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

Breanna Bertacchi

Phone/Email

773-834-1688 / bbertacchi1@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

Breanna Bertacchi

Phone/Email

773-834-1688 / bbertacchi1@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: 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:

Lani Leong

Phone/Email:

773-834-1688 / lani@neurology.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:

Lani Leong

Phone/Email:

773-834-1688 / lani@neurology.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:

Lani Leong

Phone/Email:

773-834-1688 / lani@neurology.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:

Lani Leong

Phone/Email:

773-834-1688 / lani@neurology.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

Lani Long

Phone/Email

773-834-1688 / lani@neurology.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:

Lani Leong

Phone/Email:

773-834-1688 / lani@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:

Lani Leong

Phone/Email:

773-834-1688 / lani@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

Lani Long

Phone/Email

773-834-1688 / lani@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

Lani Long

Phone/Email

773-834-1688 / lani@neurology.bsd.uchicago.edu

Status Accrual

Active, recruiting

IRB number:  IRB17-0531                  

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

Site Principal InvestigatorTao 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:  Breanna Bertacchi

Phone/Email:  773-834-1688 / bbertacchi1@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