Office of Research
Clinical Trials

Leading the Future of Clinical Medicine
The College of Medicine is a hub for groundbreaking clinical research. With over 30 specialized research units, our teams are dedicated to translating laboratory discoveries into life-saving clinical applications. From neurology to oncology, we provide the infrastructure and expertise necessary to push the boundaries of modern medicine.

Browse our Research Units below to view current study listings.

Clinical Trials Search

Russell Sawyer, MD

Russell Sawyer, MD

Memory Disorders

Study on Alzheimer's Disease Risk in Adults with Down Syndrome

This study aims to form a trial-ready group of adults with Down Syndrome (DS). It includes 120 healthy participants aged 25-55. Researchers will conduct cognitive and clinical tests to analyze relationships between brain markers and cognitive abilities. The goal is to improve future Alzheimer's clinical trials, focusing on disease patterns specific to people with DS. Participants will share data with another ongoing study for more comprehensive research outcomes.

Learn More about Study on Alzheimer's Disease Risk in Adults with Down Syndrome
Stacie Demel, DO, PhD

Stacie Demel, DO, PhD

Subacute

DECADE-Brain Health study

Intracerebral hemorrhage (ICH) is the most extreme subtype along the spectrum of CSVD that includes white matter hyperintensity (WMH), small vessel (lacunar) ischemic stroke and vascular cognitive impairment. We propose to re-enroll 400 (275 non-Hispanic European descent and 125 African-descent) participants of i3C DECADE study, (MPI: Bazzano, Urbina and Carmichael) which is following biracial cohorts in the Cincinnati, Ohio regions originally recruited as children in the 1970s and 1980s, for a 3-year (+/- 6 months) follow-up MRI, additional serial cognitive examinations and detailed dietary histories which will include a polyamine specific history and serial blood sampling. The proposal will copy the i3C DECADE exam including an identical MRI protocol and use the same recruitment and retention tools.

Aram Zabeti, MD

Aram Zabeti, MD

Multiple Sclerosis

Phase 1

Studying TRX319 Cell Therapy for Progressive Multiple Sclerosis

This research study is testing an investigational cell therapy called TRX319 for adults with primary progressive multiple sclerosis (PPMS) or secondary progressive multiple sclerosis (SPMS). The goal is to learn whether TRX319 is safe and to look for signs that it may help slow or improve disease progression. Participants will receive a single intravenous infusion of TRX319. Some participants may also receive bendamustine before the infusion, depending on the study group. The study includes screening tests, physical examinations, blood tests, MRI scans, spinal fluid testing, and assessments of walking, hand function, vision, and thinking abilities. Participants will be followed for about one year after treatment. Information from this study may help researchers develop new treatment options for people with progressive forms of multiple sclerosis.

Zheming Yu, MD

Zheming Yu, MD

Movement Disorders

Improving Sleep and Thinking in People with Parkinson Disease Using Different Brain Stimulation Settings

This study is testing whether changing the settings of an implanted brain stimulation device during sleep can improve sleep quality and thinking abilities in people with Parkinson disease. Participants who already have a deep brain stimulation device will receive two different stimulation settings in a random order. One setting uses their usual stimulation day and night, while the other uses a lower setting during sleep. Participants will complete sleep questionnaires, thinking and memory tests, and movement assessments during the study. Researchers hope to learn whether nighttime brain stimulation changes can improve sleep and thinking without worsening movement symptoms.

Alberto Espay, MD

Alberto Espay, MD

Parkinson's disease | Movement Disorders

SPARX3

This study is a Phase III multi-site, randomized, evaluator-masked, study of endurance exercise on 12 month, 18 month, and 24 month changes in the MDS-UPDRS Part III score. 370 participants will be randomly assigned to 2 groups: 1)60-65% HRmax and 2)80-85% HRmax 4 times per week. Secondary aims will test hypotheses related to ambulatory mobility, daily activity, cognition, fitness, quality of life, measures of dopaminergic neuronal integrity and blood-derived biomarkers of inflammation and neurotrophic factors.

Learn More about SPARX3
513-558-4811

Michael D. Privitera, MD

Epilepsy

Phase 1

Cannabidiol for Focal Seizures Study

This is an open-label, single-group study testing a cannabidiol (CBD) oral solution as an extra medicine for people with focal-onset seizures aged 12 to 75. Participants will keep their current anti-seizure medicines (1 to 4 drugs) and add the CBD solution. The main goal is to see whether CBD lowers the number of focal seizures compared to each person's baseline over about 16 weeks. The study will also look at safety, how the body handles the drug (pharmacokinetics), and whether brain imaging (fMRI) or thinking tests predict who responds best. Some people in the study may be early in their treatment and others may have hard-to-treat seizures. The study does not include people with non-epileptic events, recent CBD or cannabis use, certain allergies, or unstable medical or mental-health issues.

Learn More about Cannabidiol for Focal Seizures Study
Hani Kushlaf, MD

Hani Kushlaf, MD

Neuromuscular

Phase 3

Riliprubart for Refractory CIDP

This is a Phase 3 clinical trial testing riliprubart, given to adults with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) whose disease did not respond well to usual treatments (IVIg or steroids). Participants are randomly assigned to receive riliprubart or placebo. The first part (double-blind) compares effects through Week 24 and up to Week 48 for some outcomes. After that, an open-label part allows longer treatment and safety follow-up up to a maximum of 111 weeks. The main goal is to measure how many people have meaningful improvement in disability scores (a drop of at least 1 point on the adjusted INCAT scale) by Week 24 and whether improvements last. The study also checks strength, fatigue, quality of life, side effects, and whether the body makes antibodies to riliprubart. People must meet specific diagnosis and stability rules and must not have other causes of neuropathy or recent conflicting treatments. Vaccinations and contraception rules apply.

Learn More about Riliprubart for Refractory CIDP
Alberto Espay, MD

Alberto Espay, MD

Parkinson's disease | Movement Disorders

Dystonia Coalition Projects-3

The overall mission of the Dystonia Coalition is to develop a better understanding of the dystonias so that we may improve treatment. Presently, there are four related projects; the first three projects are grouped together because they are related. The last project will be open only to selected participants as an option. 1. Natural History (NH) Project: The aim of this observational project is to better characterize the heterogeneity of clinical manifestations among subjects with dystonia, how these manifestations evolve over time, and how they relate to other family members. A fuller understanding of clinical features and especially their evolution over time is an essential prerequisite for testing any potential disease-modifying therapies that could alter the course of the disorder. 2. Objective Measures (OM) Project: The aim of this project is to exploit technological advances for development of objective tools to measure the severity of dystonia. Current diagnostic and severity measures depend almost entirely on subjective clinician-rated or patient-rated scales. New technology could ultimately replace these subjective scales as outcome measures. They could also be used for telemedicine. This study is not interventional, but instead relies on video recordings or motion sensors that can non-invasively detect movements. 3. Biobank (BB) Project: The aim of this project is to develop a resource that expands the existing dystonia DNA biorepository to include other biomaterials. To date, no large multicenter open-access biorepository exists for any type of dystonia. Such a biobank is essential for improving our understanding of the pathogenesis of the dystonias, so that rational therapies can be planned. It also is essential for exploration of biomarkers of disease activity that may provide useful outcome measures in clinical trials, or insights into pathogenesis. This study also is not interventional. 4. Patient-Centered Outcomes (PCO) Project: The aim of this project is to delineate both between-subject and within-subject variations over time in response to the standard of care treatment with Botulinum toxin (BoNT) injections. Typically, injections are required about every 3 months. Therapeutic benefits emerge within the first week and then wear off after 8-16 weeks, creating a cyclical response known as the "yo-yo" effect. The development of any novel "add-on" therapeutics or replacement therapeutic is hampered by incomplete knowledge of individual temporal responses. Currently, measurement tools rely on clinical rating scales which are subjective, cumbersome for repeated frequent use, and require extensive expertise to apply. This project will develop a patient-facing tool on a hand-held electronic device, such as a smartphone. This is not an interventional study; it aims to collect data regarding responses to routine clinical treatments.

Wole Awosika, MD

Wole Awosika, MD

Acute

Early Stroke Recovery Biomarkers

This study will test whether simple, early medical tests can predict how well a person's arm recovers after an ischemic stroke. Many people have lasting arm weakness after a stroke. Doctors want reliable markers to tell which patients will do well and which will not. VERIFY will enroll people shortly after an ischemic stroke and collect three types of information: clinical exams of arm strength and function, brain stimulation tests (TMS) that check motor pathways, and MRI brain scans that measure injury to the main motor pathway. The study will follow participants for 90 days and measure arm impairment, arm function, and how much the arm is used in daily life. The goals are to validate that TMS and MRI measures taken early predict 90-day arm outcomes and to test a prediction tool called PREP2 in many centers. About 650 participants across up to 45 sites are planned. The results aim to help select the right patients for future recovery trials and to guide early rehabilitation decisions.

Learn More about Early Stroke Recovery Biomarkers
David Robinson, MD, MS

David Robinson, MD, MS

Acute | Neurotrauma | Neuro-critical care | General

Evaluating brain injury from subdural hematomas using advanced imaging

We hope to conduct advanced MRIs on patients. We think these MRIs will help better understand how subdural hematomas injure the brain and keep people from fully recovering once the blood goes away.

Stacie Demel, DO, PhD

Stacie Demel, DO, PhD

Acute

StrokeNet Thrombectomy Platform

STEP is a large, multi-center study testing ways to improve care for people who have an acute ischemic stroke caused by a blockage in a large or medium brain artery. The trial runs at many stroke centers and is set up so new treatments can be added over time. It studies several types of approaches: broadening who might get endovascular thrombectomy (a clot-removal procedure), testing new devices used during clot removal, testing medicines given along with the procedure, and testing early or pre-hospital tools and systems to speed care. People are randomly assigned to treatments so researchers can compare results. The main goal is to see which options help people have less disability 90 days after their stroke, while watching for harms like bleeding or death. The study adapts as results come in, so it can stop or expand parts that look better or worse.

Learn More about StrokeNet Thrombectomy Platform
Rhonna Shatz, DO

Rhonna Shatz, DO

Memory Disorders

Bringing Efficiency to the Early Alzheimer's Disease Diagnosis

This study is testing a new way to help doctors identify memory and thinking changes earlier. Adults age 50 and older who report concerns about memory or behavior may complete simple digital thinking tests at home and in the clinic, along with a blood test that looks for signs of Alzheimer's disease. The goal is to see whether this new approach helps people get a diagnosis faster and more accurately. Participants meet with a brain health team, complete questionnaires and thinking tasks, and then receive results from a trained primary care provider.

Lawrence Goldstick, MD

Lawrence Goldstick, MD

Multiple Sclerosis

Phase 3

Ublituximab Modified Regimen Study

This Phase 3b study tests a changed dosing plan of ublituximab, a medicine that targets B cells, in people with relapsing multiple sclerosis (RMS). The study has three parts: Part A is open to eligible participants and looks at MRI brain lesions over about 48 weeks; Part B is randomized and double-blind to study drug levels and compare to placebo up to 16 weeks; Part C enrolls people who had a suboptimal experience on another anti-CD20 treatment to see how they do on ublituximab. Main goals are to see if the modified schedule prevents new gadolinium-enhancing MRI lesions and to understand the drug's blood levels. Participants have regular visits for dosing, safety checks, and MRI scans. People with active infections, certain immune diseases, prior serious infusion reactions to anti-CD20 drugs, some prior cancer or prior use of specific immunosuppressive drugs are not allowed to join.

Learn More about Ublituximab Modified Regimen Study
Andrew Duker, MD

Andrew Duker, MD

Huntington's disease | Movement Disorders

Phase 1

Testing a One-Time Gene Therapy for Huntington's Disease

This research is studying a new gene therapy for adults with Huntington's disease. The treatment is given once, during brain surgery, into two areas that are affected by the disease. The goal is to learn if the therapy is safe and whether it can slow down symptoms and help people stay independent longer. Some participants will receive the gene therapy right away, and others will have a sham surgery and may receive the therapy later. Participants will have regular checkups, brain scans, thinking and movement tests, and will use a smartphone and a wrist sensor to track daily activity. Follow-up lasts several years to monitor health and any benefits or side effects. Eligibility includes adults aged 25 to 65 with confirmed Huntington's disease.

Learn More about Testing a One-Time Gene Therapy for Huntington's Disease
Hani Kushlaf, MD

Hani Kushlaf, MD

Neuromuscular

Phase 3

(IV) loading dose , followed 1 week later by DNTH103 (300 mg) administered subcutaneously (SC) every 2 weeks

This is a Phase 3 clinical trial testing DNTH103 in adults with CIDP. The study starts with an open treatment period (Part A, up to 13 weeks) where all participants receive DNTH103. People who respond in Part A may move into a randomized, double-blind, placebo-controlled period (Part B, up to 52 weeks) where they get either DNTH103 or placebo and neither they nor the study team know which. There is an optional open-label extension (OLE) of up to 104 weeks for eligible participants, plus a 40-week safety follow-up. The main goal is to see how long it takes for participants to relapse on study treatment, using standard disability and strength measures. The study also tracks other measures of disability, grip strength, fatigue, quality of life, drug levels in the blood, immune responses to the drug, and any side effects. Vaccination against certain bacteria is required before joining. The study seeks adults who meet set stability and disability scores and who meet treatment history criteria (including those currently treated with standard therapies, those who failed them, or those never treated).

Learn More about (IV) loading dose , followed 1 week later by DNTH103 (300 mg) administered subcutaneously (SC) every 2 weeks
John G. Quinlan, MD

John G. Quinlan, MD

Neuromuscular

Using Voice Recordings to Measure Lung Function

This research is studying whether simple voice recordings, like counting out loud or holding a sound, can help measure lung function. It includes adults with neuromuscular diseases and healthy volunteers. These voice tests may help doctors monitor breathing when standard lung tests are difficult or unavailable.

Stacie Demel, DO, PhD

Stacie Demel, DO, PhD

Subacute

Endovascular Treatment in Disabled Stroke

This is a prospective, observational study at multiple stroke centers to compare two commonly used care approaches for people who had moderate-to-severe disability before getting a large-vessel ischemic stroke. One approach is standard medical care (medications, blood pressure and cholesterol control, rehab and other supportive measures) and the other adds endovascular thrombectomy (mechanical removal of the clot). The study will enroll adults with pre-stroke disability (moderate to severe) who arrive within 24 hours of stroke symptoms and have a large artery blockage on brain imaging. The main goal is to compare how patients do at about 90 days after treatment-measuring functional outcome, return to prior level, quality of life, and safety (including death and bleeding in the brain). Results aim to guide care decisions for stroke patients who already had disabilities before their stroke.

Learn More about Endovascular Treatment in Disabled Stroke
Alberto Espay, MD

Alberto Espay, MD

Multiple Sclerosis

Understanding genetic Parkinson's disease

This study looks at people with a rare genetic form of Parkinson's disease and their family members. Researchers collect samples like blood, spinal fluid, and skin to better understand how the disease develops. The goal is to improve understanding of Parkinson's disease causes.

Abhimanyu Mahajan, MD, MHS, FAAN

Abhimanyu Mahajan, MD, MHS, FAAN

Parkinson's disease | Movement Disorders

Hypotension in PDD and DLB

Is hypotension the mechanism behind cognitive fluctuations in Parkinson's disease dementia and dementia with Lewy Bodies? The aim of the study is tp determine if the cortical electroencephalographic signatures of cognitive fluctuations are present in PDD and DLB patients with OH. We will use a tilt table test to determine if PDD/DLB patients with OH may have a differential electroencephalographic pattern than those without OH. Hypothesis: PDD and DLB patients with OH will have dominant frequency variability between alpha (8.0-12.0 Hz) and pre-alpha (5.5-7.5 Hz) bands compared with patients without OH.

Michael D. Privitera, MD

Epilepsy

Phase 2

BHV7000 for Focal Epilepsy Study

This is a randomized, placebo-controlled trial testing BHV-7000 in adults with focal onset epilepsy that has not been controlled by prior medicines. The study has two parts. In Part A participants are randomly assigned to 25 mg, 50 mg of BHV-7000, or placebo. After Part A, Part B will begin and will randomly assign participants to 75 mg BHV-7000 or placebo. Participants continue their usual anti-seizure medicines and record seizures during an 8-week observation phase, then receive 12 weeks of double-blind treatment. The main goal is to see whether BHV-7000 reduces 28-day average seizure frequency compared with baseline and to measure safety by tracking adverse events and lab abnormalities. Other goals include responder rates (50% and 75% seizure reduction), seizure freedom, early treatment effects (first week and first month), and patient global impression of change.

Learn More about BHV7000 for Focal Epilepsy Study
Lawrence Goldstick, MD

Lawrence Goldstick, MD

Multiple Sclerosis

Phase 3

Frexalimab Versus Teriflunomide in MS

This is a pair of Phase 3, randomized, double-blind studies comparing an investigational antibody called frexalimab to the approved oral drug teriflunomide in adults with relapsing multiple sclerosis (ages 18-55). Each study measures how often participants have relapses over the study period (annualized relapse rate) and follows safety, disability changes, MRI lesion counts, brain volume, cognitive tests, and blood markers. The studies are event-driven: every participant will be treated at least 12 months, and many will be followed up to about 156 weeks (three years). Visits are every 4 weeks for the first 6 months, then every 3 months, with an end-of-study visit and three follow-up visits. Safety monitoring includes tracking adverse events, lab tests, ECGs, and antibodies to the drug. The goal is to see if frexalimab reduces relapses and is safe compared with teriflunomide.

Learn More about Frexalimab Versus Teriflunomide in MS
Hani Kushlaf, MD

Hani Kushlaf, MD

Neuromuscular

Pompe Disease Patient Registry

This is a global, prospective registry that follows people with Pompe disease over time. The registry includes those with infantile-onset and late-onset forms, and it accepts both people who are receiving approved Pompe therapies and those who are not receiving treatment. The main goals are to track long-term safety by collecting reports of adverse events, measure real-world effectiveness of treatments, understand impacts on quality of life through patient-reported outcomes, and describe the natural course of untreated Pompe disease. Participants' medical information is collected during routine care visits and at enrollment. People currently enrolled in clinical trials or receiving investigational therapies for Pompe disease are not eligible. The registry is observational, so no experimental treatments are given as part of the study.

Learn More about Pompe Disease Patient Registry
Robert Stanton, MD

Robert Stanton, MD

Subacute

Anticoagulation in ICH Survivors

The Anticoagulation in Intracerebral Hemorrhage Survivors for Stroke and recovery study is a randomized, double-blinded, phase III clinical trial designed to test the efficacy and safety of anticoagulation, compared with aspirin, in patients with a recent ICH and high risk non valvular AF. A total of 700 patients, age 18 or older with a first ever ICH 14-120 days before entry will be randomized in a 1:1 ratio to receive apixaban ( 5 mg tablet twice daily or 2.5 mg tablets twice daily for patients meeting standard dose adjustment requirements) or aspirin (81 mg tablet once daily).

Learn More about Anticoagulation in ICH Survivors
513-558-3072
Stacie Demel, DO, PhD

Stacie Demel, DO, PhD

Subacute

Stroke Cognitive Recovery Study

This is a large, observational study that will enroll about 8,000 people who are hospitalized with a recent stroke and who do not have known dementia. The study looks at how thinking and memory change after stroke and what factors influence recovery. All participants complete a baseline check, blood sample, and short thinking and daily function tests. They have follow up visits in person at about 3 to 6 months and 18 months, and yearly phone check ups up to four years. Some participants join extra tiers that include brain MRI scans and more detailed thinking tests and blood draws. A smaller group gets special PET scans that look for proteins linked to dementia. The study follows people over time to learn which stroke features, imaging findings, blood markers, and other risks lead to more or less cognitive decline.

Learn More about Stroke Cognitive Recovery Study

Michael D. Privitera, MD

Epilepsy

Testing a wearable device for seizures

This study tests a wearable device that tracks seizures, heart rhythm, breathing, and oxygen levels while people are already in the hospital for epilepsy monitoring. Participants wear the devices during their hospital stay. The information collected may help improve future seizure detection devices.

Hani Kushlaf, MD

Hani Kushlaf, MD

Neuromuscular

Phase 3

Empasiprubart versus IVIg in CIDP

This Phase 3 study compares an investigational drug called empasiprubart with standard intravenous immunoglobulin (IVIg) in adults who have CIDP and who have previously responded to IVIg. In Part A (24 weeks) participants are randomly assigned in a double blind way to receive either empasiprubart plus a placebo that looks like IVIg or IVIg plus a placebo that looks like empasiprubart. After finishing Part A, all participants may enter Part B and receive empasiprubart for up to 96 weeks. The main goal is to see whether patients improve by at least one point on a disability scale (aINCAT) at week 24. The study also tracks strength, grip, walking time, patient reported quality of life and fatigue, work impact, antibody responses to the study drug, drug levels in the blood, and any side effects over the full study period.

Learn More about Empasiprubart versus IVIg in CIDP
Luca Marsili, MD

Luca Marsili, MD

Movement Disorders

Tracking Brain Side Effects of CAR-T Therapy

Adults receiving CAR-T therapy will complete handwriting and thinking tests before and after treatment. Researchers look for early signs of brain side effects.

Rhonna Shatz, DO

Rhonna Shatz, DO

Memory Disorders

Alzheimer's National Registry for Treatment and Diagnostics

The ALZ-NET study is establishing a national registry to collect ongoing clinical and safety information for patients being evaluated for or treated with new FDA-approved therapies for Alzheimer's disease. This effort will help track how well these treatments work over time and their safety outcomes in everyday medical settings. Participating doctors and staff will receive training to ensure accurate data collection. By gathering a wide range of information, including cognitive and safety data as well as genetic and imaging biomarkers, ALZ-NET aims to improve care and support innovative research. They also plan to store biological samples and brain images from consenting participants. The study is open to adults 18 and older who are either considering, starting, or currently on new Alzheimer's treatments.

Learn More about Alzheimer's National Registry for Treatment and Diagnostics
Alberto Espay, MD

Alberto Espay, MD

Parkinson's disease | Movement Disorders

TQR-84 (Placebo Study)

Patients will be told they are receiving either a novel medication (TQR-84) or placebo. However, all participants will receive IR-CD/LD. We will evaluate the differences on motor improvement after levodopa introduction, as measured by the motor subscale of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS-III),13 between a positive framework (to enhance expectations) compared to a neutral framework (to dampen expectations).

513-558-0505
Aram Zabeti, MD

Aram Zabeti, MD

Multiple Sclerosis

Stem Cell Transplant V/S BAT Therapy

This is a Randomized study to compare the efficacy, safety, immunologic effects, and cost-effectiveness of myeloablative and immunoablative therapy followed by autologous hematopoietic stem cell transplant (AHSCT) versus best available therapy (BAT) over 72 months in participants with relapsing MS and continued MS disease activity despite treatment with DMTs.

Learn More about Stem Cell Transplant V/S BAT Therapy
Hani Kushlaf, MD

Hani Kushlaf, MD

Neuromuscular

Phase 3

Placebo-controlled trial in Generalized Myasthenia Gravis

The purpose of this study is to evaluate the efficacy, safety and tolerability of remibrutinib in patients with generalized Myasthenia Gravis (gMG) who are acetylcholine receptor positive (AChR+), muscle-specific tyrosine kinase positive (MuSK+), or double-seronegative (AChR- and MuSK-) who are on stable, standard-of-care (SOC) treatment. The study aims to evaluate whether treatment with remibrutinib will result in the reduction of the total score in Myasthenia Gravis Activity of Daily Living (MG-ADL) scale as compared to placebo.

Learn More about Placebo-controlled trial in Generalized Myasthenia Gravis
Wole Awosika, MD

Wole Awosika, MD

Subacute

Phase 3

Home Telerehab After Stroke

This study tests whether adding a home telerehabilitation program to usual post-stroke care improves arm movement and overall ability after a stroke. People who had a stroke about 4 months earlier and have moderate weakness in one arm are randomly placed into one of two groups: (1) telerehabilitation plus usual care, or (2) usual care alone. The telerehab program includes 36 remote training sessions made of exercises, interactive games, and stroke education that total 70 minutes per day, six days a week, for about 6 weeks. Participants stay in the study for about 8 months and come to four in-person visits for arm tests and one brain MRI. The main goal is to see if arm function improves more at 2 months in the telerehab group, and a secondary goal is to see if overall disability is reduced. People in the usual care group are offered the telerehab program after the study ends.

Learn More about Home Telerehab After Stroke
Aram Zabeti, MD

Aram Zabeti, MD

Multiple Sclerosis

Phase 4

Early Intensive v/s Escalation Tx

This is an open-label, rater unblinded, randomized clinical trial. Participants will be randomized in a 1:1 ratio to an EHT approach as first-line (alemtuzumab, natalizumab, rituximab, ocrelizumab, or ofatumumab at clinician and participant discretion), or escalation approach (any approved DMT except alemtuzumab, natalizumab, rituximab, ocrelizumab, or ofatumumab as first-line with or without subsequent escalation to any approved DMT).

Learn More about Early Intensive v/s Escalation Tx
513-907-6459
Robert Stanton, MD

Robert Stanton, MD

Subacute

Statins After Lobar Brain Bleed

This is a large randomized trial testing whether people who were taking a statin when they had a spontaneous lobar brain bleed should continue the statin or stop it. About 1,456 patients who can be randomized within 7 days of their bleed will be assigned to either continue the same statin and dose or to stop it for up to 24 months. All patients will have testing for APOE gene type and will be followed for 24 months to see if they have another symptomatic brain bleed or other major heart/brain events. An optional MRI study in some participants will look at brain small vessel disease markers at the start and end of follow-up to see how statins affect those MRI findings. The study is run at many sites in the U.S. and Canada.

Learn More about Statins After Lobar Brain Bleed
Emily Hill, MD

Emily Hill, MD

Parkinson's disease

PD GENEration Genetic Registry

This study collects genetic test results and leftover DNA from people with Parkinson's to build a central, secure resource for future research. Adults who have a probable Parkinson's diagnosis and agree to genetic testing can join. Participants allow their data to be stored for research and can choose to be told their results for several PD-related genes. The study also provides genetic counseling so people can understand what their results mean. It is an observational, one-time study (cross-sectional) meant to find how common certain gene changes are and to help researchers studying Parkinson's. There is no drug or treatment given; the study involves surveys, genetic testing, and storing DNA for future studies.

Learn More about PD GENEration Genetic Registry
Laura Ngwenya, MD, PhD

Laura Ngwenya, MD, PhD

Neurotrauma | Neuro-critical care

Using Eye Ultrasound to Monitor Brain Pressure After Brain Injury

This research is studying whether ultrasound scans of the eye can help doctors detect and monitor changes in pressure inside the brain. Adults with a brain injury who are already receiving standard brain pressure monitoring in the hospital may be eligible. During the study, a trained operator places ultrasound gel on the closed eyelid and gently performs eye ultrasound scans. Scans may be repeated over several days while participants remain in the hospital and receive their usual medical care. Researchers will compare the ultrasound measurements with information from standard brain pressure monitoring and medical imaging. The goal is to improve ultrasound technology and develop computer-assisted tools that may help healthcare providers identify changes in brain pressure more quickly in future patients.

Hani Kushlaf, MD

Hani Kushlaf, MD

Neuromuscular

Phase 3

Oral Cladribine in Generalized MG

This is a Phase 3 study testing a new oral form of cladribine in adults with generalized myasthenia gravis (gMG). Participants are randomly assigned to receive the new cladribine or placebo during a 24 week double blind period. The study then continues into two extension periods to see how long benefits last, whether people need retreatment, and to monitor long term safety. The main measure is change in daily function using the MG-ADL score at 24 weeks. Other measures include muscle strength scores, quality of life, time to first retreatment, safety events, lab tests (including lymphocyte counts), and drug levels in the blood. People must have stable MG symptoms and medications before joining. Important exclusions include other immune or neuromuscular diseases, active infections, cancer, recent use of many other immune drugs, prior cladribine use, and lack of varicella immunity. The study aims to show whether oral cladribine can safely reduce MG symptoms and how long the effect lasts.

Learn More about Oral Cladribine in Generalized MG
Lawrence Goldstick, MD

Lawrence Goldstick, MD

Multiple Sclerosis

Phase 3

Remibrutinib in SPMS Study

This is a Phase III randomized, double-blind, placebo-controlled study testing remibrutinib in adults with secondary progressive multiple sclerosis (SPMS). About 1,275 eligible participants will be randomly assigned to take remibrutinib or a matching placebo. The main goal is to find out whether remibrutinib can slow confirmed worsening of disability over time, measured mainly by a standard disability scale (EDSS) over an event-driven period of up to about five years. The study will also track shorter-term disability changes, walking and hand function, cognitive speed, MRI measures (new or enlarging lesions and brain volume loss), and safety events. After the double-blind core part, participants may join an open-label extension where they can receive remibrutinib. Screening and regular assessment visits will include exams, MRI scans, safety lab tests, and functional tests.

Learn More about Remibrutinib in SPMS Study
Hani Kushlaf, MD

Hani Kushlaf, MD

Neuromuscular

Phase 3

Riliprubart vs IVIg in CIDP

This is a Phase 3 study that compares an experimental biologic called riliprubart to standard intravenous immunoglobulin (IVIg) in adults who have chronic inflammatory demyelinating polyneuropathy (CIDP) and are already on regular IVIg. The study has two parts: a double blind randomized phase (Part A) where participants get either riliprubart or continue IVIg, and an open label extension (Part B) where treatments are known. The main goal is to see how many people improve in disability score (INCAT) by at least 1 point at 24 weeks. The study also looks at many other outcomes such as muscle strength, fatigue, quality of life, relapses, safety events, and whether the body makes anti‑drug antibodies. People must have shown benefit from IVIg before, have ongoing CIDP-related disability, meet vaccination and contraception rules, and meet other health criteria. The whole study, including screening, treatment, and follow up, can last up to 109 weeks. Safety is monitored through reported side effects, lab tests, and antibody testing.

Learn More about Riliprubart vs IVIg in CIDP
Hani Kushlaf, MD

Hani Kushlaf, MD

Neuromuscular

Phase 4

Pompe Disease registry

The Pompe Registry is a global, multicenter, international, longitudinal, observational, and voluntary program for patients with Pompe disease, designed to track the disease's natural history and outcomes in patients, both treated and not.

Learn More about Pompe Disease registry
Robert McNamara, PhD

Robert McNamara, PhD

Cognitive Aging | Memory Disorders

Optimizing CNS DHA Delivery

This is a 24-week, randomized, placebo-controlled study testing two forms of DHA (an omega-3 fat) in older adults who have early signs of memory or thinking problems. Participants will be randomly assigned to receive LPC-DHA (a form thought to enter the brain more easily), TAG-DHA (standard triglyceride DHA), or placebo. The main goal is to see which form raises DHA levels in the cerebrospinal fluid (CSF). The study also measures blood and CSF markers linked to brain degeneration and growth (such as amyloid-beta, phospho-tau217, and BDNF), genetic risk (APOE), and tests of memory and executive function at baseline, 12 weeks, and 24 weeks. Some participants will have lumbar punctures to collect CSF. The study will compare how each treatment changes DHA and other markers and whether changes in CSF DHA relate to improvements on memory and thinking tests.

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513-558-6831
Yasmin N. Aziz, MD

Yasmin N. Aziz, MD

Subacute

CAPTIVA MRI Biomarker Study

This is an observational MRI study done alongside the CAPTIVA clinical trial. People already enrolled in CAPTIVA who had a recent non-disabling stroke from severe narrowing (70-99%) of an intracranial artery can join. Participants get a detailed MRI scan within 14 days of CAPTIVA enrollment to look at artery plaque and blood flow. The study will follow participants for about 12 months to see if MRI features can help predict who will have another ischemic stroke in the same artery despite medical therapy. The goal is to find imaging markers that could guide future trials and improve care for patients with intracranial artery narrowing.

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Aram Zabeti, MD

Aram Zabeti, MD

Neuro-Immunology

INEBILIZUMAB IN ANTI-NMDA ENCEPHALITIS

There are currently no medicinal products approved for the treatment of anti-N-methyl-D-aspartate receptor (NMDAR) encephalitis, a rare disease. NMDAR encephalitis is a life-threatening, antibody-mediated autoimmune disorder of the central nervous system. Standard of care includes high-dose corticosteroids AND either intravenous immunoglobulin (IVIg) OR plasmapheresis. However, as many as 47% of patients may fail to respond to initial treatment at 4 weeks; thus, there is a high unmet medical need for more effective therapies. The pathogenesis of NMDAR encephalitis suggests that B cell depletion may be an effective avenue for therapeutic intervention. The anti-CD19 B cell-depleting activity of inebilizumab suggests that it may provide benefit as treatment for NMDAR encephalitis. This study aims to define the efficacy and safety of inebilizumab in reducing the level of disability in patients with NMDAR encephalitis as measured by modified Rankin score (mRS). If you think that you might have a potential participant contact the ExTINGUISH hotline 844-4BRAIN5 (844-427-2465)

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513-252-8890
Aram Zabeti, MD

Aram Zabeti, MD

Multiple Sclerosis

Phase 3

Studying a Switch in Treatment for Relapsing Multiple Sclerosis

This study is testing whether a daily oral medicine called remibrutinib works as well as the current treatment, ocrelizumab, for people with relapsing multiple sclerosis. People who have been on ocrelizumab for at least 18 months and are between 40 and 70 years old may join. The study will look at how MS changes over time using MRI scans, physical tests, and symptom reports. Participants may receive remibrutinib or continue ocrelizumab for up to two years, and those who finish this part may continue on remibrutinib for another two years. The study aims to learn whether switching to remibrutinib is safe, effective, and easier for patients.

Aram Zabeti, MD

Aram Zabeti, MD

Multiple Sclerosis

Phase 4

SPHERES Registry for NMOSD

This is a long-term, forward-looking registry for adults with NMOSD who are under a neurologist's care at UC Health. People who join will have their medical information, treatment use, relapses, and patient-reported outcomes collected on a regular basis. The goal is to learn how NMOSD starts and changes over time, to see how treatments work and how safe they are in everyday care, and to better understand the effects on daily life and costs. The registry may link a person's data to other public or private databases (with consent) to allow more research on health care use, costs, and treatment adherence. Participants may be asked to complete extra short surveys from time to time, for example about caregiver burden or work impact. No study drug is given; this is an observational study focused on collecting real-world data.

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Hani Kushlaf, MD

Hani Kushlaf, MD

Neuromuscular

Phase 3

Weekly Subcutaneous injection of Telitacicept vs. placebo

This Phase 3 study tests telitacicept, a medicine given to lower immune activity from certain B cells, in people with generalized myasthenia gravis (gMG). gMG causes muscle weakness that usually gets worse with use. Adults with confirmed gMG and positive antibodies will be randomly given telitacicept or a placebo without knowing which they get for the first 24 weeks. The main goal is to see if daily-life symptoms improve after 24 weeks. Other goals include measuring muscle strength and quality of life. Safety will be monitored. After the 24-week blinded part, people can join an open-label extension to receive telitacicept and continue follow-up. The study aims to find out if telitacicept helps reduce weakness and is safe for people with gMG.

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Robert Stanton, MD

Robert Stanton, MD

Subacute

Apixaban versus Aspirin After ICH

This is a Phase 3, randomized, double-blind study that compares the blood thinner apixaban to aspirin in people who had a recent brain bleed (intracerebral hemorrhage) and also have atrial fibrillation. The study will enroll about 700 people and follow each person for at least 12 months and up to 36 months. The main question is whether apixaban lowers the chance of any stroke (either a new bleed or a clot-related stroke) or death from any cause compared with aspirin. The study also looks at whether people do better in recovery and daily function. Patients are enrolled 14 to 180 days after their brain bleed. The trial is taking place at multiple sites coordinated through a stroke research network.

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Hani Kushlaf, MD

Hani Kushlaf, MD

Neuromuscular

Phase 3

Subcutaneous weekly injection by autoinjector for Generalized Myasthenia gravis

Study IMVT-1402-3101 is a Phase 3, multicenter, randomized, placebo-controlled, double-blind study to assess the efficacy, safety and tolerability, PK, and PD of IMVT-1402 in participants 18 to 80 years old inclusive who have mild to severe gMG. Eligible participants will be randomized in a 1:1:1 ratio to receive blinded IMVT-1402 600 mg subcutaneous (SC) once weekly (QW), IMVT-1402 300 mg SC QW, or placebo SC QW for 12 weeks during Period 1

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Michael D. Privitera, MD

Epilepsy

FORETELL: How Daily Patterns and Wearables May Help Forecast Seizures

The FORETELL Study wants to learn whether everyday patterns can help people know when a seizure might be more likely. Participants use a phone app to check in each day and answer simple questions about their sleep, stress, mood, and any seizures they had. They also wear a smartwatch that tracks things like heart rate, sleep quality, and activity. Some people will give small saliva samples so the research team can look at natural stress levels. By combining information from the app, the watch, and the saliva samples, the study hopes to find patterns that could give early clues about when a seizure might happen. The goal is to help people living with epilepsy better understand their own patterns and feel more prepared in their daily lives. No treatments are being tested, and participants continue their usual medical care throughout the study.

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