) or minor ischemic stroke. Each participant will be involved in the study for 90 days. POINT is a randomized, double-blind, multicenter clinical trial.

Status: Closed
Number of patients to be enrolled: 5,840 
Number of study sites: 150 in the U.S., Canada, Australia and New Zealand
Biogen IIB: A multicenter, double blind placebo-controlled randomized parallel-group, dose ranging study to evaluate the safety and efficacy of intravenous

Natalizumab In Acute Ischemic Stroke

Natalizumab is a humanized monoclonal antibody approved for the treatment of both relapsing multiple sclerosis and Crohn’s disease that blocks α4β1- or α4β7-integrin mediated adhesion of leukocytes to vascular endothelial cells and inhibits the transmigration of leukocytes into inflamed parenchymal tissue. 

The study (101SK201) will assess dose response and overall safety and efficacy of natalizumab in subjects with acute ischemic stroke. Time dependency of treatment effects will also be assessed through a treatment window of up to 9 hours from last known normal (LKN). 

The primary objective of the study is to assess the effects of natalizumab versus placebo in acute ischemic stroke on clinical measures of independence and activities of daily life. 

Status: Closed. 

MISTIE III: Minimally Invasive Surgery Plus rt-PA for ICH Evacuation Phase III

The purpose of this trial was to determine whether using an investigational surgical procedure can improve outcomes for patients with intracerebral hemorrhage. It is a Phase III, randomized, case-controlled, open-label clinical trial of minimally invasive surgery plus recombinant human tissue plasminogen activator (rt-PA) in the treatment of intracerebral hemorrhage. 

Status: Closed
Number of patients to be enrolled: 500
Number of study sites: 77 worldwide

PRISMS: A Study Of the Efficacy And Safety Of Activase In Patients With Mild Stroke: Rapidly Improving Symptoms And Neurologic Deficits

The purpose of this study is to evaluate the effectiveness and safety of intravenous Activase (a clot-busting drug) in patients with mild acute ischemic strokes that do not appear to be clearly disabling. PRISMS is a double-blind, multicenter, randomized, Phase IIIb study.

Status: Closed
Number of patients to be enrolled: Approximately 948
Number of study sites: Approximately 81 in the U.S.

SHINE: Stroke Hyperglycemia Insulin Network Effort 

The purpose of this study is to determine if the treatment of hyperglycemic acute ischemic stroke patients with targeted glucose concentration (80mg/dL – 120 mg/dL) will be safe and result in an improved three-month outcome after stroke. SHINE is a multicenter, randomized, controlled clinical trial. Eligible subjects must be within 12 hours of stroke symptom onset and have diabetes and glucose concentrations of over 110 mg/dL on initial evaluation.

Status: Closed
Number of patients to be enrolled: 1,400
Number of study sites: Approximately 60 in the U.S.

Effect Of Natalizumab On Infarct Volume In Acute Ischemic Stroke (ACTION) ACTION (101SK201)

The purpose of this trial was to determine whether an investigative drug is potentially a neuro-protective therapy following a stroke. This multi-center, double-blind, placebo-controlled, randomized, parallel-group study is evaluating the safety and efficacy of intravenous natalizumab (BG00002) on reducing infarct volume in acute ischemic stroke.

Status: Closed
Number of study sites: 52 in the U.S. and Europe

THERAPY: Assess the Penumbra System in the Treatment of Acute Stroke

The purpose of this trial was to investigate the added benefit of surgical stroke rescue in addition to intravenous medications for stroke treatment. The trial is assessing the safety and effectiveness of the Penumbra System as an adjunctive treatment to intravenous (IV) recombinant human tissue plasminogen activator (rtPA) in patients with acute ischemic stroke from large vessel occlusion in the brain. IV rtPA is the only drug approved for the treatment of acute ischemic stroke, but it does not work very well in cases where the stroke is caused by a large vessel occlusion. The hypothesis being tested is to determine if the addition of a treatment by a mechanical thrombectomy device like the Penumbra System can improve the clinical outcome of the patient over just using IV rtPA alone.

Status: Closed
Number of study sites: 55 in the U.S. and Europe

About the WSU & Premier Neuroscience Institute

The Wright State University and Premier Neuroscience Institute is a major public-private initiative that partners the Dayton region’s strongest biomedical research institution with the clinical resources of the region’s leading hospital system. Premier Health has made a major investment to create a new Department of Neurology within the WSU Boonshoft School of Medicine. The investment includes long-term support for clinical neurologists and university-based neuroscientists performing critical research of stroke and movement disorders.

The Boonshoft School of Medicine has talented neuroscientists, along with excellent core resources and equipment for cutting-edge laboratory research, including microscopic imaging, genomics, proteomics, and electrophysiology. A primary focus of their research is nervous system disorders that affect movement. Premier Health has a large and diverse patient base that provides an excellent opportunity for high-quality research and clinical trials.

Goals of the Neuroscience Institute

WSU and Premier are investing significant fiscal resources to provide improved neurological care as well as longer-term clinical trials and continuing research for the Dayton community. By leveraging WSU’s considerable National Institutes of Health-funded research strengths along with Premier’s extensive clinical resources, the Neuroscience Institute plans to make breakthroughs in a broad range of neurologic disorders.

Benefits To the Dayton Community

The Neuroscience Institute is the centerpiece for conducting neuroscience research, and it promotes ways to move the results of that research directly from the laboratory to the bedside. The institute provides outstanding neurological care to the community and creates a clinical and research enterprise that is pivotal for the region's economic growth. Joint research activities and related investments are having a direct economic impact on the community, amounting to tens of millions of dollars. The emergence of a strong neuroscience institute through this collaboration is a watershed accomplishment for the Dayton region.

This partnership helps attract additional neurology specialists and provides improved access to neurological care in the Dayton area. It also enhances the ability of WSU’s researchers to attract federal grants and major clinical trials to the region.

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