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Clinical Trials

Scientists at the medical school are conducting hundreds of clinical trials daily. Learn more about all our work via the Feinberg Office of Research Clinical Trials page.

Our current active protocols are listed below, searchable by disease or condition. If you have any questions about the particular study protocol, please contact the study coordinator.  For more information about the research or participation in general, please call 312-695-8643.

Trials

Peripheral Neuropathy Research Registry (PNRR)

National Peripheral Neuropathy Research Registry (PNRR), a collection of different types ofinformation, such as patient medical, family, and social histories and blood samples. Theinformation is carefully maintained so that it can be studied repeatedly in the future. The registryaims to help researchers’ access large amounts of information about people with …
National Peripheral Neuropathy Research Registry (PNRR), a collection of different types ofinformation, such as patient medical, family, and social histories and blood samples. Theinformation is carefully maintained so that it can be studied repeatedly in the future. The registryaims to help researchers’ access large amounts of information about people with PN. By using thisregistry, researchers will facilitate both basic and clinical research studies that will bring improvedunderstandings of the etiology (origination) and pathogenesis (development) of PN. They willspecifically ask why some patients with peripheral neuropathy develop neuropathic pain and othersdo not, and what the characteristics of patients with painful peripheral neuropathy are in terms oftheir symptoms, examination findings, and blood tests. Ultimately this research may result inimproved diagnosis, more effective treatments, and possibly prevention.
Inclusion criteria: 1. Diabetic Peripheral Neuropathy 2. Chemo-therapy Induced Peripheral Neuropathy 3. HIV-induced Peripheral Neuropathy 4. Idiopathic Peripheral Neuropathy; Exclusion criteria: Any other type of Peripheral Neuropathy
Ajroud-Driss, SendaAjroud-Driss, Senda
  • Map it 675 N. St. Clair St. Suite 20 100
    Chicago, IL
STU00048864
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NUDB 13C03: Northwestern Brain Tumor Institute Research Database

The Northwestern Brain Tumor Institute (NBTI) currently uses an electronic database to collect and store information about patients who come to the NBTI for evaluations, including diagnosis, treatment, follow-up, and/or to obtain additional opinions. This database is called the Northwestern Brain Tumor Institute Database or NBTIDB, and it …

The Northwestern Brain Tumor Institute (NBTI) currently uses an electronic database to collect and store information about patients who come to the NBTI for evaluations, including diagnosis, treatment, follow-up, and/or to obtain additional opinions. This database is called the Northwestern Brain Tumor Institute Database or NBTIDB, and it was developed to replace older paper methods for collecting and storing information.

The purpose of this study is to allow researchers involved with the NBTIDB to use data stored in it for future research studies and projects. The NBTIDB also allows researchers to track whether or not patients have agreed to allow their information to be linked to their leftover tissue samples, which are kept in the hospital’s pathology department, for future research studies.

You may be eligible to take part in the research component of the NBTIDB if you are either a new or returning patient, over the age of 18, who is being seen by one of the clinicians at the NBTI and are or will be entered into the NBTIDB, or a patient who is not coming to the NBTI for evaluation, but would still like to participate in the NBTIDB.

Kumthekar, Priya UKumthekar, Priya U
  • Map it 201 E. Huron St.
    Chicago, IL
STU00087359
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Movement Disorders Biorepository

This is a registry aimed to collect biologic and clinical information, such as blood and tissue samples, and family and medical histories from patients diagnosed with a movement disorder. The purpose of studying materials from the registry is to identify factors that either cause these neurologic conditions or increase one’…
This is a registry aimed to collect biologic and clinical information, such as blood and tissue samples, and family and medical histories from patients diagnosed with a movement disorder. The purpose of studying materials from the registry is to identify factors that either cause these neurologic conditions or increase one’s risk for developing them. Samples collected for this biorepository include a blood sample (or a saliva sample) and a skin biopsy. Participants may choose to donate one or both samples.

• Diagnosis of a movement disorder • Male or female 18 years of age or older when diagnosed • Ability to provide informed consent

Akhtar, Rizwan SmeerAkhtar, Rizwan Smeer
  • Map it 259 E. Erie St. Lavin Pavillion, Suite 19 100
    Chicago, IL
STU00091585
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Evaluating the Circadian Response to Light in Delayed Sleep-Wake Phase Disorder

This study is looking at factors that contribute to the timing of sleep. Interested subjects will undergo screening to determine their sleep-wake habits, then will have an eye test and a blood draw. Participation will involve 2 outpatient visits, separated by up to 3 weeks of sleep-wake activity …
This study is looking at factors that contribute to the timing of sleep. Interested subjects will undergo screening to determine their sleep-wake habits, then will have an eye test and a blood draw. Participation will involve 2 outpatient visits, separated by up to 3 weeks of sleep-wake activity monitoring.
Individuals with delayed sleep-wake phase disorder and healthy controls
Abbott, Sabra MargaretAbbott, Sabra Margaret
  • Map it 201 E. Huron St.
    Chicago, IL
STU00203647
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A wearable myoelectric-computer interface to reduce muscle co-activation in acute and chronic stroke

We are conducting a study investigating the use of small wearable devices, called myoelectric computer interfaces, to reduce abnormal arm muscle coordination in individuals with impaired arm movement from a stroke. Training will take place predominantly at home, with some sessions in the lab as well. This study could potentially …
We are conducting a study investigating the use of small wearable devices, called myoelectric computer interfaces, to reduce abnormal arm muscle coordination in individuals with impaired arm movement from a stroke. Training will take place predominantly at home, with some sessions in the lab as well. This study could potentially lead to improved arm function for stroke survivors who have abnormal arm coordination.

At least 18 years of age

- Had a stroke more than 6 months ago

- No large impairment in vision (glasses), memory, language or concentration

- Not currently participating in another research study on the arm

Slutzky, Marc WSlutzky, Marc W
  • Map it 355 E. Erie St.
    Chicago, IL
  • Map it 320 E. Superior Ave. Searle 11
    Chicago, IL
  • Map it 201 E. Huron St.
    Chicago, IL
STU00203644
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Enroll-HD: A Prospective Registry Study in a Global Huntington’s Disease Cohort

The purpose of this research study is to collect clinical information about patients and their health. We will also collect biological samples, such as blood and DNA (the genetic material in your blood). Researchers will use this information and samples to learn more about HD and to try to find …
The purpose of this research study is to collect clinical information about patients and their health. We will also collect biological samples, such as blood and DNA (the genetic material in your blood). Researchers will use this information and samples to learn more about HD and to try to find new treatments for the disease. People from many countries contribute to Enroll-HD.
Individuals 18 yrs or older affected by Huntington's Disease (HD) or from a HD family or are a "community control" (a person who does not carry the HD genetic mutation that causes Huntington's disease and is not part of an HD family, but would like to participate in the study). Research visits are conducted yearly and will consists of a collection of medical and family history and biological samples.
Bega, DannyBega, Danny
  • Map it 675 N. St. Clair St. Suite 20 100
    Chicago, IL
STU00203021
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The Role of Circadian Dysfunction in Hepatic Encephalopathy in Patients with Cirrhosis

Individuals with advanced liver disease (cirrhosis) often report new or worsening sleep problems. 
1) Diagnosis of end-stage liver disease or cirrhosis; 2) being evaluated for liver transplant; 3) Age >=18yo; 4) no severe kidney disease (for example, patients currently on dialysis are not eligible)
Kim, MinjeeKim, Minjee
  • Map it 201 E. Huron St.
    Chicago, IL
STU00204423
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Clinical Research Consortium for the Study of Cerebellar Ataxia (CRC-SCA) to Study Natural History and Genetic Modifiers in Spinocerebellar Ataxia (SCA)

The purpose of this study is to collect natural history data among ataxia patients in a cohort of SCA 1, 2, 3, 6 patients using clinic-based neurological rating scales and performance measures. Another study goal is to identify new measures of ataxia, cognition, and neurobehavior in comparison to traditional …
The purpose of this study is to collect natural history data among ataxia patients in a cohort of SCA 1, 2, 3, 6 patients using clinic-based neurological rating scales and performance measures. Another study goal is to identify new measures of ataxia, cognition, and neurobehavior in comparison to traditional clinician rating methods. The gene analysis is expected to establish a relationship, if any, between age at onset of disease and disease progression rates.
• Age 18 and older
• Presence of symptoms and signs of ataxia
• Molecular diagnosis of SCA 1, 2, 3, 6 either in the participant or an affected family member
• Willingness to participate in the study and ability to give informed consent.
Opal, PuneetOpal, Puneet
  • Map it 259 E. Erie St. Lavin Pavillion, Suite 19 100
    Chicago, IL
NCT01060371 STU00204294
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Genetic causes and pathogenic mechanisms of adult epilepsies

The purpose of this study is to look at genetic markers of epilepsy in patients and their families using blood, saliva, skin, and brain tissue analysis.
Gerard, Elizabeth ErwayGerard, Elizabeth Erway
STU00205877
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Clinical Trial Readiness for SCA1 and SCA3

Subjects must be 18-65 years of age with symptoms of ataxia or a diagnosis of SCA1 or SCA3 or have an affected family member. Subjects with a previous diagnosis of early stage SCA1 or SCA 3 may also be eligible. Subject must be able to undergo a MRI (brain …
Subjects must be 18-65 years of age with symptoms of ataxia or a diagnosis of SCA1 or SCA3 or have an affected family member. Subjects with a previous diagnosis of early stage SCA1 or SCA 3 may also be eligible. Subject must be able to undergo a MRI (brain scan) and not weigh over 300 lbs.
Subjects aged 18 to 65 with presence of symptomatic ataxic disease or asymptomatic mutation carrier or subjects with definite molecular diagnosis of SCA1 or SCA3 or another affected family member or Subjects of age >18 with previous diagnosis of early stage SCA1 and SCA3. Subjects must not make changes in physical/occupational therapy status within two months prior to enrollment. Subjects must not weigh over 300 lbs.
5) 6) No changes in sical/occupational therapy status within two months prior to enrolment
Opal, PuneetOpal, Puneet
  • Map it 259 E. Erie St. Lavin Pavillion, Suite 19 100
    Chicago, IL
NCT03487367 STU00206988
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Gut Microbial remodeling with Resistant Maltodextrin for motor and non-motor symptoms in Parkinson's disease: safety and tolerability study.

The objective of this study is to examine thesafety and tolerability of resistant maltodextrin (RM), a prebioticnon-digestible fiber, and its effect on the gut microbiome, as well as motor and non-motorsymptoms, in Parkinson's Disease.We will conduct a randomized, parallel-groupdouble-blinded controlled trial assessing resistant maltodextrin …
The objective of this study is to examine thesafety and tolerability of resistant maltodextrin (RM), a prebioticnon-digestible fiber, and its effect on the gut microbiome, as well as motor and non-motorsymptoms, in Parkinson's Disease.

We will conduct a randomized, parallel-groupdouble-blinded controlled trial assessing resistant maltodextrin to placebo. You will be randomized (like a coin flip) toreceive either resistant maltodextrin or maltodextrin to take once a day in themorning for 4 weeks.

Participation in this research study lasts 6-7 weeks and includes 3 in-person visits and 4 phone assessments.

You may be eligible if you:

  • are ≥ 60 years
  • have been diagnosed with Parkinson's Disease
  • have NOT been diagnosed with diabetes
  • are not currently taking any probiotics or laxatives
  • Malkani, Roneil GopalMalkani, Roneil Gopal
    NCT03667404 STU00207142
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    The Impact of Low Flow Nocturnal Oxygen Therapy on Hospital Admissions and Mortality in Patients with Heart Failure and Central Sleep Apnea.

    The purpose of this trial is to evaluate the long-term effects of Nocturnal Oxygen Therapy (NOXT) on the mortality and morbidity of patients with stable heart failure and a reduced ejection fraction (HFrEF), already receiving optimal guideline-directed medical therapy (GDMT), who have central sleep apnea (CSA).…
    The purpose of this trial is to evaluate the long-term effects of Nocturnal Oxygen Therapy (NOXT) on the mortality and morbidity of patients with stable heart failure and a reduced ejection fraction (HFrEF), already receiving optimal guideline-directed medical therapy (GDMT), who have central sleep apnea (CSA).

    Inclusion Criteria:

    • Aged ≥ 21 years at the date of consent.
    • History of chronic, stable heart failure with reduced ejection fraction with left ventricular ejection fraction (LVEF) ≤ 45% determined by echocardiography, radionuclide angiography, left ventriculography, or cardiac magnetic resonance imaging, within the year prior to enrollment.
    • Central sleep apnea, defined using as an apnea-hypopnea index (AHI) > 15/h with ≥ 50% central events (apnea and hypopneas) and a central AHI ≥ 10/h or obstructive apnea index (OAI) < 20%
    • New York Heart Association (NYHA) Class III or IV, or NYHA Class II with ≥ 1 hospitalization for HF in the last 24 months.
    • Treatment with stable, optimized guideline-directed medical therapies (GDMT) according to applicable guidelines in the U.S. and Canada, where stable is defined as the addition of no new class of disease-modifying drug for ≥ 30 days prior to randomization.
    • In the investigator's opinion, willing and able to comply with all study requirements
    • Able to fully understand study information and sign an Institutional Review Board (IRB) approved informed consent

    Exclusion Criteria:

    • Current positive airway pressure use of diagnosis of Obstructive Sleep Apnea (OSA).
    • Oxygen saturation < 90% at rest during the day.
    • Oxygen saturation < 88% for > 5 continuous minutes during sleep unaccompanied by respiratory events.
    • Chronic daytime or nighttime use of supplemental oxygen.
    • Current smoker or bed partner that smokes in the bedroom.
    • Severe pulmonary disease requiring continuous home oxygen therapy or the continuous or frequent intermittent use of oral steroids or documented severe chronic obstructive pulmonary disease (COPD) with forced expiratory volume in 1 second (FEV1) < 50%.
    • Body mass index (BMI) > 35 kg/m2.
    • Cardiac surgery, percutaneous coronary intervention, myocardial infarction or unstable angina within the previous 3 months.
    • Transient ischemic attack or stroke within the previous 3 months.
    • Cardiac resynchronization therapy implantation scheduled or performed within 3 months prior to randomization.
    • Primary hemodynamically-significant uncorrected valvular heart disease (obstructive or regurgitant) or any valvular disease expected to require surgery during the trial
    • Acute myocarditis/pericarditis or other cause of potentially reversible cardiomyopathy (e.g., post-partum cardiomyopathy, tachycardia-induced cardiomyopathy), within the previous 6 months.
    • End-stage (Stage D) heart failure (HF) requiring continuous outpatient intravenous (IV) inotropic therapy, placement of ventricular assist device, listing for cardiac transplantation, or end-of-life care (e.g. hospice care).
    • Pregnancy or of child bearing potential without a negative pregnancy test within 10 days prior to enrollment.
    • Life expectancy < 1 year for diseases unrelated to chronic HF.
    • Enrolled or planning to enroll in another study that may conflict with protocol requirements or confound subject results in this trial.
    Zee, Phyllis CZee, Phyllis C
    • Map it 676 N. Saint Clair St. Seventh Floor, Suite 701
      Chicago, IL
    • Map it 259 E. Erie St. Lavin Pavillion, Suite 19 100
      Chicago, IL
    NCT03745898 STU00209337
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    Natural history study of ALS and other motor neuron disorders

    This is one of the largest non-interventional observational study of patients with ALS and other motor neuron disorders. It is both prospective and retrospective. It does not require blood sampling.

    1. A clinical diagnosis of El Escorial of suspected, possible, probable, or definite ALS.

    2. Other motor neuron disorders, including but not limited to spinobulbar muscular atrophy (SBMA, Kennedy’s disease), Spinal Muscular Atrophy (SMA), Primary Lateral Sclerosis (PLS), Progressive Muscular Atrophy (PMA), and Progressive Bulbar Palsy (PBP).

    3. Excluded are any disease that does not meet criteria for any motor neuron disorder

    Ajroud-Driss, SendaAjroud-Driss, Senda
    • Map it 259 E. Erie St. Lavin Pavillion, Suite 19 100
      Chicago, IL
    STU00209860
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    Parkinson’s Foundation Genetic Research Initiative

    The main objective of this study is to assess the feasibility, impact, and participant satisfaction of offering Clinical Laboratory Improvement Amendments (CLIA) certified genetic testing as part of their clinical care for People with Parkinson’s disease (PWP).…

    The main objective of this study is to assess the feasibility, impact, and participant satisfaction of offering Clinical Laboratory Improvement Amendments (CLIA) certified genetic testing as part of their clinical care for People with Parkinson’s disease (PWP).

    • Must have an official diagnosis of Parkinson's disease
    • Willingness to undergo genetic testing, and choose to be informed of genetic testing results for GBA, LRRK2 and 5 additional PD related
    genes (SNCA, VPS35, PRKN, PINK-1, PARK7).
    • Must have necessary technology (computer with camera, or tablet) including internet access to complete telemedicine visit (if
    selected).

    Simuni, TatyanaSimuni, Tatyana
    • Map it 259 E. Erie St. Lavin Pavillion, Suite 19 100
      Chicago, IL
    NCT03924414 STU00210600
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    MultiStem® Administration for Stroke Treatment and Enhanced Recovery Study (MASTERS-2) (Protocol #: B01-04)

    A Phase 3 study to examine the safety and effectiveness of the allogeneic, adult stem cell investigational product, MultiStem®, in adults who have suffered an acute ischemic stroke in the previous 18-36 hours.…
    A Phase 3 study to examine the safety and effectiveness of the allogeneic, adult stem cell investigational product, MultiStem®, in adults who have suffered an acute ischemic stroke in the previous 18-36 hours.

    Primary Inclusion Criteria:

    • Male or female subjects ≥18 years of age
    • Clinical diagnosis of ischemic stroke involving cerebral cortex
    • Onset of stroke symptoms must have occurred 18 to 36 hours prior to the planned start of administration of the investigational product
    • Occurrence of a moderate to moderately severe stroke with a persistent neurologic deficit documented by a NIHSS score of 8 to 20 (inclusive) that does not change by ≥4 points during the initial screening period
    • A mRS score of 0 or 1 prior to the onset of symptoms of the current stroke

    Primary Exclusion Criteria:

    • Presence of a lacunar or a brainstem infarct
    • Comatose state
    • Brain hemorrhage
    • Major neurological event such as stroke or clinically significant head trauma within 6 months of enrollment into the study

    Batra, AyushBatra, Ayush
    • Map it 201 E. Huron St.
      Chicago, IL
    • Map it 259 E. Erie St. Lavin Pavillion, Suite 19 100
      Chicago, IL
    NCT03545607 STU00209969
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    A Phase 1 Single- and Multiple-Ascending-Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of BIIB094 Administered Intrathecally to Adults With Parkinson’s Disease (Protocol# 254PD101)

    The purpose of study is to determine whether BIIB094 may improve PD symptoms in subjects with or without changes in the LRRK2 gene. The study medication will be given as an injection into your back near the spinal cord. This iscalled an “intrathecal” injection.…
    The purpose of study is to determine whether BIIB094 may improve PD symptoms in subjects with or without changes in the LRRK2 gene. The study medication will be given as an injection into your back near the spinal cord. This iscalled an “intrathecal” injection.

    2. Diagnosis of PD w/in 7yrs without motor fluctuationsor dyskinesia.

    3. Not on any medication for PD or on stable therapy for 8weeks prior to screening.

    Larson, Danielle NicoleLarson, Danielle Nicole
    • Map it 259 E. Erie St. Lavin Pavillion, Suite 19 100
      Chicago, IL
    NCT03976349 STU00210196
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    Study in Parkinson Disease of Exercise Phase 3 Clinical Trial: SPARX3

    This study is a Phase 3 multi-site, randomized, evaluator-masked, study of endurance treadmill exercise on changes in the MDS-UPDRS Part III score at 12 months. Subjects will be randomly assigned to 2 endurance exercise groups: 1) moderate intensity exercise: 60-65% HRmax or 2) high intensity exercise: …

    This study is a Phase 3 multi-site, randomized, evaluator-masked, study of endurance treadmill exercise on changes in the MDS-UPDRS Part III score at 12 months. Subjects will be randomly assigned to 2 endurance exercise groups: 1) moderate intensity exercise: 60-65% HRmax or 2) high intensity exercise: 80-85% HRmax. The endurance exercise will be 4 days per week for approximately 30 minutes per session for 18 months.

    -Diagnosis of Parkinson's disease for less than 3 years

    -Cannot be treated with any PD medication

    Poon, CynthiaPoon, Cynthia
    NCT04284436 STU00211903
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    Oxidative Markers and Efficacy in ALS/MND Phenotypes Treated with Edaravone (Loma Linda)

    We are only recruiting patients who have not started their edaravone treatment.Location of study: Les Turner ALS Center at Northwestern Medicine, 259 E. Erie St., Lavin 19, Chicago, IL 60611.…

    We are only recruiting patients who have not started their edaravone treatment.

    Location of study: Les Turner ALS Center at Northwestern Medicine, 259 E. Erie St., Lavin 19, Chicago, IL 60611.

    Inclusion:

    Either possible, probable, or definite ALS,predominantly lower motor neuron disease Predominantly upper motor neuron disease, orbulbar

    With or without cognitive involvement

    Willing to participate

    On no experimental treatment

    Ages 18 - 85

    No prior exposure to Radicava

    On a stable dose of riluzole for 30 days or offriluzole

    Male or female

    Females of childbearing age must usecontraception

    Exclusion:

    Unstable medical illness

    Abnormal liver function (>2x ULN)

    Unlikely to survive for at least 26 weeks

    Ajroud-Driss, SendaAjroud-Driss, Senda
    • Map it 259 E. Erie St. Lavin Pavillion, Suite 19 100
      Chicago, IL
    NCT04097158 STU00211350
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    A Phase 1/2a Open-Label Ascending Dose Study to Evaluate the Safety and Effects of LY3884961 in Patients with Parkinson’s Disease with at Least One GBA1 Mutation (PROPEL, Protocol #: J3Z-MC-OJAA previously called PRV-PD101)

    PR001A is an investigational gene therapy product that is being developed for the treatment of PD in patients with GBA1 mutations. The purpose of this study is to find out what effects PR001A has on Parkinson’s disease patients. Participants will be assigned to receive one dose of PR001A by …
    PR001A is an investigational gene therapy product that is being developed for the treatment of PD in patients with GBA1 mutations. The purpose of this study is to find out what effects PR001A has on Parkinson’s disease patients. Participants will be assigned to receive one dose of PR001A by injection into the cisterna magna (a large space at the base of the brain).

    1. 40-75 years of age.

    2. Diagnosis of PD with H&Y 3-4.

    3. On stable PD therapy for 8 weeks prior to baseline.

    4. At least 1 GBA gene mutation.

    Larson, Danielle NicoleLarson, Danielle Nicole
    • Map it 259 E. Erie St. Lavin Pavillion, Suite 19 100
      Chicago, IL
    NCT04127578 STU00209947
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    Platform Trial for the Treatment of Amyotrophic Lateral Sclerosis (ALS): A perpetual multi-center, multi-regimen clinical trial evaluating the safety and efficacy of investigational products for the treatment of ALS.

    In this trial, multiple investigational products for ALS will be tested simultaneously or sequentially. Each investigational product will be tested in a regimen. Each regimen consists of a placebo-controlled trial, meaning that the active investigational product and matching placebo will be tested in each regimen.The additional details that …

    In this trial, multiple investigational products for ALS will be tested simultaneously or sequentially. Each investigational product will be tested in a regimen. Each regimen consists of a placebo-controlled trial, meaning that the active investigational product and matching placebo will be tested in each regimen.

    The additional details that govern the testing of each investigational product will be summarized in separate regimen-specific appendices (RSAs). Each regimen will have a separate ClinicalTrials.gov posting, which will include specific information about the regimen. All regimen-specific outcome measures will be detailed in each regimen posting.

    Participants will have an equal chance to be randomized to all regimens that are active at the time of screening. Once randomized to a regimen, participants will be randomized in a 3:1 ratio to either study drug or placebo.

    The following regimens are active in the trial:

    Regimen A - Zilucoplan Regimen B - Verdiperstat Regimen C - CNM-Au8 Regimen D - Pridopidine Regimen E - Trehalose

    New regimens will be continuously added as new investigational products become available. The HEALEY ALS Platform Trial will enroll additional participants as each new regimen is available.

    The basic eligibility criteria include:

    1. Onset of ALS WEAKNESS within the last 3 years.

    2. FVC (breathing test) > 50%

    3. If on riluzole, must be on a stable dose for 30 days. Must not start riluzole during the study.

    4. If on radicava, must be on a stable dose for 30 days. Must not start riluzole during the study.

    5. Must be able to swallow for the next 6 months

    6. No history stem cell treatment

    7. No history of cancer within the last 5 years

    Ajroud-Driss, SendaAjroud-Driss, Senda
    • Map it 259 E. Erie St. Lavin Pavillion, Suite 19 100
      Chicago, IL
    NCT04297683 STU00212680
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    NP-SLE

    This study will examine different proteins and cell types in blood and cerebrospinal fluid (CSF) of patients with systemic lupus (SLE) who may or may not currently be experiencing neuropsychiatric manifestations of the disease. We aim to identify specific factors that affect the regulation of genes to help explain what …

    This study will examine different proteins and cell types in blood and cerebrospinal fluid (CSF) of patients with systemic lupus (SLE) who may or may not currently be experiencing neuropsychiatric manifestations of the disease. We aim to identify specific factors that affect the regulation of genes to help explain what goes wrong in systemic lupus. Then, we hope to develop treatments that will target these factors.

    Inclusion Criteria:

    • Meet 4 of 11 American College of Rheumatology (ACR) criteria for systemic lupus (SLE) or meet 3 of 11 ACR criteria for SLE and meet SLICC criteria
    • 18 years or older
    • Positive ANA or positive dsDNA

    Exclusion Criteria:

    • Currently pregnant or nursing
    • Active or chronic infections (such as hepatitis, pneumonia, pyelonephritis, HIV, sepsis)
    • Diagnosed with another chronic autoimmune disease or chronic neurodegenerative condition
    • CKD > 2 and/or GFR < 60
    • AST and/or ALT ≥ 3 times the upper limit of normal
    • Current electrolyte disturbance (hyponatremia or hypernatremia)
    • Current signs or symptoms of acute systemic vascultis
    Cuda, Carla MarieCuda, Carla Marie
    • Map it 675 N. Saint Clair St. Fourteenth Floor, Suite 100
      Chicago, IL
    STU00211615
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    The Parkinson’s Progression Markers Initiative (PPMI) 2.0 Clinical - Establishing a Deeply Phenotyped PD Cohort

    The purpose of this study is to obtaininformation from people with and without Parkinson disease (PD) so thatresearchers may better understand how Parkinson disease progresses, in order toinform better treatments. Participants will have a neurological examination, a brain scan, provide blood samples and complete some questionnaires.…
    The purpose of this study is to obtaininformation from people with and without Parkinson disease (PD) so thatresearchers may better understand how Parkinson disease progresses, in order toinform better treatments. Participants will have a neurological examination, a brain scan, provide blood samples and complete some questionnaires.
    Simuni, TatyanaSimuni, Tatyana
    • Map it 259 E. Erie St. Lavin Pavillion, Suite 19 100
      Chicago, IL
    STU00212785
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    COVID-19 and the impact on the Immune System

    This study will characterize immune responses specific to the virus that causes COVID-19 and how they contribute to favorable or poor outcomes. We hope to identify factors that predict the development of long COVID to improve medical care of COVID-19 and related complications. The visit itself will consist …

    This study will characterize immune responses specific to the virus that causes COVID-19 and how they contribute to favorable or poor outcomes. We hope to identify factors that predict the development of long COVID to improve medical care of COVID-19 and related complications. The visit itself will consist of reviewing and signing the consent form, a blood draw of approximately 2 tablespoons of blood, optional stool/nasal samples and a brief questionnaire to review demographics, medications, and medical conditions. You will receive a gift card of $20 for your participation and donation. Individual results generated from this study cannot be shared with the study participant.

    Age between 18 and 90 years old

    Have had a positive COVID test within the last two years

    Does not have any symptoms lasting more than 6 weeks post infection

    Koralnik, Igor JeromeKoralnik, Igor Jerome
    • Map it 420 E. Superior St.
      Chicago, IL
    STU00212583
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    Use of Glenohumeral Injections for Management of Shoulder Pain in Individuals with ALS

    The purpose of this study is to develop a practice for measuring the efficacy of ultrasound-guided shoulder joint injections in patients with ALS who have exhibited shoulder pain and/or adhesive capsulitis. Patients will receive corticosteroid injections as part of their normal or standard care for shoulder pain in …
    The purpose of this study is to develop a practice for measuring the efficacy of ultrasound-guided shoulder joint injections in patients with ALS who have exhibited shoulder pain and/or adhesive capsulitis. Patients will receive corticosteroid injections as part of their normal or standard care for shoulder pain in ALS (not provided by the study). They will then be asked to complete questionnaires at Baseline and over the phone over approximately 3 months. 
    1. Diagnosed with ALS

    2. Being referred for evaluation for glenohumeral shoulder injections for management of shoulder pain

    3. Able to utilize written, typed or verbal communication, independently or with the assistance of a caregiver

    4. Able to understand study procedures, answer questionnaires, and provide informed consent

    Franz, Colin KFranz, Colin K
    • Map it 259 E. Erie St. Lavin Pavillion, Suite 19 100
      Chicago, IL
    STU00213465
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    A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Arm, Multicenter Study Evaluating the Efficacy and Safety of Pridopidine in Patients with Early Stage of Huntington Disease

    The purpose of this study is to evaluate the safety and effectiveness of the study drug, pridopidine,on everyday functioning and daily activities, as well as movement and behaviorin participants with early stage Huntington Disease (HD)…
    The purpose of this study is to evaluate the safety and effectiveness of the study drug, pridopidine,on everyday functioning and daily activities, as well as movement and behaviorin participants with early stage Huntington Disease (HD)

    1. >25yrs of age.

    2. Diagnosis of HD with CAG repeat > 36

    Bega, DannyBega, Danny
    • Map it 259 E. Erie St. Lavin Pavillion, Suite 19 100
      Chicago, IL
    NCT04556656 STU00213780
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    A multicenter, double-blind, randomized study to evaluate the effects of tasimelteon vs. placebo in participants with Delayed Sleep-Wake Phase Disorder (DSWPD)

    The purpose of this study is to evaluate the effect of aninvestigational drug called tasimelteon on the sleep-wake cycle of patientswith Delayed Sleep-Wake Phase Disorder (DSWPD) and to assess the safety oftasimelteon. Participants in this study will randomly be assigned totasimelteon or placebo, to take over a period …

    The purpose of this study is to evaluate the effect of aninvestigational drug called tasimelteon on the sleep-wake cycle of patientswith Delayed Sleep-Wake Phase Disorder (DSWPD) and to assess the safety oftasimelteon. Participants in this study will randomly be assigned totasimelteon or placebo, to take over a period of 35 days. During this time,participants will be required to go to bed at certain fixed times and keep anelectronic daily sleep diary. Additionally, there will be 4 visits to yourstudy doctor's clinic, where you will be assessed for eligibility and safety.At the clinic, your study doctor will perform a physical examination, blooddraws, heart tests, questionnaires, and test your urine for drugs and alcohol.You will not be charged for any of these procedures and you may be compensatedfor your time.

    If you complete the initial 35 days of the study, you willhave the option of receiving treatment with tasimelteon for up to 11 monthsafter. No matter which treatment you were randomly assigned during the first 35days, tasimelteon or placebo, you will receive tasimelteon during theadditional 11 months, if you choose to continue. During those 11 months, therewill be 4 additional visits to your study doctor's clinic (spaced 60-90 daysapart) to assess your health and safety.

    • Inclusion Criteria:

      • Ability and acceptance to provide written informed consent of the participant or legal guardian. Participants ≥ 16 and < 18 years of age will also need to provide written assent.
      • A confirmed clinical diagnosis of Delayed Sleep-Wake Phase Disorder (DSWPD).
      • Men or women between 16 - 65 years, inclusive.
      • Body Mass Index (BMI) of ≥ 18 and ≤ 30 kg/m^2.

    • Exclusion Criteria:
      • History of psychiatric disorders within 12 months.
      • Major surgery, trauma, illness, general anesthesia, or immobility for 3 or more days within the last 30 days.
      • Pregnancy, recent pregnancy (within 6 weeks), or women who are breastfeeding.
      • A positive test for substances of abuse
    Zee, Phyllis CZee, Phyllis C
    • Map it 676 N. Saint Clair St. Seventh Floor, Suite 701
      Chicago, IL
    • Map it 259 E. Erie St. Lavin Pavillion, Suite 19 100
      Chicago, IL
    NCT04652882 STU00213922
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    A Double-Blind Placebo-Controlled, Randomized 18-Month Phase 2A Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinectics of Oral UCB0599 in Study Participants with Early Parkinson’s Disease

    This study is for people with early-stage Parkinson's disease. The objective of this study is to find out whether UCB0599, an investigational medication, can slow down the progression of PD. This study also tests whether UCB0599 is safe and tolerable. This study is placebo-controlled and will last …

    This study is for people with early-stage Parkinson's disease. The objective of this study is to find out whether UCB0599, an investigational medication, can slow down the progression of PD. This study also tests whether UCB0599 is safe and tolerable. This study is placebo-controlled and will last about 21 months. If you join the study, you will have regular scheduled appointments with the study staff and will have medical procedures and tests during these visits, like imaging studies, body function tests, and questionnaires.

    You might be a candidate for this study if:

    • You are 40 - 75 years old
    • You have been diagnosed with Parkinson disease within the last two years
    • You have only mild symptoms of PD, like slowness of movement, muscle stiffness / rigidity, or tremor / shaking

    There are additional eligibility criteria that will be discussed with you.

    Akhtar, Rizwan SmeerAkhtar, Rizwan Smeer
    • Map it 259 E. Erie St. Nineteenth Floor
      Chicago, IL
    NCT04658186 STU00214389
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    PLS Natural History Study (PNHS)

    This is a non-interventional (no study drug), natural history study of patient with primary lateral sclerosis (PLS). The purpose of this study is to to develop a natural history dataset and biorepository of early PLS and well-established PLS cases for future clinical trials. The study will also evaluate …

    This is a non-interventional (no study drug), natural history study of patient with primary lateral sclerosis (PLS).

    The purpose of this study is to to develop a natural history dataset and biorepository of early PLS and well-established PLS cases for future clinical trials. The study will also evaluate differences in disease progression in early PLS and well-established PLS cases.

    Patients will be enrolled over 24 months and complete assessments in person and over the phone.

    Some of the BASIC, but not full, list of eligibility criteria are below:

    1. PLS diagnosis is based on the new PLS diagnostic criteria

    2. Symptom onset was no more than 15 years prior to baseline

    3. Ability to independently walk with or without an assistive device (e.g., walker) at the baseline evaluation

    4. Some bulbar symptoms (dysarthria, dysphagia, drooling or pseudobulbar affect)

    5. UMN symptoms and signs in a region other than the legs

    Ajroud-Driss, SendaAjroud-Driss, Senda
    • Map it 259 E. Erie St. Lavin Pavillion, Suite 19 100
      Chicago, IL
    STU00214272
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    Web-based Automated Imaging Differentiation of Parkinsonism

    This study is for people who have Parkinson's disease (PD), multiple system atrophy (MSA), or progressive supranuclear palsy (PSP). The objective of this study is to find out whether an advanced imaging study can distinguish people with PD, MSA, or PSP from one another. The imaging study uses a …

    This study is for people who have Parkinson's disease (PD), multiple system atrophy (MSA), or progressive supranuclear palsy (PSP). The objective of this study is to find out whether an advanced imaging study can distinguish people with PD, MSA, or PSP from one another. The imaging study uses a brain MRI (without dye or contrast) along with a web-based automated software tool that analyzes the MRI data automatically. The study requires two visits, one at the start and one 12-18 months later. The MRI is only performed at the first visit. At each visit, there are assessments of movement and thinking, along with several questionnaires.

    • Age of 40 - 80 years
    • Ability to have a brain MRI scan
    • Clinical diagnosis of Parkinson disease at least 5 years ago, or
    • Clinical diagnosis of multiple systems atrophy (parkinsonian type), or
    • Clinical diagnosis of progressive supranuclear palsy
    Akhtar, Rizwan SmeerAkhtar, Rizwan Smeer
    • Map it 259 E. Erie St. Nineteenth Floor
      Chicago, IL
    STU00214779
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    A Phase 3 Randomized, Placebo-Controlled Trial With a Longitudinal Natural History Run-In and Open-Label Extension to Evaluate BIIB067 Initiated in Clinically Presymptomatic Adults With a Confirmed Superoxide Dismutase 1 Mutation

    Tofersen (also called BIIB067) is currently being evaluated for the treatment of adults with familial ALS associated with a mutation in the SOD1 gene. The optimal timing for initiation (i.e., prior to or after the emergence of clinically manifested disease) of tofersen is unknown. This study will evaluate the …

    Tofersen (also called BIIB067) is currently being evaluated for the treatment of adults with familial ALS associated with a mutation in the SOD1 gene. The optimal timing for initiation (i.e., prior to or after the emergence of clinically manifested disease) of tofersen is unknown. This study will evaluate the impact of initiating tofersen based on biomarker evidence of disease activity, prior to the emergence of clinical symptoms or signs that definitively indicate ALS.

    There are four parts to this study, each with different eligibility criteria. Please contact the study coordinator and he/she will determine whether you are eligible. In order to enroll in the study (Part A), here are a few basic (but not complete) eligibility criteria:

    1. 18 years or older

    2. Must have one of the following SOD1 mutations confirmed by a central reader. Please contact the study coordinator for a complete list.

    3. If a SOD1 mutation is not listed, your mutation will be adjudicated by a Mutation Adjudication Committee.

    4. Plasma neurofilament (NfL) level less than 44 pg/mL during Screening

    5. Clinically pre-symptomatic for ALS (i.e., must not have clinically manifested ALS) at Part A Screening Visit

    6. History or positive test result at Screening for HIV, Hep-B, or Hep-C

    Ajroud-Driss, SendaAjroud-Driss, Senda
    • Map it 259 E. Erie St. Lavin Pavillion, Suite 19 100
      Chicago, IL
    NCT04856982 STU00214617
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    A PHASE IIB, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF INTRAVENOUS PRASINEZUMAB IN PARTICIPANTS WITH EARLY PARKINSON'S DISEASE

    This is a multicenter, randomized, double-blind, placebo-controlled study that will evaluate the efficacy and safety of intravenous (IV) prasinezumab versus placebo in participants with Early Parkinson's Disease (PD) who are on stable symptomatic PD medication.…
    This is a multicenter, randomized, double-blind, placebo-controlled study that will evaluate the efficacy and safety of intravenous (IV) prasinezumab versus placebo in participants with Early Parkinson's Disease (PD) who are on stable symptomatic PD medication.

    • Diagnosis of PD for at least 6 months to maximum 3 years at screening and between 50-85 years of age

    • On symptomatic PD medication for at least 6 months, with a stable dose for 3 months prior to baseline

    • No dyskinesisa or motor fluctuations (i.e. MDS-UPDRS Part IV = 0)

    Larson, Danielle NicoleLarson, Danielle Nicole
    NCT04777331 STU00214429
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    Multi-center, Noninterventional Study Evaluating Variability, Reliability, and Compliance for the Parkinson’s Disease Diary

    The primary objective of the study is to assess the impact of the frequency of assessments on the variability over time, reliability, and compliance for the PD diary in patients with PD in whom medications do not provide adequate control of symptoms.…

    The primary objective of the study is to assess the impact of the frequency of assessments on the variability over time, reliability, and compliance for the PD diary in patients with PD in whom medications do not provide adequate control of symptoms.

    1.≥39 to ≤70 years of age at signing of informed consent

    2. Diagnosis of clinically established PD

    3. Marked levodopa responsiveness at screening per investigator’s judgment

    4. A minimum of 3 years and a maximum of 18 years from time of PD diagnosis to the date of screening

    5. Receiving optimized and stable PD medical therapy for ≥1 month prior to screening or demonstrated intolerance to PD medications per investigator’s judgment in agreement with the medical monitor

    6. ≥3 hours of average daily OFF-time assessed within 3 months of screening by PD diary or per investigator’s judgment

    Shetty, Neil KantaShetty, Neil Kanta
    • Map it 259 E. Erie St. Lavin Pavillion, Suite 19 100
      Chicago, IL
    STU00217962
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    Efficacy, Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of BIA 28-6156 in GBA-PD

    The purpose of this study is to assess the efficacy of BIA 28-6156 over placebo in delaying clinical meaningful motor progression over 78 weeks in subjects with Parkinson's disease who have a pathogenic variant in the glucocerebrosidase 1 (GBA1) gene (GBA-PD).…

    The purpose of this study is to assess the efficacy of BIA 28-6156 over placebo in delaying clinical meaningful motor progression over 78 weeks in subjects with Parkinson's disease who have a pathogenic variant in the glucocerebrosidase 1 (GBA1) gene (GBA-PD).

    - The subject is ≥35 and ≤80 years of age at the time of informed consent.

    - The subject has a clinical diagnosis of PD for at least 1 year and for no longer than

    7 years before initiation of screening

    - The subject has a modified Hoehn and Yahr score ≤2.5.

    - The subject is receiving symptomatic treatment for PD.

    - The subject has a known GBA-PD risk-associated variant

    Larson, Danielle NicoleLarson, Danielle Nicole
    • Map it 259 E. Erie St. Lavin Pavillion, Suite 19 100
      Chicago, IL
    NCT05819359 STU00218849
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