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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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).

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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
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