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	Currently Enrolling	Description	Contact Information
NCT03971071	Ferguson	Yes	(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
NCT03012776	Phan	Yes	(TOPS IDE) A Clinical Study to Assess the Safety and Effectiveness of the Premia Spine TOPS™ System.	Daniell Gallagher
NCT04032093	Keblawi	No	(Matisse) A Phase 2B Placebo-Controlled, Randomized Study of a Respiratory Syncytial Virus (RSV) Vaccine in Pregnant Women	Hillary Salava
NCT03926130	Sundaram	Yes	(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	No	A Retrospective Multicenter Comparison of Laparoscopic and Robotic-Assisted Roux-en-Y Gastric Bypass and Sleeve Gastrectomy (Retro Bariatric)	Daniell Gallagher
NCT04140305	Ferguson	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	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	Yes	[EXPEDITION] An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis	Nicole Finley
NCT03537508	Shields	No	(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
NCT03759288	Sundaram	Yes	(Intrepid) An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Crohn's Disease	Nicole Finley
NCT04396236	Lopez	Yes	(PIONEER-PEDS1) A Study of Lasmiditan (LY573144) Treatment in Children Aged 6 to 17 With Migraine	David Coates
NCT04396574	Lopez	Yes	(PIONEER-PEDS2) A 12-Month Study of Lasmiditan (LY573144) Treatment in Children Aged 6 to 17 With Migraine	David Coates
NCT04506190	Nease	Yes	(ISI-dVBAR-002) A Prospective Multicenter Study to Evaluate the Perioperative Outcomes of Laparoscopic and Robotic-assisted Revisional Bariatric Surgery	Daniell Gallagher
Protocol I5Q-MC-B004	Ferguson	Yes	(TRIUMPH) Preventive Treatment of migraine: Outcomes for Patients in real-world Healthcare systems	Daniell Gallagher
TP-201920	Gentile	Yes	(Trauma Screw) An Observational Study to Gather Real-World Data on the Tyber Medical Trauma Screw System	Daniell Gallagher
P255-501	Lopez	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	Yes	A Randomized, Double-Blind, Controlled Study to Assess the Efficacy and Safety of Intravenous Phenobarbital in Neonatal Seizures	Gina Finley
N/A	Villa	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	Yes	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
CLP-001	Webb	Yes	(RESET-RA) A Randomized, Sham-Controlled, Double-Blind Study of Vagus Nerve Stimulation for Moderate to Severe Rheumatoid Arthritis	Daniell Gallagher

Updated on February 22, 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	Description	Contact Information
NCT04144738	Sundaram	(BLUE-C) Clinical Validation of an Optimized Multi-Target Stool DNA (mt-sDNA 2.0) Test, for Colorectal Cancer Screening	Nicole Finley
NCT03887715	Holroyd	(RECOVER) A Prospective Multi-Center, Randomized Controlled Blinded Trial Demonstrating the Effectiveness of VNS Therapy® System as Adjunctive Therapy Versus a No-Stimulation Control in Subjects with Treatment-Resistant Depression	Hillary Salava
NCT03290560	Nolte	(REMEDY II) Phase 2/3 Adaptive Design, Randomized Double-Blond Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of DM199 for the Treatment of Acute Ischemic Stroke	Hillary Salava
NCT05164172	Lopez	(Lundbeck) Long-term Open Label (Dose-Blinded), Extension Study of Eptinezumab in Children and Adolescents with Chronic or Episodic Migraine	TBD

Updated on February 22, 2021.

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.
1632953	Sundaram, Uma	Activated Charcoal COVID-19

Updated on April 20, 2021.