Clinical Trials

CIViC-19 (COVID-19 study) 

• What kind of research is this? A study of how the immune system responds to the virus that causes COVID-19 and how the virus might change during the course of an infection 
• Who is this for? Patients from birth to 90 years old who are Positive for COVID-19, the household contacts of enrolled subjects, and control group patients who are negative COVID-19  
• Who is the doctor in charge of this study? Heather Smallwood, PhD  

Status: We are currently looking for patients for this study 

If you are interested in enrolling or would like more information, please contact the study coordinator: Ashley Blair, 901.634.6342, CIVIC19study@live.utk.edu.  

Aztreonam and Avibactam (ATM-AVI) for Infections

• What kind of research is this? This study looks at how of Aztreonam-Avibactam (ATM-AVI) works for pediatric patients with infection.
• Who is this for? Pediatric patients aged 9 months to 18 years of age who are hospitalized with a suspected or confirmed complicated gram-negative infection(s) and receiving intravenous antibiotics; areas of infection include the abdomen, urinary tract, blood stream, and lungs.
• Who is the doctor in charge of this study? Maria Carrillo-Marquez, MD

If you are interested in enrolling or would like more information, please contact the study coordinator: Katie Ryan, 901-287-5425, kathryn.ryan@lebonheur.org.

ClinicalTrials.gov information:

• Official Name: Study of 2 Medicines (Aztreonam and Avibactam) Compared to Best Available Therapy for Serious Gram-negative Infections
• Identifier: NCT05639647 (https://clinicaltrials.gov/study/NCT05639647)

Congenital CMV Biomarker Study

• What kind of research is this? This study will find out test results can be used to determine how hearing will be impacted in babies with a congenital cytomegalovirus (CMV) infection
• Who is this for? Infants 0 to 55 days old
• Who is the doctor in charge of this study? Maria Carrillo-Marquez, MD

If you are interested in enrolling or would like more information, please contact the study coordinator: Kara Lessel, 901.287.4594, kara.lessel@mlh.org.

Amplitude Integrate Electroencephalogram (aEEG) in Newborns Exposed to Prenatal Illicit Substances  

• What kind of research is this? A study of how well a test called an amplitude integrate electroencephalogram (aEEG) works in newborns who were exposed to illicit substances before birth 
• Who is this for? All infants and their mothers admitted to The Newborn Center’s well baby nursery (WBN) or neonatal intensive care unit (NICU); mothers have a history of prescription substance use during pregnancy 
• Who is the doctor in charge of this study? Divya Rana, MD  

Status: We are currently looking for patients for this study 

If you are interested in enrolling or would like more information, please contact the study coordinator: Gail Camp, 901.448.1823, lcamp@uthsc.edu.   

AMPLITUDE Study  

• What kind of research is this? A study of a new medicine called of VX-147 for patients with a type of kidney disease called apolipoprotein L1 (APOL1)-mediated proteinuric kidney disease.
• Who is this for? Children 10 years old and older who have proteinuric kidney disease.
• Who is the doctor in charge of this study? Rima Zahr, DO

Status: We are currently looking for patients for this study.

If you are interested in enrolling or would like more information, please contact the study coordinator: Teresa Berkley, 901.287.5179, teresa.berkley@lebonheur.org.

ClinicalTrials.gov information:

• Official Name: Phase 2/​3 Adaptive Study of VX-147 in Adult and Pediatric Participants With APOL1- Mediated Proteinuric Kidney Disease (AMPLITUDE)
• Identifier: NCT05312879 (https://beta.clinicaltrials.gov/study/NCT05312879)

Official study website: https://amplitudestudy.com/

AbbVie Study of Atogepant for Migraines

• What kind of research is this? · What kind of research is this? A study to use a new medicine called Atogepant to treat children and adolescents who suffer from episodic migraine headaches
• Who is this for? Children and adolescents 6 to 17 years of age who have a history and diagnosis of consistent migraine with or without aura for at least 6 months
• Who is the doctor in charge of this study? Ankita Ghosh, MD

Status: We are currently looking for patients for this study.

If you are interested in enrolling or would like more information, please contact the study coordinator: John Franklin, 901.287.4473, john.franklin@lebonheur.org.

ClinicalTrials.gov information:

• Official Name: A Study to Assess the Adverse Events and Change in Disease Activity of Oral Atogepant Tablets in Pediatric Participants (6-17 Years of Age) With Episodic Migraine (ATO EM PEDS)
• Identifier: NCT05711394 (https://clinicaltrials.gov/study/NCT05711394)

Biohaven Pharmaceuticals Study of Rimegepant for Migraines

• What kind of research is this? A study to use a new medicine called Rimegepant to treat children and adolescents who suffer from migraine headaches
• Who is this for? Children between 6 to 18 years old who have a history of migraine headaches. The migraines can either be with or without aura
• Who is the doctor in charge of this study? Ankita Ghosh, MD

Status: We are currently looking for patients for this study.

If you are interested in enrolling or would like more information, please contact the study coordinator: John Franklin, 901.287.4473, john.franklin@lebonheur.org.

EpiCom Study

• What kind of research is this? This study will look at using a medication called Epidiolex as an add-on medicine for children and adults with tuberous sclerosis complex (TSC) and seizures.
• Who is this for? Infants and children from 1 year old to adults 65 years old
• Who is the doctor in charge of this study? Sarah Weatherspoon, MD

Status: We are currently looking for patients for this study.

If you are interested in enrolling or would like more information, please contact the study coordinator: Misha Webb, 901.287.5330, misha.webb@lebonheur.org.

ClinicalTrials.gov information:  

• Official Name: A Study to Investigate Behavioral and Other Co-Occurring Outcomes With Epidiolex as Add-On Therapy in Participants Aged 1 to 65 Years of Age With Tuberous Sclerosis Complex (EpiCom)
• Identifier: NCT05864846 (https://clinicaltrials.gov/study/NCT05864846)

Functional brain mapping using transcranial magnetic stimulation  

• What kind of research is this? A study of a test called functional brain mapping that uses a a procedure called transcranial magnetic stimulation (TMS) to look for brain changed in people with neurological or psychological disorders 
• Who is this for? Children and adolescents 3 and 17 years old with a neurological or psychological disorder and healthy volunteers without neurological or psychological disorders and  
• Who is the doctor in charge of this study? Shalini Narayana, PhD  

Status: We are currently looking for patients for this study 

If you are interested in enrolling or would like more information, please contact Dr. Shalini Narayana, 901.287.4616, snaraya2@uthsc.edu.  

Human Tissue Study 

• What kind of research is this? A study to test for changes in proteins and genes in tissue samples from the brain taken during epilepsy surgery 
• Who is this for? Children between 4 and 13 years old with epilepsy and who will undergo epilepsy surgery 
• Who is the doctor in charge of this study? James Wheless, MD 

Status: We are currently looking for patients for this study 

If you are interested in enrolling or would like more information, please contact the study coordinator: Kenishia Guy, 901.287.7484, Kenishia.Guy@lebonheur.org.  

International Pediatric Stroke Study (IPSS) 

• What kind of research is this? A registry of data to be collected from children across the world who are at high risk for stroke or who have already had a stroke 
• Who is this for? Children from birth to 18 years old who have been diagnosed with stroke or a condition or disease that may put them at a high risk of stroke  
• Who is the doctor in charge of this study? Tracee Ridley-Pryor, DNP, APRN, PMHNP-BC  

Status: We are currently looking for patients for this study 

If you are interested in enrolling or would like more information, please contact the study coordinator: John Franklin, 901.287.4473, john.franklin@lebonheur.org.  

Kaleidoscope Migraine Study

• What kind of research is this? A study to use a new medicine called Atogepant to treat children and adolescents who suffer from episodic migraine headaches
• Who is this for? Children and adolescents 6 to 17 years of age who have a history and diagnosis of consistent migraine with or without aura for at least 6 months and who have completed the initial AbbVie Study of Atogepant for migraines (ClinicalTrials.gov Identifier: NCT05711394)  
• Who is the doctor in charge of this study? Ankita Ghosh, MD

Status: We are currently looking for patients for this study.

If you are interested in enrolling or would like more information, please contact the study coordinator: John Franklin, 901.287.4473, john.franklin@lebonheur.org.  

ClinicalTrials.gov information:

• Official Name: Long-term Extension Study to Assess Adverse Events of Oral Atogepant Tablets in Pediatric Participants (6 to 17 Years of Age) With Migraine (Kaleidoscope)
• Identifier: NCT05707949 (https://clinicaltrials.gov/study/NCT05707949)

Low-Frequency TMS Treatment for Refractory Complex Partial Epilepsy  

• What kind of research is this? A study of a test called low-frequency transcranial magnetic stimulation (TMS) for detecting complex partial epilepsy 
• Who is this for? Patients who are 5 years old or older who have epilepsy that is difficult to treat (refectory epilepsy) with patients seizures (seizures that affect only a part of the brain) 
• Who is the doctor in charge of this study? Shalini Narayana, PhD 

Status: We are currently looking for patients for this study 

If you are interested in enrolling or would like more information, please contact Dr. Shalini Narayana, 901.287.4616, snaraya2@uthsc.edu.  

Nelli - Detection of Paroxysmal Events Utilizing Computer Vision and Machine Learning

• What kind of research is this? A study to use machine learning to teach a system named Nelli how to detect seizures from video recordings of patients before they occur  
• Who is this for? Children and adolescents 6 and 21 years old who have a history (or a suspected history) of seizures who are scheduled to undergo routine video-EEG monitoring 
• Who is the doctor in charge of this study? James Wheless, MD  

Status: We are currently looking for patients for this study 

If you are interested in enrolling or would like more information, please contact the study coordinator: Crystal Baez Cervantes, 901.287.5649, crystal.baezcervantes@lebonheur.org.   

Novel Side Positioner Vest Device Trial  

• What kind of research is this? A study of a vest that can be used for positioning infants on their side to prevent or treat head flattening (occipital plagiocephaly) 
• Who is this for? Healthy infants 1 to 10 months of age 
• Who is the doctor in charge of this study? Stephanie Einhaus, MD  

Status: We are currently looking for patients for this study 

If you are interested in enrolling or would like more information, please contact the study coordinator: Brandy Vaughn, 901.287.5892, brandy.vaughn@lebonheur.org. 

ORCHID Study

• What kind of research is this? A study to use a new medication called Fenfluramine to treat children and adolescents who have Dravet syndrome
• Who is this for?Infants between 1 to 2 years old 
• Who is the doctor in charge of this study? James Wheless, MD 

Status: We are currently looking for patients for this study.

If you are interested in enrolling or would like more information, please contact the study coordinator: Kenishia Guy, 901.287.7484, Kenishia.Guy@lebonheur.org.

ClinicalTrials.gov information:  

• Official Name: A Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Fenfluramine (Hydrochloride) in Infants 1 Year to Less Than 2 Years of Age With Dravet Syndrome (ORCHID)
• Identifier: NCT02744677 (https://clinicaltrials.gov/study/NCT06118255) 

Pharmacokinetics Study of VALTOCO® in Pediatric Subjects With Epilepsy 

• What kind of research is this? A study of a medicine called Valtoco for treating epilepsy 
• Who is this for? Children 2 to 5 years old with a clinical diagnosis of epilepsy 
• Who is the doctor in charge of this study? James Wheless, MD 

Status: Active not recruiting

If you are interested in enrolling or would like more information, please contact the study coordinator: Misha Webb, 901.287.5330, Misha.Webb@lebonheur.org.  

ClinicalTrials.gov information:  

• Official Name: Pharmacokinetics Study of VALTOCO® in Pediatric Subjects With Epilepsy 
• Identifier: NCT05076838 (https://beta.clinicaltrials.gov/study/NCT05076838)

Seizures and Children’s Outcomes After Stroke (SCOUTS)

• What kind of research is this? This study will look at brain injuries that infants, children, and adolescents suffer after a stroke that may lead to developing seizures in the short term and epilepsy in the long term
• Who is this for? Patients who experienced a stroke between 28 days of age and 18 years of age who were enrolled in the Vascular Effects of Infection in Pediatric Stroke (VIPS) I or II studies
• Who is the doctor in charge of this study? Beth Anne Cavanaugh, MD

Status: We are currently looking for patients for this study

If you are interested in enrolling or would like more information, please contact the study coordinator: John Franklin, 901.287.4473, john.franklin@lebonheur.org.

Skip 039 

• What kind of research is this? A study of a medicine called Cenobamate for treating partial-onset (or focal) seizures 
• Who is this for? Children and adolescents 2 to 18 years old with partial-onset seizures 
• Who is the doctor in charge of this study? James Wheless, MD 

Status: We are currently looking for patients for this study 

If you are interested in enrolling or would like more information, please contact the study coordinator: Misha Webb, 901.287.5330, Misha.Webb@lebonheur.org.  

ClinicalTrials.gov information:  

• Official Name: Safety and Efficacy Extension Study of Cenobamate in Pediatric Subjects 2-17 Years of Age With Partial-onset (Focal) Seizures 
• Identifier: NCT05067634 (https://beta.clinicaltrials.gov/study/NCT05067634)  

Skip 040 

• What kind of research is this? A study of a medicine called Cenobamate for treating partial-onset (or focal) seizures 
• Who is this for? Children and adolescents 2 to 18 years old with partial-onset seizures 
• Who is the doctor in charge of this study? James Wheless, MD 

Status: We are currently looking for patients for this study 

If you are interested in enrolling or would like more information, please contact the study coordinator: Misha Webb, 901.287.5330, Misha.Webb@lebonheur.org.  

Swallowtail (Stoke Therapeutics) 

• What kind of research is this? A study of a medicine called STK-001 to treat Dravet Syndrome 
• Who is this for? Children 2-and-a-half years old and older who have Dravet Syndrome and who participated in a previous study of STK-001 
• Who is the doctor in charge of this study? James Wheless, MD 

Status: Active not recruiting

ClinicalTrials.gov information:  

• Official Name: An Open-Label Extension Study of STK-001 for Patients With Dravet Syndrome 
• Identifier: NCT04740476 (https://beta.clinicaltrials.gov/study/NCT04740476)  

UCB EP0162 

• What kind of research is this? A study of a medicine called Alprazolam for patients with stereotypical prolonged seizures 
• Who is this for? Adolescents 12 years old or older who have stereotypical prolonged seizures 
• Who is the doctor in charge of this study? Basanagoud Mudigoudar, MD  

Status: We are currently looking for patients for this study 

If you are interested in enrolling or would like more information, please contact the study coordinator: Kenishia Guy, 901.287.7484, Kenishia.Guy@lebonheur.org.  

ClinicalTrials.gov information:  

• Official Name: A Study to Test the Efficacy and Safety of Staccato Alprazolam in Study Participants 12 Years of Age and Older With Stereotypical Prolonged Seizures 
• Identifier: NCT05077904 (https://beta.clinicaltrials.gov/study/NCT05077904)  

UCB EP0165  

• What kind of research is this? A study of a medicine called Alprazolam for patients with stereotypical prolonged seizures 
• Who is this for? Adolescents 12 years old or older who have stereotypical prolonged seizures 
• Who is the doctor in charge of this study? Basanagoud Mudigoudar, MD 

Status: We are currently looking for patients for this study 

If you are interested in enrolling or would like more information, please contact the study coordinator: Kenishia Guy, 901.287.7484, Kenishia.Guy@lebonheur.org.  

Zogenix 2103  

• What kind of research is this? A study of a medicine called Zx008 to treat a genetic illness called Cdkl5 Deficiency Disorder (CDD) 
• Who is this for? Child and adult patients from 1 to 35 years old with a likely or confirmed mutation in the CDKL5 gene and a clinical diagnosis of CDD; patients will also need to have experienced epilepsy onset in the first year of life with motor and 
• developmental delays 
• Who is the doctor in charge of this study? James Wheless, MD  

Status: We are currently looking for patients for this study 

If you are interested in enrolling or would like more information, please contact the study coordinator: Kenishia Guy, 901.287.7484, Kenishia.Guy@lebonheur.org.  

ClinicalTrials.gov information:  

• Official Name: A Study to Investigate the Efficacy and Safety of ZX008 in Subjects With CDKL5 Deficiency Disorder 
• Identifier: NCT05064878 (https://beta.clinicaltrials.gov/study/NCT05064878) 

Physical Activity as a Vital Sign in Mid-South Youth

• What kind of research is this? A study to use physical activity to monitor and improve physical and mental health and prevent chronic diseases like diabetes in adulthood.

• Who is this for? Any child between 6 to 18 years old who has come to Le Bonheur for a non-emergency medical issue; the child must be able to answer questions in a questionnaire and participate in physical activity.

• Who is the doctor in charge of this study? Webb Smith, PhD

Status: We are currently looking for patients for this study 

If you are interested in enrolling or would like more information, please contact the study coordinator: Savannah Blackwell, 901.287.6869, sblackw8@uthsc.edu.

Bracing vs Casting in the Treatment of Idiopathic Early-Onset Scoliosis  

• What kind of research is this? A study to compare casting and bracing for treating idiopathic early onset scoliosis (IEOS) 
• Who is this for? Children with a diagnosis of idiopathic early-onset scoliosis 
• Who is the doctor in charge of this study? Derek Kelly, MD  

Status: Active, not recruiting

If you are interested in enrolling or would like more information, please contact the study coordinator: Jonathan Rowland, 901.287.6856, Jonathan.Rowland@lebonheur.org.  

Does the Use of Complementary Alternative Medicine in Adolescents with Idiopathic Scoliosis Undergoing Posterior Spinal Fusion Improve Patient Outcomes? 

• What kind of research is this? A study of a natural supplement (aromatherapy oil blend) called QueaseEASE to help with nausea after spinal fusion surgery for idiopathic scoliosis 
• Who is this for? Adolescents and adults from 12 to 21 years old who have idiopathic scoliosis and are undergoing initial posterior spinal fusion 
• Who is the doctor in charge of this study? Lindsey N. Locke, MSN, CPNP-PC  

Status: Active not recruiting

If you are interested in enrolling or would like more information, please contact the study coordinator: Jonathan Rowland, 901.287.6856, Jonathan.Rowland@lebonheur.org.  

Evaluation of Conventional Strap Tension, Constant-Tension Units, and a Modified Brace for Adolescent Idiopathic Scoliosis (AIS) 

• What kind of research is this? A study of current bracing technology to assist in the development of a new treatment called the Constant Tension Unit (CTU) 
• Who is this for? Children and adolescents 5 to 17 years old who have been diagnosed with Idiopathic Scoliosis 
• Who is the doctor in charge of this study? Denis DiAngelo, PhD (no biography webpage) 

Status: We are currently looking for patients for this study 

If you are interested in enrolling or would like more information, please contact the study coordinator: Jonathan Rowland, 901.287.6856, Jonathan.Rowland@lebonheur.org.  

Scoliosis Analog Model for Evaluation of Bracing Technology  

• What kind of research is this? A study to improve current bracing technology for scoliosis and develop a new and better brace 
• Who is this for? Children and adolescents 5 to 17 years old who have been diagnosed with Idiopathic Scoliosis 
• Who is the doctor in charge of this study? Denis DiAngelo, PhD 

Status: We are currently looking for patients for this study 

If you are interested in enrolling or would like more information, please contact the study coordinator: Jonathan Rowland, 901.287.6856, Jonathan.Rowland@lebonheur.org.  

• No current trials available. Please check back later.

• No current trials available. Please check back later.