Research

Clinical Trials

The Department of Neurology is actively involved in clinical trials to determine the effectiveness of new treatments for neurological conditions including epilepsy, multiple sclerosis, stroke and neuromuscular diseases and disorders. If you are interested in receiving additional information or participating in a trial, please e-mail or call the persons listed below. Please note that enrollment is currently closed for some of the trials.

IRB number	IRB18-1580
Title	The AMARANTH Clinical Trial Research Study
Site Principal Investigator	James Mastrianni, MD, PhD Clinical Trials Coordinator: Breanna Bertacchi, BA
Purpose	The University of Chicago Memory Center for Comprehensive Care and Research on Memory Disorders is currently enrolling individuals ages 55 to 85 years, with early Alzheimer’s disease (patients with mild cognitive impairment due to Alzheimer’s disease and patients diagnosed with mild dementia of the Alzheimer’s type) to participate in the clinical trial AMARANTH to help us examine an investigational drug that may have some effect on the brain changes associated with Alzheimer’s disease.
Eligibility	Be between 55 and 85 years old Have either: Experienced gradual and progressive change in memory function over more than 6 months (the study team will assess whether this is due to Alzheimer’s disease) OR Been diagnosed with mild Alzheimer’s disease or mild cognitive impairment (MCI) Have a relative, friend or caregiver who would be willing to be your study partner throughout the study.
Funding	APDM Wearable Technologies, Pfizer, Biogen
Duration	The study will last for approximately 24 months (about 8 weeks to see if you qualify, plus 2 years of treatment, then 4-6 weeks of follow-up).
Contact Name	Mildred Valentine
Phone/Email	mvalenti@neurology.bsd.uchicago.edu
Status Accrual	Active, recruiting

IRB number	IRB18-1580
Title	Imaging Dementia Evidence for Amyloid Scanning (IDEAS) Study Mild Cognitive Impairment (MCI)
Site Principal Investigator	James Mastrianni, MD, PhD Co-Principal Investigator: Daniel Applebaum, MD Clinical Trials Coordinator: Breanna Bertacchi,
Purpose	The purpose of the Imaging Dementia-Evidence for Amyloid Scanning (IDEAS) Study is to examine how brain imaging helps guide your doctor in how to treat your mild cognitive impairment, and whether these changes in your treatment plan lead to better health outcomes. A one-time brain imaging, called the amyloid PET (positron emission tomography) scan, will be requested by your doctor as part of your standard of care. The amyloid PET brain imaging will look at the build-up of amyloid plaques in the brain which has been linked with Alzheimer’s disease and other related diseases. The brain imaging is not being performed as part of the research; the actual part of the research study is to examine whether the imaging guides your medical treatment and improves health outcomes.
Eligibility	Be 65 years or older Be a Medicare beneficiary Have a diagnosis of mild cognitive impairment (MCI) or dementia (will be determined by The Memory Center) and have Alzheimer’s disease as a diagnostic consideration Meet additional study criteria Medicare will pay for your amyloid PET imaging exam as a covered benefit.
Funding	Alzheimer’s Association in collaboration with the American College of Radiology, and the American College of Radiology Imaging Network (ACRIN).
Contact Name	Mildred Valentine
Phone/Email	mvalenti@neurology.bsd.uchicago.edu
Status Accrual	Soon to be open for enrollment

IRB number	IRB16-1570
Title	Natural History of Genetic Modifiers in Spinocerebellar Ataxias
Site Principal Investigator	Christopher Gomez, MD, PhD
Purpose	The purpose of this study is to develop a cohort of individuals with SCA to learn more about the disease, find out how it progresses over time, and what may be the best way to measure progression.
Eligibility	SCA 1, 2, 3, 6, 7, 8, or 10 diagnosis
Funding	National Ataxia Foundation (NAF)
Visits	Yearly for up to 5 years
Contact Name	Hannah Casey
Phone/Email	773-832-4610 / hannahcasey@uchicago.edu
Status Accrual	Active, recruiting

IRB number	CIRB18-0570
Title	Clinical Trial Readiness for SCA 1 and SCA3
Site Principal Investigator	Christopher Gomez, MD, PhD
Purpose	The purpose of this study is to create the largest cohort of participants with the genetic mutation but have no ataxia symptoms or who have early-stage SCA 1 or SCA 3 and to collect data necessary for future clinical trials.
Eligibility	confirmed SCA 1, 3 diagnosis; at-risk for SCA 1 or SCA 3
Funding	NIH PAR-16-020
Visits	Yearly for up to 5 years
Contact Name	Hannah Casey
Phone/Email	773-832-4610 / hannahcasey@uchicago.edu
Status Accrual	Active, recruiting

IRB number	IRB18-1580
Title	Instrumented Data Exchange for Ataxia
Site Principal Investigator	Christopher Gomez, MD, PhD
Purpose	The purpose of this study is to learn how to better measure progression of SCA 1, 2, 3, 6, and FA.
Eligibility	SCA 1, 2, 3, 6, or FA diagnosis or healthy control
Funding	APDM Wearable Technologies, Pfizer, Biogen
Visits	Every 6 months for 2 years
Contact Name	Hannah Casey
Phone/Email	773-832-4610 / hannahcasey@uchicago.edu
Status Accrual	Active, recruiting

IRB number	IRB16-1547
Title	A Phase IIb/III, Randomized, Double-blind, Placebo-controlled Trial of BHV-4157 in Adult Subjects with Spinocerebellar Ataxia
Site Principal Investigator	Christopher Gomez, MD, PhD
Purpose	To compare the efficacy of BHV-4157 vs. placebo on ataxia symptoms in subjects with SCS after 8 weeks of treatment as measured by the total score on the SARA scale.
Funding	Biohaven Pharmaceuticals
Contact Name	Cindy Jimenez
Phone/Email	(773) 702-1848 / Email: cindyj@uchicago.edu
Status Accrual	Active, Not recruiting

IRB number	IRB18-1753
Title	A Phase III, Long-Term, Randomized, Double-blind, Placebo-controlled Trial of BHV-4157 in Adult Subjects with Spinocerebellar Ataxia
Site Principal Investigator	Christopher Gomez, MD, PhD
Purpose	To compare the efficacy of troriluzole versus placebo on ataxia symptoms I subjects with SCA Type 1 and Type 2, after 48 weeks of treatment as measured by the total score on the Modified F-SARA
Funding	Biohaven Pharmaceuticals
Contact Name	Cindy Jimenez
Phone/Email	(773) 702-1848 / Email: cindyj@uchicago.edu
Status Accrual	Active, Not recruiting

IRB number
Title	Monthly infusion of a drug that may repair MS lesions, added on to current therapy
Site Principal Investigator	P.I., Anthony Reder; with Adil Javed, BGW Arnason, and Veronica Penyak Cipriani
Purpose	AbbVie: Elezanumab in Relapsing MS (anti-Repulsive Guidance Molecule). [M18-918: A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Assess the Safety and Efficacy of Elezanumab when Added to Standard of Care in Relapsing Forms of Multiple Sclerosis]. Diagnosis of relapsing remitting or relapsing progressive multiple sclerosis for at least 2 years, with documented evidence of exacerbation in past 2 years, but not in past 6 months An EDSS score of 2.0-6.5, slowed walking, or arm dysfunction Able to perform and complete all protocol visits and procedures Untreated for 6-12 months, or on MS therapies such as glatiramer acetate (Copaxone®, others), teriflunomide (Aubagio®), fingolimod (Gilenya®), dimethyl fumarate (Tecfidera®), or ocrelizumab (Ocrevus®) with no dose changes for at least 6 months. But, no treatment with any of the following medications or procedures within the 6 months: Natalizumab, Cyclosporine, Azathioprine, Methotrexate, Mycophenolate mofetil, Intravenous immunoglobulin (IVIg, any interferon or IV, oral, or intrathecal corticosteroids. No treatment within 1 year with: cyclophosphamide, rituximab, or alemtuzumab. No treatment ever with cladribine or mitoxantrone.
Duration	1 year
Eligibility	18 -55 y/o, male or non-pregnant female, BMI 18 to 45
Funding
Contact Name	Mildred Valentine
Phone/Email	773.702.9812 / mvalenti@neurology.bsd.uchicago.edu
Status Accrual	Active, recruiting

MS Exacerbations

IRB number

Title

Mallinckrodt: Effects of ACTHAR on MRI and immunity during MS relapses with ACTH injections for treatment of MS exacerbations, followed by monitoring

Site Principal Investigator

PI: Adil Javed. Co-PI: X Feng. Sub-I’s: Anthony T Reder, T Carrol, Veronica P Cipriani

Purpose

This study is to test whether plasma or CSF CoQ10 could be a biomarker on patients with MSA

Diagnosis of acute MS attack with documented evidence new active MRI lesion

An EDSS score of 0-8

Able to perform and complete all protocol visits and procedures

No recent medium-dose or high-dose steroids such as prednisone or methylprednisolone

Eligibility

8 or older, male or female

Duration

up to 2.5 years

Funding

Contact Name

Mildred Valentine

Phone/Email

773.702.9812 / mvalenti@neurology.bsd.uchicago.edu

Status Accrual

Active, recruiting

IRB number	20-2063
Title	VERISMO - AN OBSERVATIONAL STUDY OF OCRELIZUMAB-TREATED PATIENTS WITH MULTIPLE SCLEROSIS TO DETERMINE THE INCIDENCE AND MORTALITY RATES OF BREAST CANCER AND ALL MALIGNANCIES
Site Principal Investigator	Dr. Anthony Reder
Purpose	To assess and characterize the incidence and mortality rates of breast cancer, all malignancies, and the long term safety regarding serious adverse events among patients with multiple sclerosis newly exposed to Ocrelizumab and other approved multiple sclerosis DMT under routine clinical care.
Eligibility	Ages 18 and older with MS New start with Ocrelizumab (grace period of 30 days before baseline/study entry) OR New starts with any of the Orals and Tysabri (Natalizumab) only Cladribine (Mavenclad), Alemtuzumab (Lemtrada), Dimethyl fumarate (Tecfidera), Fingolimod (Gilenya), Teriflunomide (Aubagio)
Funding	Externally funded – Roche Translational Clinical Research Center
Duration	May 2021 with possibility of extending, follow for 5 years
Contact Name/CRC	Sravya Aluri
Phone/Email	773.834.4654/ saluri@neurology.bsd.uchicago.edu
Status Accrual	Approved and recruiting

IRB number	20-0690
Title	CHIMES - An open label, multi-center study to assess disease activity and biomarkers of neuronal damage in minority patients with relapsing Multiple Sclerosis receiving treatment with Ocrelizumab
Site Principal Investigator	Dr. Veronica Penyak Cirpriani
Purpose	The purpose of the study is to see how Ocrelizumab impacts, good or bad on relapsing multiple sclerosis (RMS) in self-identified Blacks/African Americans with multiple sclerosis and in Hispanic/Latino Americans with multiple sclerosis. It will also look at the way Ocrelizumab may change certain biomarkers related to RMS in the body. Optional CSF substudy:
Eligibility	Ages 18 to 65 with RMS EDSS 0 to 5.5 inclusive (if EDSS>5, disease duration must be <15years) Self-identify as African American/Black/Latino American Treatment naïve or initiating 1st or 2nd switch from the following DMT: IFN-β-1a (Avonex, Rebif)/ IFN-β-1b (Betaseron/Betaferon)/ Peg-Interferon Beta-1a (Plegridy); Glatiramer acetate (Copaxone) At least 1-month washout period from last dose to screening, return of total WBC counts/ total lymphocyte count for following: Fingolimod (Gilenya), Siponimod (Mayzent), Ozanimod (Zeposia), Dimethyl fumarate (Tecfidera), Diroximel fumarate (Vumerity), Teriflunomide (Aubagio), Natalizumab (Tysabri) 1 episode (naïve) or suboptimal response/tolerance to prior DMT (switches) in past year 2 relapses within 12 months of screening (not w/n 30 days prior) 1 T1 weighted Gd lesion in past year and/or 1 new or expanding T2 lesion Active SPMS: disability progression independent of relapse over the past 12 months & at least 1 relapse within previous 2 years or 1 T1 Gd lesion at screening if no relapses within previous 2 years Vaccinations more than 6 weeks prior to first dose of Ocre Childbearing women: agree to remain abstinent or use OCPs
Funding	Pharmaceutical company – Genentech, Inc
Duration	Recruiting till end of 2021
Contact Name/CRC	Sravya Aluri or Mildred Valentine
Phone/Email	773.834.4654/ saluri@neurology.bsd.uchicago.edu or 773.702.9812/ mvalenti@neurology.bsd.uchicago.edu
Status Accrual	Approved and recruiting

IRB number	21-0031
Title	CONSONANCE - An Open-Label, Single-Arm 4 year study to Evaluate Effectiveness and safety of Ocrelizumab Treatment in patients with Progressive Multiple Sclerosis.
Site Principal Investigator	Dr. Anthony Reder
Purpose	The purpose of the study is to see if Ocrelizumab will halt the worsening of the signs and symptoms of Progressive forms of MS. This drug will be used for off-labels purposes in Progressive forms of MS. Optional sub study of MRI scan and its specifications -ensure that the MRI scanners and procedures for the handling and sending of medical image data are standardized to be able to compare MRI results from the hospitals/clinics that are participating in this study Optional sub study of optical coherence tomography (OCT) to evaluate the site's ability to conduct the procedure and allow for confirmation of the possibility of conducting OCT scans during an upcoming additional research study
Eligibility	Ages 18 to 65 with PMS, SPMS or PPMS EDSS ≤6.5 (if EDSS ≤5.0, disease duration must be ≤10 years and if EDSS >5.0, disease duration must be ≤15years) Evidence of disability progression independent of relapse activity in the last 2 years: fulfil at least 1 of the 21 criteria Experience using a smartphone and connecting it to Wi-Fi Childbearing women: agree to remain abstinent or use OCPs
Funding	Pharmaceutical Company Grant with funding – Genentech, Inc
Duration
Contact Name/CRC	Sravya Aluri or Mildred Valentine
Phone/Email	773.834.4654/ saluri@neurology.bsd.uchicago.edu or 773.702.9812/ mvalenti@neurology.bsd.uchicago.edu
Status Accrual	Approved and recruiting

IRB Number: CIRB19-0228

Study Title: Brain Oxygen Optimization in Severe TBI Phase-3

Site Principal Investigator: Christos Lazaridis, David Beiser

Purpose of Study: RCT of Brain tissue oxygen monitoring + ICP vs. ICP alone in

Study Eligibility: severe TBI

Funding source: NIH/NINDS/SIREN network

Contact Name (CRC): main contact Karli Molignoni

Phone/email Lazaridis@uchicago.edu

Status (Open/recruiting, on hold, etc.) Site Readiness Preparation

IRB number
Title	A Double-Blind, Randomized, Multicenter, Placebo Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Fingolimod 0.5 mg Administered Orally Once Daily Versus Placebo in Patients with Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
Site Principal Investigator	Kourosh Rezania MD
Purpose	The study is designed to evaluate the efficacy and safety of fingolimod in the treatment of CIDP compared with placebo.
Eligibility	Diagnosis of typical CIDP Disability defined by an INCAT Disability Scale score of 1-9 Receiving IVIg treatment (minimal dose equivalent to 0.4 g/kg every 4 weeks for a minimum of 12 weeks) Male or female, aged 18 years or older Patients should not have diabetes Patients with multifocal motor neuropathy or IgM paraproteinemia cannot be included
Funding	Novartis
Contact Name	Elizabeth Londo
Phone/Email
Status Accrual	Active, Recruiting

IRB number	CIRB15-1357
Title	EAY131: Molecular Analysis for Therapy Choice (MATCH)
Site Principal Investigator	Daniel Catenacci
Purpose	Details
Eligibility	Are you part of the research staff and cannot see your study listed here? Please contact the cancer center IT Team .

IRB number	IRB15-1476
Title	The Clinical Relevance of Margins in Frameless Stereotactic Radiosurgery for Intact Brain Metastases: a Randomized Trial of 0 vs 2 mm Margins
Site Principal Investigator	Steven Chmura
Purpose	Details
Eligibility	Are you part of the research staff and cannot see your study listed here? Please contact the cancer center IT Team .

IRB number	IRB16-0767
Title	A Phase I Study of Safety and Tolerability of Acetazolamide with Temozolomide in Adults with Newly Diagnosed or Recurrent Malignant Glioma
Site Principal Investigator	Bakhtiar Yamini
Purpose	Details
Eligibility	Are you part of the research staff and cannot see your study listed here? Please contact the cancer center IT Team .

Movement Disorder/Parkinson's Disease Program

IRB Number:	IRB20-0134
Study Title:	A Randomized, Double-Blind, Double-Dummy, Active-Controlled Study Comparing the Efficacy, Safety and Tolerability of ABBV-951 to Oral Carbidopa/Levodopa in Advanced Parkinson's Disease Patients
Site Principal Investigator:	Tao Xie, MD, PhD
Purpose:	To demonstrate the superiority of continuous 24-hour/day infusion of ABBV-951 over oral Carbidopa (CD)/Levodopa (LD) immediate release (IR) tablets in the treatment of advanced Parkinson’s disease and to gather information on the safety and tolerability of ABBV-951 after 12 weeks.
Eligibility:	Men and women 30 years of age or older with a diagnosis of levodopa-responsive idiopathic PD whose motor symptoms are poorly controlled by their current treatment
Funding:	AbbVie
Contact Name:	Tomas Mercado
Phone/Email:	773-702-4392 / tmercado@bsd.uchicago.edu
Length of Study:	13 visits (15 weeks)
Status Accrual:	Active, recruiting to begin mid-September 2020

IRB Number:	IRB19-1298
Study Title:	Registry for the Advancement of DBS in Parkinson’s Disease (RAD-PD)
Site Principal Investigator:	Tao Xie, MD, PhD
Purpose:	To create a registry of Parkinson’s disease patients who undergo deep brain stimulation (DBS) and follow each patient for a period of 5 years after surgery. OUR DBS (Outcomes and Unanswered Questions Registry in DBS) is a part of RAD-PD that entails collection of patient-reported outcomes and perspectives for the registry and allows patients to monitor their progress.
Eligibility:	Men and women diagnosed with idiopathic Parkinson’s disease; candidate for DBS treatment of PD as determined by the site investigator
Funding:	Michael J. Fox Foundation
Contact Name:	Tomas Mercado
Phone/Email:	773-702-4392/tmercado@bsd.uchicago.edu
Length of Study:	8 visits (5 years)
Status Accrual:	Active, recruiting to begin mid-September 2020

IRB Number:	IRB20-1261
Study Title:	Parkinson Disease Genetics in the African American Population
Site Principal Investigator:	Tao Xie, MD, PhD
Purpose:	To learn more about the genetic causes of Parkinson disease in the African American population
Eligibility:	Men and women 18 years of age or older with a diagnosis of Parkinson disease or atypical parkinsonism or healthy controls
Funding:	Michael J. Fox Foundation
Contact Name:	Tomas Mercado
Phone/Email:	773-702-4392/tmercado@bsd.uchicago.edu
Length of Study:	1 visit
Status Accrual:	Active, recruiting to begin mid-September 2020

IRB Number:	CIRB20-1093
Study Title:	TOPAZ Study, Trial of Parkinson's and Zoledronic Acid A Randomized Placebo-controlled Trial of Zoledronic Acid for Prevention of Fractures in Patients with Parkinson’s Disease
Site Principal Investigator:	Tao Xie, MD, PhD
Purpose:	To learn if a medicine called zoledronic acid can reduce fractures in people with Parkinson's Disease and/or parkinsonism
Eligibility:	Men and women 65 years of age or older with a diagnosis of Parkinson’s disease or neurodegenerative parkinsonism (including progressive supranuclear palsy, multiple system atrophy, cortical basal degeneration, vascular parkinsonism, dementia with Lewy bodies or another form of neurodegenerative parkinsonism); not confined to bed or wheelchair
Funding:	National Institutes of Health, National Institute on Aging (NIH/NIA)
Contact Name:	Tomas Mercado
Phone/Email:	773-702-4392/tmercado@bsd.uchicago.edu
Length of Study:	16 visits (5 years)
Status Accrual:	Active, recruiting to begin mid-September 2020

IRB number	IRB17-0998
Title	Characteristics of African American people with Parkinson’s disease: A hospital based study at the University of Chicago of the African American community in Chicago’s south side.
Site Principal Investigator	Tao Xie, MD PhD
Purpose	This study is looking for subjects with PD of African American or Caucasian background to study the clinical features and genetic profile of African American patients with PD.
Eligibility	PD patients
Funding	Parkinson’s Foundation
Contact Name	Tomas Mercado
Phone/Email	773-702-4392 / tmercado@bsd.uchicago.edu
Status Accrual	Active, recruiting

Stroke Program

IRB Number	CIRB19-0779
Study Title	Arcadia (AtRial Cardiopathy and Antithrombotic Drugs In prevention After cryptogenic stroke)
Site Principal Investigator	James Brorson, MD
Purpose of Study	To test apixaban versus aspirin in preventing new strokes in patients with embolic stroke of undetermined stroke (ESUS) and evidence with atrial cadiopathy
Study Eligibility	Age ≥ 45; clinical diagonsis of ischemic stroke; Modified Rankin Score ≤ 4; ability to be randomized within 3 to 180 days after stroke, ESUS (embolic stroke of undetermined source)
Funding source	National Institutes of Health
Contact Name (CRC)	Vikrant Chauhan
Phone/email	773-702-8186, vchauhan2@neurology.bsd.uchicago.edu
length of study (# of visits)	At least 540 days (8 visits + a visit every 180 days until end of study period)
Status (Open/recruting, on hold, etc.)	Recruiting

IRB Number	CIRB19-1517
Study Title	ASPIRE (Anticoagulation in Intracerebral Hemorrhage (ICH) Survivors for Stroke Prevention and Recovery)
Site Principal Investigator	Scott Mendelson, MD PhD
Purpose of Study	To compare the effects of apixaban and aspirin to prevent new strokes and death in patients with a recent, first-ever Intracerebral hemorrhage and non-valvular atrial fibrillation.
Study Eligibility	Age ≥ 18 years; Qualifying intracerebral hemorrhage (ICH) within 14-120 days of enrollment; Non-valvular atrial fibrillation; CHA₂DS₂-VASc score ≥ 2
Funding source	National Institutes of Health
Contact Name (CRC)	Vikrant Chauhan
Phone/email	773-702-8186, vchauhan2@neurology.bsd.uchicago.edu
length of study (# of visits)	36 months or less (2 baseline visits +visits once every 90 days until 36 months is reached or study closeout)
Status (Open/recruting, on hold, etc.)	Preparing- high priority

IRB Number	CIRB16-0854
Study Title	Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial
Site Principal Investigator	James Brorson, MD
Purpose of Study	The purpose of this trial is to determine the best way to prevent strokes in people who have a high amount of blockage of their carotid artery but no stroke symptoms related to that blockage.
Study Eligibility	Age ≥ 35 years old; Carotid stenosis; No medical history of stroke or transient ischemic attack; Modified Rankin Score of 0 or 1; Women must not be of childbearing potential or if of childbearing potential have a negative pregnancy test
Funding source	Mayo Hospitals and Clinics
Contact Name (CRC): main contact	James Brorson, MD
Phone/email	773-702-7215, jbrorson@neurology.bsd.uchicago.edu
Length of study (# of visits)	4 years (12 visits)
Status (Open/recruting, on hold, etc.)	Recruiting

IRB Number	CIRB20-1232
Study Title	Determinants of Incident Stroke Cognitive Outcomes and Vascular Effects on Recovery (DISCOVERY)
Site Principal Investigator	Shyam Prabhakaran, MD, MS, FAHA, FANA
Purpose of Study	DISCOVERY will become a landmark study to unravel the mechanisms of post-stroke cognitive disability, early stroke recovery, and potential targets for personalized prevention, intervention and rehabilitation.
Study Eligibility	Age ≥ 18 years; Admitted to the hospital with a diagnosis of AIS, ICH, or aSAH; Radiographic confirmatory evidence of: (1) AIS, (2) non-traumatic ICH or (3) non-traumatic acute aSAH; able to be enrolled within 6 weeks of stroke onset
Funding source	Massachusetts General Hospital
Contact Name (CRC): main contact	Mariel Dronson
phone/email	773-702-0235, m.dronson@neurology.bsd.uchicago.edu
length of study (# of visits)	24-48 months (7 visits + annual phone follow-up for those enrolled within first two years of study)
Status (Open/recruting, on hold, etc.)	Under Review

IRB Number	IRB19-0539
Study Title	ENHANCING STROKE PREHOSPITAL AND EMERGENCY EVALUATION (ESPEED)
Site Principal Investigator	Shyam Prabhakaran, MD, MS, FAHA, FANA
Purpose of Study	The purpose of the study is to address two important gaps in knowledge about the acute evaluation and treatment of stroke patient: prehospital screening errors and delays in inter-hospital transfer. In doing so, the study will produce generalizable knowledge that can be widely applied to other urban regions of the country and provide preliminary data and demonstration of novel approaches that could be evaluated in large-scale comparative effectiveness studies across multiple regions.
Participants	NA (no participants)
Funding source	Agency for Healthcare Research and Quality
Contact Name (CRC): main contact	Zahra Parnianpour
Phone/email	773-702-5425, zparnianpour@neurology.bsd.uchicago.edu
Length of study (# of visits)	Funding through 4/30/22
Status (Open/recruting, on hold, etc.)	Active

IRB Number	CIRB20-1205
Study Title	rFVIIa for Acute Hemorrhagic Stroke Administered at Earliest Time (FASTEST) Trial
Site Principal Investigator	Christopher Kramer, MD
Purpose of Study	To test the hypothesis that treatment with rFVIIA within two hours of onset in appropriately selected patients with spontaneous ICH improves outcome as measured by the ordinal distribution of the modified Rankin Scale (mRS) at 180 days, as compared to placebo
Study Eligibility	Patients aged 18-80 years; Patients with spontaneous ICH, Able to treat with study medication (rFVIIa/placebo) within 120 minutes of stroke onset or last known well; Efforts to obtain informed consent per EFIC guidelines
Funding source	National Institutes of Health
Contact Name (CRC): main contact	Vikrant Chauhan
Phone/email	773-702-8186,vchauhan2@neurology.bsd.uchicago.edu
Length of study (# of visits)	180 days (4 visits inpatient during hospital admission + 3 follow-up visits)
Status (Open/recruting, on hold, etc.)	Under Review

IRB Number	IRB20-0649
Study Title	Hemostasis, hematoma expansion, and outcomes after intracranial hemorrhage
Site Principal Investigator	Fernando Goldenberg, MD, FNCS
Purpose of Study	Determine the hemostatic mechanisms of hematoma expansion after intracerebral hemorrhage, leading to specific interventions that can improve patient outcomes after intracerebral hemorrhage and other bleeding conditions (e.g., neurotrauma, subdural hematoma).
Study Eligibility	Age ≥ 21; Patients presenting with spontaneous intracranial hemorrhage within 12 hours of symptom onsent
Funding source	Northwestern University
Contact Name (CRC): main contact	Elida Romo
Phone/email	eromo1@neurology.bsd.uchicago.edu
Length of study (# of visits)	3 months (2 visits during hospital admission + 1 follow-up at 3 months)
Status (Open/recruting, on hold, etc.)	Under Review

IRB Number	CIRB19-0678
Study Title	Multi-arm Optimization of Stroke Thrombolysis (MOST): a single blinded, randomized controlled adaptive, multi-arm, adjunctive-thrombolysis efficacy trial in ischemic stroke.
Site Principal Investigator	Christopher Kramer, MD
Purpose of Study	The primary efficacy objective of the MOST trial is to determine if argatroban or eptifibatide results in improved 90-day modified Rankin scores (mRS) as compared with placebo in acute ischemic stroke (AIS) patients treated with 0.9mg/kg IV rt-PA within three hours of symptom onset.
Study Eligibility	Acute ischemic stroke patients; Treated with IV rt-PA within 3 hours of stroke onset; Age ≥ 18; NIHSS score ≥ 6 prior to IV rt-PA; Able to receive assigned study drug within 60 minutes but no later than 75 minutes of initiation of IV rt-PA
Funding source	National Institutes of Health
Contact Name (CRC): main contact	Vikrant Chauhan
Phone/email	Vikrant Chauhan, vchauhan2@neurology.bsd.uchicago.edu
Length of study (# of visits)	90 days (5 visits during hospital admission + 2 follow-up visits)
Status (Open/recruting, on hold, etc.)	Recruiting

IRB Number	IRB20-0500
Study Title	Neuro-AFib Study - Retrospective Phase (Phase I)
Site Principal Investigator	Scott Mendelson, MD, PhD
Purpose of Study	The data collected for this study will mprove understanding of markers of stroke risk in nonvalvular atrial fibrillation (NVAF) patients, improve understanding of stroke mechanisms in NVAF, and provide data for the establishment of large scale RCTs investigating the best stroke prevention treatments in patients with NVAF at high risk for stroke.
Study Eligibility	Patients will be identified from "Get With the Guidelines- Stroke" database: Age ≥ 18; Admitted for an ischemic or hemorrhagic stroke to a participating institution between January 1, 2018 and December 31, 2019; Diagnosed with NVAF either before or during this admission using an EKG, telemetry, or any type of external or implantable cardiac rhythm monitor
Funding source	Massachusetts General Hospital
Contact Name (CRC): main contact	Mariel Dronson
Phone/email	773-702-0235, m.dronson@neurology.bsd.uchicago.edu
Length of study (# of visits)	NA: data abstraction only
Status (Open/recruting, on hold, etc.)	Under Review

IRB Number	IRB19-1213
Study Title	Targeted Healthcare Engineering for Stroke
Site Principal Investigator	Shyam Prabhakaran, MD, MS, FAHA, FANA and Jane L. Holl, MD, MPH
Purpose of Study	The goal of THESIS is to understand the underlying causes of acute stroke diagnostic error and apply user-centered design principles to develop a feasible and sustainable intervention. By reducing the “upstream” barrier of diagnostic error in stroke,more accurate and timely diagnosis of acute stroke will be achieved and patients will be more likely to receive prompt and accurate treatment, which will result in reduced mortality and disability,and improved health outcomes after a stroke.
Study Eligibility	Stroke stakeholders: Neurology MDs and RNs, ED MDs and RNs, Radiology MDs and techs, stroke coordinators, and stroke patients and caregivers
Funding source	Agency for Healthcare Research and Quality (AHRQ)
Contact Name (CRC): main contact	Elida Romo
Phone/email	eromo1@neurology.bsd.uchicago.edu
Length of study (# of visits)	4 years: 10/1/2019 and 09/30/2023
Status (Open/recruting, on hold, etc.)	Recruiting

IRB Number	IRB19-1100
Study Title	Relatives' Experience of Organ Donation Requests From Brain-Dead Patients (PHASE 1)
Site Principal Investigator	Fernando Goldenberg, MD, FNCS
Purpose of Study	The purpose of this study is to explore family and/or surrogate decision-makers' perceptions regarding organ donation after brain death, including their experiences with communication with the treatment team and organ procurement organization.
Study Eligibility	NA
Funding source	Gift of Hope Organ and Tissue Network
Contact Name (CRC): main contact	Zahra Parnianpour
Phone/email	773-702-5425, zparnianpour@neurology.bsd.uchicago.edu
Length of study (# of visits)	1 telephone interview, 2 brief standardized questionnaires, and follow-up call/email
Status (Open/recruting, on hold, etc.)	Active

Movement Disorders/Parkinson's Disease Program:

Active, Not Recruiting

IRB Number:	IRB19-0751
Study Title:	Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of BHV-3241 in Subjects with Multiple System Atrophy (M-STAR Study)
Site Principal Investigator:	Tao Xie, MD, PhD
Purpose:	To test the effectiveness, safety, and tolerability of an investigational drug called BHV-3241, also known as verdiperstat, compared to placebo in patients with Multiple System Atrophy (MSA)
Eligibility:	Men and women 40-80 years old with a diagnosis of probable or possible MSA, including either MSA subtype, MSA-Parkinsonism (MSA-P) or MSA-Cerebellar (MSA-C); must be able to walk at least 10 steps without the assistance of another person but use of assistive devices (e.g. walker or cane) is allowed; BMI less than or equal to 40; must have reliable caregiver
Funding:	Biohaven Pharmaceuticals
Contact Name:	Tomas Mercado
Phone/Email:	773-702.4392 / tmercado@neurology.bsd.uchicago.edu
Length of Study:	9 visits (1 year)
Status Accrual:	Active, no longer recruiting

IRB Number:	IRB19-0751
Study Title:	Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of BHV-3241 in Subjects with Multiple System Atrophy (M-STAR Study)
Site Principal Investigator:	Tao Xie, MD, PhD
Purpose:	To test the effectiveness, safety, and tolerability of an investigational drug called BHV-3241, also known as verdiperstat, compared to placebo in patients with Multiple System Atrophy (MSA)
Eligibility:	Men and women 40-80 years old with a diagnosis of probable or possible MSA, including either MSA subtype, MSA-Parkinsonism (MSA-P) or MSA-Cerebellar (MSA-C); must be able to walk at least 10 steps without the assistance of another person but use of assistive devices (e.g. walker or cane) is allowed; BMI less than or equal to 40; must have reliable caregiver
Funding:	Biohaven Pharmaceuticals
Contact Name:	Tomas Mercado
Phone/Email:	773-702.4392 / tmercado@neurology.bsd.uchicago.edu
Length of Study:	9 visits (1 year)
Status Accrual:	Active, no longer recruiting

RB Number
Title	Neuroimaging biomarkers in parkinsonism: differentiating subtypes and tracking disease progression.
Site Principal Investigator	Tao Xie, MD PhD
Purpose	To study the biomarkers in brain MRI imaging in PD, PSP and MSA.
Eligibility	Typical PD, MSA and PSP patients
Funding	NINDS/NIH
Contact Name	Tomas Mercado
Phone/Email	773-702.4392 / tmercado@neurology.bsd.uchicago.edu
Status Accrual	Active, Not recruiting

IRB number	IRB17-1681
Title	A study on plasma and CSF CoQ10 as a biomarker on patients with multiple system atrophy (MSA).
Site Principal Investigator	Tao Xie, MD PhD and Mahesh Padmanaban, MD
Purpose	This study is to test whether plasma or CSF CoQ10 could be a biomarker on patients with MSA
Eligibility	Typical PD, MSA and PSP patients
Funding	Private donation
Contact Name	Tomas Mercado
Phone/Email	773-702.4392 / tmercado@neurology.bsd.uchicago.edu
Status Accrual	Active, recruiting

IRB number: IRB17-0531

Title: Caffeine and other possible biomarkers in Parkinson’s disease

Site Principal Investigator: Tao Xie, MD PhD

Purpose: This study to test whether plasma or urine caffeine or its metabolites could be a biomarker of PD patients

Eligibility: Newly diagnosed PD patients not on any anti-PD medications

Funding: Michael J Fox Foundation

Contact Name: Tomas Mercado

Phone/Email: 773-702.4392 / tmercado@neurology.bsd.uchicago.edu

Status Accrual: Active, Not recruiting

Multiple Sclerosis Program

Genentech: CHORDS study, Ocrelizumab switch from failed disease-modifying drugs in RRMS. P.I., Anthony Reder; with Adil Javed, BGW Arnason, and Veronica Penyak Cipriani. Completely Enrolled.

MedDay: Effect of MD1003 (high-dose biotin) in progressive multiple sclerosis: a randomized double-blind placebo controlled study. P.I., Anthony Reder; with Adil Javed, BGW Arnason, and Veronica Penyak Cipriani. Completely Enrolled.

Biogen: AFFINITY trial, BIIB003 (Anti-LINGO) added to other MS therapies in Progressive MS. P.I., Anthony Reder; with Adil Javed, BGW Arnason, and Veronica Penyak Cipriani. Completely Enrolled.

Genentech: MN39159 CONSONANCE trial, An Open-Label, Single-Arm, 4-Year Study To Evaluate Effectiveness And Safety Of Ocrelizumab in Progressive MS. P.I., Anthony Reder; with Adil Javed, BGW Arnason, and Veronica Penyak Cipriani. Completely Enrolled.

NMO Program

Chugai: Phase I trial of an anti-IL-6 MAb in neuromyelitis optica (NMO). P.I., Adil Javed; with AT Reder, BGW Arnason, and VP Cipriani. Completely Enrolled.

MedImmune: Phase I trial of an anti-CD19 MAb in neuromyelitis optica (NMO). P.I., Adil Javed; with AT Reder, BGW Arnason, and VP Cipriani. Completely Enrolled.

IRB Number: IRB16-0559

Title: A multicenter, open-label, long-term treatment study of intravenously administered BIIB092 in patients with progressive supranuclear palsy (PSP) who participated in study CN002003 (CN002004)

Site Principal Investigator: Tao Xie, MD PhD

Purpose: This study is to test a new drug to treat PSP. We will collect demographic, clinical information, samples of blood and CSF, and MRI images

Eligibility: PSP patients between 41-86 years, have completed the CN002003 study, must have a reliable caregiver.

Funding: Biogen

Status Accrual: Closed

IRB Number: IRB17-1545

Title: An extension study of ABBV-8E12 in progressive supranuclear palsy (M15-563)

Site Principal Investigator: Tao Xie, MD PhD

Purpose: This study is to test a new drug to treat PSP. We will collect clinical information, demographics, samples of blood and CSF, and MRI images.

Eligibility: PSP patients between 45-85 years, with PSP symptoms for no more than 5 years, must be able to ambulate 5 steps independently, must have completed AbbVie M15-562 trial.

Funding: Abbvie

Status Accrual: Closed

IRB number: IRB17-0446

Title: A randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of intravenously administered BIIB092 in participants with progressive supranuclear palsy (CN002012)

Site Principal Investigator: Tao Xie, MD PhD

Purpose: This study is to test a new drug to treat PSP. We will collect clinical information, demographics, samples of blood and CSF, and MRI images.

Eligibility: PSP patients between 45-85 years, with PSP symptoms for no more than 5 years, must be able to ambulate 10 steps independently

Funding: Biogen

Status Accrual: Closed