Clinical Trials in Treatment of Neurological Disorders
Dignity Health Neurological Institute is proud to be a part of multiple multi-center, national and international clinical research trials. As a comprehensive stroke center, it is of the utmost importance to bring the latest advancements to patients. Clinical trials provide an opportunity to improve stroke care, increase quality of life, and decrease mortality. Through continued participation in these clinical trials, Dignity Health Neurological Institute is helping to discover new preventive care and new treatments for Stroke, Multiple Sclerosis, Epilepsy and Headache to improve overall quality of life for patients.
Stroke
ACTION 2:
This is a Phase 2, multicenter, double-blind, placebo-controlled, randomized, 3-arm, dose ranging study. Eligible patients will present with supratentorial acute ischemic stroke and will be randomized to receive intravenous natalizumab 600 mg, natalizumab 300 mg, or placebo as a single treatment within 9 to 24 hours of last known normal. The main purpose of this trial is to look at the clinical effects of natalizumab versus placebo in acute ischemic stroke on clinical measures of independence and activities of daily living. The target is a score of 0 or 1 on the mRS at the 90 day follow up.
Sponsor: Biogen MA Inc.
Principal investigator: Lucian Maidan, MD
Clinical Trials Website: ClinicalTrials.gov
BASE:
This is a multi-site prospective study that will enroll patients who present to the Emergency Department (ED) or hospital with suspected acute ischemic stroke or transient ischemic attack within 18 to 30 hours of last known normal. Patients will have 3 blood draws (at/around admission, after 24 hours, and after 48 hours or discharge – whichever comes first). The purpose of this study is to validate the clinical use of new biomarker tests (ISCDX and TIADX) to evaluate blood components that may differentiate between different stroke category types. These include:
- Acute ischemic stroke (AIS) versus transient ischemic attack (TIA) versus transient neurological events (TNE).
- Cardio-embolic versus large artery atherosclerotic strokes when bleed has been ruled out.
- Cardio-embolic strokes caused by A-fib versus those not caused by A-fib.
Sponsor: Ischemia Care, LLC
Principal investigator: Lucian Maidan, MD
Clinical Trials Website: ClinicalTrials.gov
Sponsor Website: Ischemia Care, LCC
MISTIE-III:
This is a phase III, randomized, open-label, 500-subject clinical trial of minimally invasive surgery plus rt-PA in the treatment of intracerebral hemorrhage. Eligible patients will present with spontaneous supratentorial intracranial hemorrhage ≥ 30 mL with a Glasgow Coma Scale (GCS) ≤ 14 or NIHSS ≥ 6. Patients will be randomized to minimally invasive surgery (placement of catheter into clot, treatment with rt-PA every 8 hours with drainage until clot volume ≤ 10 mL) or medical management. The main purpose is to show that treatment with minimally invasive surgery plus rt-PA is safe and improves functional outcomes over standard of care (medical management). Each patient is followed for 12 months.
Sponsor: The National Institute of Neurological Disorders and Stroke (NINDS)
Study Intervention Provided by: Genentech, Inc.
Principal investigator: Alex Nee, MD
Clinical Trials Website: ClinicalTrials.gov
SMART:
A prospective, multicenter registry of patients treated in accordance with the cleared indications for Smart, Penumbra Coil 400™ (PC 400), and Penumbra Occlusion Device (POD®). Eligible patients will present with intracranial aneurysm or other vascular malformation with the plan to treat with the Penumbra Smart Coil System. Data for each patient are collected in accordance with the standard of care at each participating hospital through the one-year follow-up. The main purpose of this registry is to gather post market data on the Penumbra SMART COIL® System (Smart System) in the treatment of intracranial aneurysms and other malformations.
Sponsor: Penumbra, Inc.
Principal investigator: Lucian Maidan, MD
Clinical Trials Website: ClinicalTrials.gov
Multiple Sclerosis
CHORDS:
This open label study evaluates the effectiveness and safety of Ocrelizumab in patients with relapsing-remitting multiple sclerosis who have had suboptimal course with other disease modifying treatments.
Principal investigator: Sabeen Lulu, MD
Clinical Trials Website: ClinicalTrials.gov
Expanded Access Ocrelizumab:
This is an open label expanded access program for Ocrelizumab in patients with primary progressive multiple sclerosis.
Principal investigator: John Schafer, MD
Clinical Trials Website: ClinicalTrials.gov
Ofatumumab:
This randomized, double-blind study compares the experimental drug ofatumumab with currently available Teriflunomide in patients with relapsing-remitting multiple sclerosis.
Principal investigator: Sabeen Lulu, MD
Epilepsy
ARTEMIS ARTEMIS:
A randomized, double-blind, placebo-controlled study of the safety and efficacy of intranasal midazolam in the outpatient treatment of subjects with seizure clusters.
Principal investigator: Edwin Cruz, MD
Headache
EVIDERA:
This is a prospective observational study to evaluate the tolerability and outcomes of prophylactic therapies in migraine headaches.
Principal investigator: Alan Shatzel, DO
