Clinical Trials Overview

Below is a list of currently enrolling Clinical Trials at the Appalachian Clinical and Translational Science Institute (ACTSI). If you would like additional information about a specific trial, you can call the contact number provided and speak with a study coordinator.

Additional information about each trial can be obtained at ClinicalTrials.gov by clicking on the descriptions below

For more information regarding Active Clinical Trials, contact our Medical Director of Clinical Trials - Usha Murughiyan (304) 691-1836.

Active Clinical Trials
Study ID	PI	Specialty	Disease Process	Currently Enrolling	Description	Contact Information
NCT04140305	Ferguson	Neurology	Multiple Sclerosis	Yes	(ENLIGHTEN) A Multicenter, Longitudinal, Open-Label, Single-Arm Study Describing Cognitive Processing Speed Changes in Relapsing Multiple Sclerosis Subjects Treated with Ozanimod	David Coates
NCT04173273	Sundaram	Gastrointestinal	Crohn's Disease	Yes	(CULTIVATE) Study Evaluating the Efficacy and Safety of Oral Etrasimod in the Treatment of Adult Participants With Moderately to Severely Active Crohn's Disease	Nicole Finley
NCT03616821	Sundaram	Gastrointestinal	Ulcerative Colitis	Yes	[D5271C0001 - EXPEDITION] An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis	Nicole Finley
NCT03759288	Sundaram	Gastrointestinal	Crohn's Disease	Yes	(D5271C0001 - Intrepid) An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Crohn's Disease	Nicole Finley
NCT04396236	Lopez	Neurology	Pediatric Migraine	Yes	(PIONEER-PEDS1) A Study of Lasmiditan (LY573144) Treatment in Children Aged 6 to 17 With Migraine	David Coates
NCT04396574	Lopez	Neurology	Pediatric Migraine	Yes	(PIONEER-PEDS2) A 12-Month Study of Lasmiditan (LY573144) Treatment in Children Aged 6 to 17 With Migraine	David Coates
TP-201920	Gentile	Orthopedic Surgery	Podiatric Screw Placement	Yes	(Trauma Screw) An Observational Study to Gather Real-World Data on the Tyber Medical Trauma Screw System	Daniell Gallagher
P255-501	Lopez	Neurology	Pediatric Migraine	Yes	(ROAR) A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 4 Study to Evaluate the Efficacy and Safety of Qudexy® XR in the Prevention of Migraine in Children 6 to 11 Years of Age	David Coates
NCT04320940	Massey	NICU	Neonatal Seizures	Yes	A Randomized, Double-Blind, Controlled Study to Assess the Efficacy and Safety of Intravenous Phenobarbital in Neonatal Seizures	Gina Finley
N/A	Villa	Gastrointestinal	Erosive Esophagitis	Yes	(KEEP)An Exploratory, Multicenter, Randomized, Double-Blind Study of Clinical Outcomes, Tolerability, and Safety of 2 Doses of Oral Pantoprazole in Pediatric Participants, Aged 1 to 11 Years and 12 to 17 Years Who Require Maintenance Therapy for Healed Erosive Esophagitis	David Coates
NTC04938830	Shields	Pediatrics	RSV	Yes	(Asservo) - A Phase 3, Multicenter, Randomized, Partially Blinded, Palivizumab- Controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of MK-1654 in Infants and Children at Increased Risk for Severe RSV Disease	Gina Finley
NCT04144738	Sundaram	Gastrointestinal	Colon Cancer Screening	Yes	(BLUE-C) - Clinical Validation of an Optimized Multi-Target Stool DNA (mt-sDNA 2.0) Test, for Colorectal Cancer Screening	Nicole Finley
NCT03887715	Holroyd	Mental Health	Treatment-Resistant Depression	Yes	(RECOVER) - A PRospective, Multi-cEnter, Randomized Controlled Blinded Trial DemOnstrating the Safety and Effectiveness of VNS Therapy® System as AdjunctivE Therapy Versus a No Stimulation Control in Subjects With Treatment-Resistant Depression	Hillary Salava
964144	Sundaram	Gastrointestinal	NIH/RO1 Grant	Yes	Regulation of Intestinal Nutrient and Electrolyte Transport in Chronic Disease	Jennifer Haynes; Nicole Finley

Updated on September 30, 2022.

For more information regarding Upcoming Clinical Trials, contact our Medical Director of Clinical Trials - Usha Murughiyan (304) 691-1836.

Active Clinical Trials
Study ID	PI	Specialty	Disease Process	Currently Enrolling	Description	Contact Information
NCT05164172	Lopez	Neurology	Pediatric Migraine	Pending Activation	(Lundbeck) Long-term Open Label (Dose-Blinded), Extension Study of Eptinezumab in Children and Adolescents with Chronic or Episodic Migraine	Jessica Merrick
N/A	Sundaram	Gastrointestinal	Peripheral Artery Disease	Pending Activation	ICE-PAD: Improving Care via the HER in PAD	Informatics Technology
N/A	Sundaram	Gastrointestinal	Hepatitis	Pending Activation	HCV Patient Identification Algorithm	Informatics Technology
NCT03466411	Sundaram	Gastrointestinal	Ulcerative Colitis	Pending Activation	(GALAXI) - A Phase 2/3, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease	Nicole Finley
NCT05242471	Sundaram	Gastrointestinal	Crohn's Disease	Pending Activation	(DUET-CD) - A Phase 2b Randomized, Double-blind, Active- and Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Induction and Maintenance Combination Therapy with Guselkumab and Golimumab in Participants with Moderately to Severely Active Crohn’s Disease	Nicole Finley
N/A	Frandah	Gastrointestinal	Pancreatitis	Pending Activation	(DESTIN) - Randomized Trial Comparing Immediate Endoscopic Necrosectomy vs. Step-up Endoscopic Interventions in Necrotizing Pancreatitis	Jessica Merrick
	Lopez	Neurology	Pediatric Migraine	Pending Activation	PCORI Grant with Cincinnati Children's Hospital - CBT via Telehealth + Amitriptyline Compared to CBT via Telehealth: Pediatric Migraine Prevention

Updated on September 30, 2022.

For more information on PI Initiated Clinical Trials, contact our Medical Director of Clinical Trials - Usha Murughiyan (304) 691-1836.

PI Initiated Clinical Trials
IRB Number	PI	Description
GRANT	Sundaram, Uma	NIH COBRE
GRANT	Sundaram, Uma	NIH Ro1
GRANT	Sundaram, Uma	Ro1NET
499630	Koester, Alan	AVANTA (SRTMMCP)
463451	Koester, Alan	AVANTA (SRTMPIP)
964144	Sundaram, Uma	Regulation of intestinal nutrient and electrolyte transport in chronic diseases.

Updated on September 30, 2022.

Completed Trials

Study ID	PI	Specialty	Disease Process	Comments	Description	Contact
NCT03971071	Ferguson	Neurology	Multiple Sclerosis	Closed - Moved to Historical Lab	(AMGEN) A Phase 4, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Erenumab in Adults With Chronic Migraine and Medication Overuse Headache	Daniell Gallagher
NCT03926130	Sundaram	Gastrointestinal	Chrohn's Disease	Closed - Moved to Historical Lab	(VIVID-1 AMAM) A Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Treat-Through Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Moderately to Severely Active Crohn's Disease	Nicole Finley
NCT04329780	Nease	Bariatrics	Multicenter Study to Evaluateosos	Closed - Moved to Historical Lab	(ISI-dVBAR-002) A Prospective Multicenter Study to Evaluate the Perioperative Outcomes of Laparoscopic and Robotic-assisted Revisional Bariatric Surgery	Daniell Gallagher
N/A	Ferguson	Neurology	Chronic Migraine	Closed - Moved to Historical Lab	(TRIUMPH) Preventive Treatment of migraine: Outcomes for Patients in real-world Healthcare systems	Daniell Gallagher
N/A	Sundaram	Gastrointestinal	COVID	Closed - Moved to Historical Lab	Activated Charcoal to Treat COVID-19 Patients to Improve Health Outcomes	Nicole Finley
NCT03996369	Sundaram	Gastrointestinal	Ulcerative Colitis	Closed - Moved to Historical Lab	(ELEVATE) - A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis	Nicole Finley
NCT03028740	Sundaram	Gastrointestinal	NASH	Closed - Moved to Historical Lab	(AURORA) - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Cenicriviroc for the Treatment of Liver Fibrosis in Adult Subjects with Nonalcoholic Steatohepatitis	Nicole Finley
CLP-001	Webb	Rheumatology	Rheumatoid Arthritis	Closed - Moved to Historical Lab	(RESET-RA) A Randomized, Sham-Controlled, Double-Bline Study of Vagus Nerve Stimulation for Moderate-to-Severe Rheumatoid Arthritis	Daniell Gallagher
NCT03290560	Nolte	Neurology	Acute Ischemic Stroke	Closed - Moved to Historical Lab	(ReMedy II) Phase 2/3 Adaptive Design, Randomized Double-blind Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of DM199 for the Treatment of Acute Ischemic Stroke	Hillary Salava
NCT03012776	Phan	Neurosurgery	Spondylolisthesis	Long Term Follow-Up	(TOPS IDE) A Clinical Study to Assess the Safety and Effectiveness of the Premia Spine TOPS™ System.	Daniell Gallagher
NCT04032093	Keblawi	OB/GYN	RSV	Long Term Follow-Up	(Matisse) A Phase 2B Placebo-Controlled, Randomized Study of a Respiratory Syncytial Virus (RSV) Vaccine in Pregnant Women	Hillary Salava
NCT03537508	Shields	Pediatrics	Meningitis	Long Term Follow - Up	(MET 42) Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers in the US	Gina Finley