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.
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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. Eligibility CriteriaInclusion 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 Location(s)
IRB number STU00048864 Keywords Peripheral Neuropathy; Registry; Copy Study URL to Clipboard Copy |
NUDB 13C03: Northwestern Brain Tumor Institute Research DatabaseThe 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. Eligibility Criteria 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. Location(s)
IRB number STU00087359 Copy Study URL to Clipboard Copy |
Movement Disorders BiorepositoryThis 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. Copy Study URL to Clipboard Copy |
A wearable myoelectric-computer interface to reduce muscle co-activation in acute and chronic strokeWe 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. Eligibility Criteria 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 Location(s) IRB number STU00203644 Keywords stroke rehabilitation muscle control Copy Study URL to Clipboard Copy |
Enroll-HD: A Prospective Registry Study in a Global Huntington’s Disease CohortThe 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. Eligibility CriteriaIndividuals 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. Location(s)
IRB number STU00203021 Copy Study URL to Clipboard Copy |
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. Eligibility Criteria• 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. Location(s)
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Natural history study of ALS and other motor neuron disordersThis 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. Eligibility Criteria 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 Location(s)
IRB number STU00209860 Copy Study URL to Clipboard Copy |
Study in Parkinson Disease of Exercise Phase 3 Clinical Trial: SPARX3This 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. Eligibility Criteria -Diagnosis of Parkinson's disease for less than 3 years -Cannot be treated with any PD medication Copy Study URL to Clipboard Copy |
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. Eligibility Criteria 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 Location(s)
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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). Eligibility Criteria 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. Location(s)
Keywords Parkinson's disease Copy Study URL to Clipboard Copy |
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. Eligibility Criteria 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 Location(s)
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NP-SLEThis 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. Eligibility Criteria Inclusion Criteria:
Exclusion Criteria:
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IRB number STU00211615 Copy Study URL to Clipboard Copy |
The Parkinson’s Progression Markers Initiative (PPMI) 2.0 Clinical - Establishing a Deeply Phenotyped PD CohortThe 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. Copy Study URL to Clipboard Copy |
COVID-19 and the impact on the Immune SystemThis 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. Copy Study URL to Clipboard Copy |
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. Eligibility Criteria Some of the BASIC, but not full, list of eligibility criteria are below: 1. PLS diagnosis is based on the new PLS diagnostic criteria2. 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 Location(s)
IRB number STU00214272 Copy Study URL to Clipboard Copy |
A Phase 3 Clinical Study of UX701 AAV-mediated Gene Therapy for the Treatment of Wilson DiseaseThe purpose of this research study is to assess if an investigational product (study drug), called UX701, is an effective and safe treatment for adults aged 18 years or older with Wilson disease. Eligibility Criteria 1.Individuals ≥ 18 years of age at the time of informed consent. 2. Confirmed diagnosis of Wilson disease. 3. Stable Wilson Disease with no medication or dose changes for at least 6 months at Screening. 4. Ongoing restriction of high copper containing foods for at least 6 months at Screening and continued through study participation. Copy Study URL to Clipboard Copy |
Web-based Automated Imaging Differentiation of ParkinsonismThis 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. Eligibility Criteria
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IRB number STU00214779 Copy Study URL to Clipboard Copy |
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 MutationTofersen (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. Eligibility CriteriaThere 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 Location(s)
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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 DISEASEThis 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. Eligibility Criteria • 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) Copy Study URL to Clipboard Copy |
A novel measurement concept to objectively quantify severity of vocal and speech related symptoms associated with Parkinson’s Disease.The purpose of this study is to determine whether smartphone app-based digital speech assessments can provide speech data that is ofsufficient quality and compliance to support analysis and are usable and relevant to PD and prodromal PD patients with varying ranges of speech symptom severity.… The purpose of this study is to determine whether smartphone app-based digital speech assessments can provide speech data that is of sufficient quality and compliance to support analysis and are usable and relevant to PD and prodromal PD patients with varying ranges of speech symptom severity. Eligibility Criteria IRB number STU00216902 Copy Study URL to Clipboard Copy |
A STUDY TO EVALUATE THE SAFETY, BIOMARKERS, AND EFFICACY OF TOMINERSEN IN INDIVIDUALS WITH PRODROMAL AND EARLY MANIFEST HUNTINGTON’S DISEASEThe purpose of this study is to evaluate the safety of tominersen compared with placebo. The study drug will be administered via intrathecal injection. Eligibility Criteria Copy Study URL to Clipboard Copy |
A Multi-Center, Controlled Study to Evaluate Use of CereGate Therapy to Reduce Freezing of Gait in Participants Diagnosed with Parkinson’s DiseaseThe primary objective of this study is to determine whether adjunctive use of Ceregate therapy reduces freezing of gait (FOG) in participants diagnosed with Parkinson's disease.… The primary objective of this study is to determine whether adjunctive use of Ceregate therapy reduces freezing of gait (FOG) in participants diagnosed with Parkinson's disease. Eligibility Criteria Participants diagnosed with Parkinson’s Disease (PD) and previously implanted with a subthalamic nucleus deep brain stimulation (STN-DBS) System. Copy Study URL to Clipboard Copy |
Evoked Compound Action Potentials for Parkinson’s Disease (eCAP-PD) Study: A prospective, multicenter, single-arm feasibility study examining ECAP-controlled, closed-loop spinal cord stimulation for Parkinson’s DiseaseThe purpose of this study is to evaluate the safety and initial efficacy of ECAP-controlled closed-loop spinal cord stimulation (SCS) to treat patients with Parkinson’s Disease symptoms.… The purpose of this study is to evaluate the safety and initial efficacy of ECAP-controlled closed-loop spinal cord stimulation (SCS) to treat patients with Parkinson’s Disease symptoms. Eligibility Criteria Subject must have moderate/severe freezing of gait and/or tremor considered as a significant source of impairment in the management of their Parkinson's disease. Copy Study URL to Clipboard Copy |
Stress System Regulation in InsomniaInsomnia disorder is common among older adults and is associated with an increased risk of developing cognitive impairment. However, the nature of this association is not well understood. The purpose of this research is to examine the relationship that links physiological arousal (the stress system) with sleep and cognitive function … Insomnia disorder is common among older adults and is associated with an increased risk of developing cognitive impairment. However, the nature of this association is not well understood. The purpose of this research is to examine the relationship that links physiological arousal (the stress system) with sleep and cognitive function in older adults with insomnia and good sleeper controls. Eligibility Criteria People 55 years and older with 1) chronic insomnia (trouble falling asleep or staying asleep) or 2) good sleepers. Exclusion criteria include: 1) Sleep disorders other than insomnia; 2) Habitual bedtime before 9pm or morning awakening before 5am; 3) History of neurological disorders; 4) History of psychiatric disorders (e.g., depression, anxiety); 5) Cognitive impairment; 6) Diabetes; 7) Current, or use within the past month, of psychoactive, hypnotic, stimulant or analgesic medications (except occasionally); 8) Use of Beta-blockers 9) Hormone replacement therapy; 10) Shift work or other types of self-imposed irregular sleep schedules. Location(s)
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