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Northwestern University Feinberg School of Medicine
The Ken & Ruth Davee Department of Neurology
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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
National Parkinson Foundation Patient Registry
The purpose of this study is to collect registry data to examine the relationship between clinical symptoms and treatment in PD patients. Data collected will be used to describe differences in current treatment practices across many sites to evaluate tre…
The purpose of this study is to collect registry data to examine the relationship between clinical symptoms and treatment in PD patients. Data collected will be used to describe differences in current treatment practices across many sites to evaluate treatment and ultimately improve patient care.
• Patients diagnosed with idiopathic Parkinson’s Disease
• Must have established care with a movement disorder specialist at Northwestern
Simuni, TatyanaSimuni, Tatyana
  • Map it Lavin Pavillion 259 E. Erie St., Suite 19-100
    Chicago, IL
STU00014255
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Friedeck, Heidi 312 503 1522
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The Parkinson’s Progression Markers Initiative (PPMI)
This is a observational, multi-center study to assess progression of clinical features, imaging and biologic biomarkers in Parkinson disease (PD) patients compared to healthy controls (HC) and in PD patient subtypes. …
This is a observational, multi-center study to assess progression of clinical features, imaging and biologic biomarkers in Parkinson disease (PD) patients compared to healthy controls (HC) and in PD patient subtypes. The primary objective of this study is to identify clinical, imaging and biologic markers of PD progression for use in clinical trials of disease-modifying therapies.
Genetic Cohort-PD Subjects
• Have at least two of the following: resting tremor, slowness of movement, muscle rigidity
• Parkinson disease diagnosis for 7 years or less
• Male or female 18 years or older
• Confirmation of LRRK2, GBA, or SNCA genetic mutation
• Willing to undergo genetic testing

Genetic Cohort-Unaffected Subjects
• 50 years or older with LRRK2/GBA mutation or first degree relative with LRRK2/GBA mutation
• Willing to undergo genetic testing
OR
• 30 years or older with SNCA mutation or first degree relative with SNCA mutation
• Willing to undergo genetic testing
Simuni, TatyanaSimuni, Tatyana
  • Map it Lavin Pavillion 259 E. Erie St., Suite 19-100
    Chicago, IL
NCT01141023 STU00031752
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Friedeck, Heidi 312 503 1519
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Peripheral Neuropathy Research Registry (PNRR)
National Peripheral Neuropathy Research Registry, a collection of different types of information, such as patient medical, family, and social histories and blood samples. The information is carefully maintained so that it can be studied repeatedly in t…
National Peripheral Neuropathy Research Registry, a collection of different types of information, such as patient medical, family, and social histories and blood samples. The information is carefully maintained so that it can be studied repeatedly in the future. The registry aims to help researchers’ access large amounts of information about people with PN. By using this registry, researchers will facilitate both basic and clinical research studies that will bring improved understandings of the etiology (origination) and pathogenesis (development) of PN. They will specifically ask why some patients with peripheral neuropathy develop neuropathic pain and others do not, and what the characteristics of patients with painful peripheral neuropathy are in terms of their symptoms, examination findings, and blood tests. Ultimately this research may result in improved 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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Joslin, Benjamin 312 503 7504
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Maternal Outcomes and Neurodevelopmental Effects of Antiepileptic Drugs (MONEAD)
The purpose of this study is to observe mothers with and without epilepsy, along with their children, from pregnancy until age 6 and assess the developmental and neurocognitive influence of anti-epileptic medications.
Gerard, Elizabeth ErwayGerard, Elizabeth Erway
NCT01730170 STU00070411
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Bellinski, Irena Iva 312 926 1672
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Non-Invasive Marker of Ovarian Reserve in Women with Epilepsy
The purpose of this study is to assess and compare AMH hormone levels in women with epilepsy vs. healthy controls, utilizing medical history questionnaires and a finger stick.
Gerard, Elizabeth ErwayGerard, Elizabeth Erway
STU00077630
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Bellinski, Irena Iva 312 926 1672
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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 add…

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, PriyaKumthekar, Priya
  • Map it 201 E. Huron St.
    Chicago, IL
STU00087359
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Study Coordinator 1 312 695 1102
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Parkinson’s Disease and Movement Disorders Center 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 regi…
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 5 years of age or older when diagnosed
• Genetic mutation related to a movement disorder
• Family members of patients with movement disorders
Simuni, TatyanaSimuni, Tatyana
  • Map it Lavin Pavillion 259 E. Erie St., Suite 19-100
    Chicago, IL
STU00091585
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Hernandez, Alejandro +1 312 503 2778
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rTMS: A Treatment to Restore Function after Severe TBI
The purpose of this study is to address the need for targeted treatments that induce functional and structural changes in the brain, ultimately improving neurobehavioral functioning, the investigators propose examining the therapeutic effectiven…
The purpose of this study is to address the need for targeted treatments that induce functional and structural changes in the brain, ultimately improving neurobehavioral functioning, the investigators propose examining the therapeutic effectiveness of repetitive Transcranial Magnetic Stimulation (rTMS). The objective is to improve functional recovery for persons remaining in vegetative (VS) and minimally conscious (MCS) states 3 to 12 months after severe TBI. The approach is to determine the neurobehavioral effect of rTMS, the relationship between neurobehavioral changes and net neural effects, and to identify and define the neural mechanisms related to neurobehavioral improvements by providing 30 active or placebo rTMS sessions.
Inclusion Criteria:
-Veteran of any combat era
-Both Genders
-20-65 years
-History of Post Traumatic Amnesia < 1 day for mild TBI; 1 day> x < 7days for moderate TBI))
-Ability to obtain a Motor Threshold (MT) will be determined during the screening process.
-If on a psychotropic medication regimen, that regimen will be stable for at least 4 weeks prior to entry to the study and patient will be willing to remain on a stable regimen during the acute treatment phase.
-Has an adequately stable condition and environment to enable attendance at scheduled clinic visits.
-For female participants, agrees to use one of the following acceptable methods of birth control: abstinence, oral contraceptive; Norplant
-Able to read, verbalize understanding, and voluntarily sign the Informed Consent Form prior to participating in any study-specific procedures or assessments.

Exclusion Criteria:
-Pregnant or lactating female.
-Unable to be safely withdraw, at least two-weeks prior to treatment commencement, from medications that substantially increase the risk of having seizures
-Have a cardiac pacemaker or a cochlear implant
-Have an implanted device (deep brain stimulation) or metal in the brain (see standard MRI exclusion criteria including metal screening section in telephone screen, Appendix A).
-Have a mass lesion, cerebral infarct or other active central nervous system (CNS) disease, including a seizure disorder.
-Known current psychosis as determined by DSM-IV coding in chart (Axis I, psychotic disorder, schizophrenia) or a history of a non-mood psychotic disorder.
-Diagnosis of Bipolar Affective Disorder (as determined by chart review and intake interview)
-Current amnesic disorders, dementia, mini mental state examination (MMSE) 24 or delirium.
-Current substance abuse (not including caffeine or nicotine) as determined by positive toxicology screen, or by history via AUDIT, within 3 months prior to screening
-Prior history of seizures
-Severe TBI or open head injury
-TBI within last two months or in acute stage
-Participation in another concurrent clinical trial
-Patients with prior exposure to rTMS/ECT
-Active current suicidal intent or plan. Patient at risk for suicide will be required to establish a written safety plan involving their primary psychiatrist and the treatment team before entering the clinical trial
Pape, Theresa L Bender LPape, Theresa L Bender L
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02366754 STU00103966
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Walsh, Elyse 708 968 0427
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Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial (CREST-2) P
Carotid revascularization for primary prevention of stroke (CREST-2) is a multicenter, randomized controlled trials of carotid revascularization and intensive medical management versus medical managem…
Carotid revascularization for primary prevention of stroke (CREST-2) is a multicenter, randomized controlled trials of carotid revascularization and intensive medical management versus medical management alone in patients with asymptomatic high-grade carotid stenosis. One trial will randomize patients in a 1:1 ratio to endarterectomy versus no endarterectomy and another will randomize patients in a 1:1 ratio to carotid stenting with embolic protection versus no stenting. Medical management will be uniform for all randomized treatment groups and will be centrally directed.
Eskandari, MarkEskandari, Mark
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02089217 STU00200290
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Reinkensmeyer, Alexandra 312 695 4189
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Mechanisms of Early Recurrence in Intracranial Atherosclerotic Disease (MyRIAD)
The objective of this study is to determine the mechanisms of stroke in patients with Intracranial Atherosclerotic Disease (IAD) by specifically evaluating limitations of antegrade flow through…
The objective of this study is to determine the mechanisms of stroke in patients with Intracranial Atherosclerotic Disease (IAD) by specifically evaluating limitations of antegrade flow through the stenotic artery, distal tissue perfusion to the affected territory, and artery-to-artery embolism. The hypothesis is that non-invasive imaging biomarkers that stratify stroke risk and distinguish mechanisms of IAD. This prospective multicenter study will enroll 175 patients with recently symptomatic high-grade IAD. Patients will be studied within 21 days of the index event (allowing appropriate time to arrange for diverse imaging modalities), with the following advanced neuroimaging techniques to elucidate mechanisms of recurrent ischemia: - Quantitative magnetic resonance imaging (QMRA) to assess volumetric flow rate through the stenotic artery. - Magnetic resonance perfusion weighted imaging (PWI-MRI) to determine distal tissue perfusion. - Vasomotor reactivity by Transcranial Doppler using the breath-holding technique (BHI-TCD) to assess compensatory flow characteristics to the territory distal to the affected artery; - Transcranial Doppler with embolic signal monitoring to evaluate artery-to-artery embolism that reflects plaque instability. Patients will receive standardized medical management and its effectiveness on blood pressure, lipid, and glycemic control will be monitored. The primary outcome is recurrent stroke in the territory of the stenotic artery during a 1-year follow-up period; secondary outcomes are: a) new asymptomatic ischemic lesions on MRI in the distribution of the stenotic artery at 6-8 weeks, and b) transient ischemic attack (TIA) in the distribution of the stenotic artery during a 1-year follow-up period. Patients will be recruited at various sites that will be trained and certified on the imaging techniques employed. Raw imaging data will be interpreted centrally.
Inclusion
1- Symptomatic stroke/TIA due to IAD

2- Stenosis 70-99% measured on CTA/DSA/MRA as SOC (WASID criteria) and MRA flow gap (send to bay state)


3-Stroke/TIA diagnosed on CT or MRI

3- TIA with DWI abnormalities or ≥2 stereotyped events (weakness, aphasia)

5- IAD-Intracranial Carotid
MCA, Intracranial Vertebral,
Basilar

6- Age >30;
7- 30-49 also IAD in another vascular bed (coronary, extracranial carotid, peripheral) or the presence of 2 or more risk factors (hypertension, diabetes mellitus, hyperlipidemia, tobacco abuse within the last 2 years).

8- Enrollment within 21 days of index event

.
Exclusion
1- No ACA No PCA
2- Other cause of stroke/TIA besides ICAD
3- Angioplasty/stenting performed or planned on target vessel or on a vessel proximal to it.
4- Contraindications to MRI,
5- Pregnancy, lactation, morbid obesity, and severe claustrophobia.
6- Cr >1.5 mg/dL or GFR
Ansari, Sameer AhmadAnsari, Sameer Ahmad
NCT02121028 STU00202274
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Muzaffar, Ayesha 312 926 4251
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Alliance A071401: Phase II Trial Of SMO/AKT/NF2 Inhibitors in Progressive Meningiomas with SMO/AKT/NF2 Mutations

This phase II trial studies how well two drugs, vismodegib and GSK2256098, work in treating patients with meningiomas that may have gotten bigger or grew back after treatment. Vismodegi…

This phase II trial studies how well two drugs, vismodegib and GSK2256098, work in treating patients with meningiomas that may have gotten bigger or grew back after treatment. Vismodegib and GSK2256098 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

The purpose of this study is to test good and bad effects of these two different drugs against meningioma tumors with altered (or mutated) genes. Altered genes can cause a tumor to grow. The study drugs, vismodegib and GSK2256098, target these genes. The study drugs could shrink the cancer, or the cancer could stay the same size or grow. They may cause side effects. Researchers hope to learn if the study drugs will shrink the cancer by at least one-half compared to its present size.

Today, therapy for meningioma is the same for all patients, and is not based on tumor genetic testing. This trial is trying to see if tumor genetic testing would be helpful at guiding treatment in meningioma patients.

You may be eligible for this research study if you have a meningioma which has gotten bigger or grew back after treatment.

Kumthekar, PriyaKumthekar, Priya
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02523014 STU00202953
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Study Coordinator 312 695 1102
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Multidisciplinary Treatment for Obstructive Sleep Apnea and Insomnia
The MATRICS Study - This study aims to investigate the effectiveness of different combinations and sequences of evidence-based treatment strategies for people with both Obstructive Sleep Apnea and Insomnia. Participants will be rand…
The MATRICS Study - This study aims to investigate the effectiveness of different combinations and sequences of evidence-based treatment strategies for people with both Obstructive Sleep Apnea and Insomnia. Participants will be randomly assigned to one of three treatment conditions using a medical device known as CPAP, or using this device in combination with a behavioral treatment to improve sleep.
Inclusion Criteria:
Males and Females age 18 and older;
Meets criteria for Obstructive Sleep Apnea;
Meets criteria for an Insomnia Disorder; Able to make around 15 in-person visits over 7-9 months.
Exclusion Criteria:
Comorbid medical condition that requires immediate treatment of OSA;
Severe cases of OSA that require immediate treatment;
Psychiatric conditions that may interfere with study protocol or uncontrolled psychiatric conditions that require immediate treatment;
Comorbid sleep disorders that require treatment outside of the study protocol;
Other sleep-related breathing disorder besides OSA;
Excessive daytime sleepiness that requires immediate treatment or presents significant risk;
CPAP use or formal CBT for insomnia within the past 6 months.
Ong, Jason COng, Jason C
NCT01785303 STU00203478
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Yap, Bonnie 312 503 6627
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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 i…
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, SabraAbbott, Sabra
  • Map it 201 E. Huron St.
    Chicago, IL
STU00203647
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Abbott, Sabra 312 503 3561
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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 …
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 201 E. Huron St.
    Chicago, IL
  • Map it 320 E. Superior Ave. Searle 11
    Chicago, IL
  • Map it 355 E. Erie St.
    Chicago, IL
STU00203644
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Hung, Na-Teng 312 503 4816
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A multicenter, international, open-label, safety study of ND0612, a solution of levodopa/carbidopa delivered via a pump system as a continuous subcutaneous infusion in subjects with advanced Parkinson's Disease (BeyoND)
Levodopa and Carbidopa are registered and widely used by Parkinson’s disease su…
Levodopa and Carbidopa are registered and widely used by Parkinson’s disease subjects. The medication is given as pills, whilst the study drug is given as a solution in a continuous subcutaneous infusion. This study is based on the assumption that treatment which will enable the administration of levodopa to the brain in a more continuous way compared to the current standard treatment could constitute a more effective treatment for Parkinson’s subjects, with less of the known side effects of this treatment.
Must be individual with Parkinson's disease on stable doses of Levodopa/carbidopa >4/day or Rytary >3/day with "OFF" periods ≥ 2.5 hours per day.
Simuni, TatyanaSimuni, Tatyana
  • Map it 675 N. St. Clair St. Suite 20-100
    Chicago, IL
NCT02726386 STU00203747
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Poon, Cynthia 312 503 8216
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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 wil…
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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Brown, ZsaZsa 312 503 4121
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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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Garcia-Canga, Blas +1 312 503 0492
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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 neurolo…
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 675 N. St. Clair St. Suite 20-100
    Chicago, IL
NCT01060371 STU00204294
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Brown, ZsaZsa 312 503 4121
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Multicenter, randomized, double-blind, placebo controlled study to assess the efficacy, safety, pharmacokinetics, and pharmacodynamics of GZ/SAR402671 in patients with early-stage Parkinson’s disease carrying a GBA mutation or other pre-specified variant.
A study to assess an experimental oral d…
A study to assess an experimental oral drug (GZ/SAR402671) in patients with early-stage Parkinson’s disease carrying a GBA mutation or other pre-specified variant. There are 2 parts to this trial. Part 1 will be conducted to decide what will be the best dose of the study drug to use in Part 2 of this trial. The total expected duration of this study will be approximately 11 months for Part 1 and 12 months for Part 2.
Male or female subjects with a diagnosis of PD and who are heterozygous carriers of a GBA mutation.
Simuni, TatyanaSimuni, Tatyana
  • Map it 675 N. St. Clair St. Suite 20-100
    Chicago, IL
NCT02906020 STU00204431
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Poon, Cynthia 312 503 8216
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Morning Light Treatment at Home to Improve Glucose Metabolism in People at Increased Risk for Type 2 Diabetes
The study is titled “Morning Light Treatment.” We think there may be a relationship between sleep and diabetes, and morning light treatment delivered through a head worn light device coul…
The study is titled “Morning Light Treatment.” We think there may be a relationship between sleep and diabetes, and morning light treatment delivered through a head worn light device could improve glucose metabolism in people with prediabetes.
We are looking for people ages 40-65, who are overweight or obese, do not currently have diabetes, and are in good health. The study involves screening blood tests, at-home apnea test, 5 weeks of wrist actigraphy, a 4 week period where you would wear a light device for one hour in the morning, and 2 overnight laboratory sessions that include saliva, urine, and blood samples. You will be compensated up to $525, $50 for the screening and $95 for each week of participation.
Knutson, KristenKnutson, Kristen
  • Map it 201 E. Huron St.
    Chicago, IL
STU00204710
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Knutson, Kristen
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A Randomized, Double-Blind, Placebo-Controlled, 52-Week Phase II Study to Evaluate the Efficacy of Intravenous RO7046015/Prasinezumab (PRX002) in Participants with Early Parkinson’s Disease with a 6-Year All-Participants-On-Treatment Extension (PASADENA)
This is a multicenter, Phase II study to eva…
This is a multicenter, Phase II study to evaluate the effect of IV administration of RO7046015 in participants with early stage Parkinson's Disease (PD). Participants will be eligible if they have PD with bradykinesia plus one of the other cardinal signs of PD (resting tremor, rigidity) being present, without any other known or suspected cause of PD and are either untreated or treated with Azilect or Selegiline. The study will consist of two parts: a 52-week, treatment period of the study medication vs placebo (Part 1) after which eligible participants will continue into an all-participants-on-treatment (RO7046015) blinded to dose extension for an additional 52 weeks (Part 2).
*Men and women, aged 40 to 80 years inclusive, early PD , who were recently (< 2 years) diagnosed, and either untreated or treated with Azilect or Selegiline
Simuni, TatyanaSimuni, Tatyana
  • Map it Lavin Pavillion 259 E. Erie St., Suite 19-100
    Chicago, IL
NCT03100149 STU00205125
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Poon, Cynthia 312 503 8216
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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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Bellinski, Irena Iva 312 926 1672
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cIRB: Topiramate as a disease altering therapy for Cryptogenic Sensory Peripheral Neuropathy (CSPN)
This is a 96-week placebo-controlled trial of topiramate at a target dose of 100 mg daily (50 mg twice daily) as a potentially disease altering therapy for Cryptogenic Sensory Peripheral Neuropathy
INCLUSION: 1. Age 18-75; 2. Diagnosis of confirmed cryptogenic symptomatic distal symmetric peripheral polyneuropathy; 3. Prediabetes based on American Diabetes Association; 4. No history of prior therapy with topiramate; 5. Waist circumference >102 cm for men, >88 cm for women
Menichella, DanielaMenichella, Daniela
  • Map it Lavin Pavillion 259 E. Erie St., Suite 19-100
    Chicago, IL
NCT02878798 STU00206049
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Houseman, Justine +1 312 695 2296
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Microburst VNS Therapy Feasibility Study in Subjects with Refractory Epilepsy
The purpose of this study is for patients with first-time implants of a Vagus Nerve Stimulator (VNS) to have the new Microburst stimulation settings optimized using fMRI scans.
Macken, Micheal PMacken, Micheal P
NCT01281293 STU00206259
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Bellinski, Irena Iva 312 926 1672
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cIRB: AtRial Cardiopathy and Antithrombotic Drugs In prevention After Crypotgenic Stroke
ARCADIA is a multicenter, biomarker-driven, randomized, double-blind, active-control, phase 3 clinical trial of apixaban versus aspirin in patients who have evidence of atrial cardiopathy and a recent stroke of u…
ARCADIA is a multicenter, biomarker-driven, randomized, double-blind, active-control, phase 3 clinical trial of apixaban versus aspirin in patients who have evidence of atrial cardiopathy and a recent stroke of unknown cause. Eleven hundred subjects will be recruited over 2.5 years at 120 sites in the NINDS StrokeNet consortium. Subjects will be followed for a minimum of 1.5 years and a maximum of 4 years for the primary efficacy outcome of recurrent stroke and the primary safety outcomes of symptomatic intracranial hemorrhage and major hemorrhage other than intracranial hemorrhage.
Inclusion Criteria:

1) Age ≥ 45 years.
2) Clinical diagnosis of ischemic stroke + brain imaging to rule out hemorrhagic stroke.
3) Modified Rankin Scale (MRS) score ≤ 4.
4) Ability to be randomized within 3 to 120 days after stroke onset.
5) ESUS, defined as all of the following:
Stroke detected by CT or MRI that is not lacunar. Lacunar is defined as a subcortical (this includes pons and midbrain) infarct in the distribution of the small, penetrating cerebral arteries whose largest dimension is ≤1.5 cm on CT or ≤2.0 cm on MRI diffusion images/
Caprio, FanCaprio, Fan
  • Map it 675 N. St. Clair St. Suite 20-100
    Chicago, IL
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03192215 STU00206251
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Garcia-Canga, Blas +1 312 503 0492
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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 Lavin Pavillion 259 E. Erie St., Suite 19-100
    Chicago, IL
STU00206988
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Brown, ZsaZsa 312 503 4121
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A Phase 3, Randomized, Rater-Blinded, Multi-Center Study to Evaluate the Efficacy and Safety of ALXN1840 Administered for 48 Weeks Versus Standard of Care in Patients with Wilson Disease Aged 12 Years and Older with an Extension Period of Up to 60 Months
The primary objective of this study is to eval…
The primary objective of this study is to evaluate the efficacy of the drug WTX101 administered for 48 weeks, compared to standard of care (SoC), on copper (Cu) control in subjects with Wilson's disease aged 18 and older.
Diagnosis of Wilson's Disease, Treatment for >28 days with chelation therapy, Zn therapy or a combination of chelator and Zn; willing to avoid the use of vitamins and/or minerals containing CU, Zn or Mo throughout the study, willing to undergo > 48-hour washout from current WD treatment
Bega, DannyBega, Danny
  • Map it Lavin Pavillion 259 E. Erie St., Suite 19-100
    Chicago, IL
NCT03403205 STU00206921
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Brown, ZsaZsa 312 503 4121
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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 …
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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    Moroni, Francesca +1 312 503 0018
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    Radicava® (Edaravone) Biomarker Study in Participants with Amyotrophic Lateral Sclerosis
    REFINE-ALS is a prospective, observational, longitudinal, multicenter study designed to identify biomarkers to serve as quantifiable biological non-clinical measures of Edaravone effects in ALS. Epigenetic and p…
    REFINE-ALS is a prospective, observational, longitudinal, multicenter study designed to identify biomarkers to serve as quantifiable biological non-clinical measures of Edaravone effects in ALS. Epigenetic and protein biomarkers will also be investigated.
    Ajroud-Driss, SendaAjroud-Driss, Senda
    STU00210057
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    Joslin, Benjamin
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    Natural history study of ALS and other motor neuron disorders

    The purpose of this research study is to collect clinical information from people living with ALS and other motor neuron disorders through the natural history of their disease. Data is obtained from the participants during their standar…

    The purpose of this research study is to collect clinical information from people living with ALS and other motor neuron disorders through the natural history of their disease. Data is obtained from the participants during their standard of care visits and by reviewing their medical records.

    The objective of compiling clinical, phenotypic data over the course of the participants’ disease history is to identify clinical similarities, improve our understanding of these diseases longitudinally, and identify avenues for novel treatment.

    Ajroud-Driss, SendaAjroud-Driss, Senda
    STU00209860
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    Joslin, Benjamin
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    Oxidative Markers and Efficacy in ALS/MND Phenotypes Treated with Edaravone
    This is a non-intervention study evaluating blood markers and efficacy in ALS/MND patients treated with FDA-approved edaravone (Radicava).

    We are only recruiting patients who have not started their edaravone treatmen…

    This is a non-intervention study evaluating blood markers and efficacy in ALS/MND patients treated with FDA-approved edaravone (Radicava).

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

    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 Lavin Pavillion 259 E. Erie St., Suite 19-100
      Chicago, IL
    NCT04097158 STU00211350
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    Joslin, Benjamin 312 503 7504
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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.
    The HEALEY ALS Platform Trial is a perpetual multi-center, multi-regimen clinical tr…
    The HEALEY ALS Platform Trial is a perpetual multi-center, multi-regimen clinical trial evaluating the safety and efficacy of investigational products for the treatment of ALS. This trial is designed as a perpetual platform trial. This means that there is a single Master Protocol dictating the conduct of the trial.

    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

    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.

    Ajroud-Driss, SendaAjroud-Driss, Senda
    STU00212680
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    ALS Platform

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    Joslin, Benjamin
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    A Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BIIB067 Administered to Adult Subjects with Amyotrophic Lateral Sclerosis and Confirmed Superoxide Dismutase 1 Mutation
    This is a randomized, double-blind, placebo-controlled, 3-part dose escalation stud…
    This is a randomized, double-blind, placebo-controlled, 3-part dose escalation study to examine the efficacy, safety, tolerability of BIIB067, administered by intrathecal bolus injection to up to approximately 183 adult subjects with ALS and confirmed SOD1 mutation.Northwestern is only participating in Part C of this study.The primary objective of Part C of this study is to evaluate the clinical efficacy of BIIB067 administered to adult subjects with ALS, who are fast-progressing, and confirmed SOD1 mutation.
    Ajroud-Driss, SendaAjroud-Driss, Senda
    • Map it Lavin Pavillion 259 E. Erie St., Suite 19-100
      Chicago, IL
    NCT02623699 STU00211658
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    ALS SOD1

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    Joslin, Benjamin
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