Clinical Trials

To promote clinical and translational research to provide advanced care that is currently unavailable for the residents of our Tristate Metro Community (West Virginia, Southern Ohio, and Eastern Kentucky). Since its creation, the Clinical Research Center has provided development and support to dozens of clinical trials, improving treatment for hundreds of patients.

Guiding Principles

Long Term Engagement

  • Research Investigators are our long-term partners. The MCRC Seeks to build a lasting partnership with all of the researchers at the Joan C. Edwards School of Medicine.

Mutual Benefits

  • The MCRC understands the role and pressures of being a primary investigator.  It is our goal to enhance the environment, research, and reputation of each of our partners.

Professionalism

  • The MCRC staff will work together with humility, candor, and mutual respect for expertise and cultural differences when communicating with researchers and community members.

Shared Responsibility

  • All Partners have obligations towards the patients, the project, the community, and each other.

Integrity

  • All decisions and actions will be based on optimizing best practices, maintaining data integrity, assuring safety, and upholding the highest standards of medical ethics and scientific quality.

Vision: We will be a world leader in community-academic clinical research supporting medical innovation and care in Appalachia. To realize this vision, we strive to:

  • Develop a new standard for scholarship in clinical research.
  • Nurture an environment of collaboration, creativity, and professional development throughout the Marshall research community.
  • Foster a goal-oriented and balanced approach to research.
  • Advance effective strategic alliances.
  • Provide access to cutting-edge healthcare opportunities to the underserved community.

Clinical Trials Staff

  • Usha Murughiyan (Assistant Dean for Clinical Trials)
  • Nicole Finley – Lead Clinical Coordinator
  • Amber Vickers – Clinical Coordinator
  • David Coates – Clinical Coordinator
  • Hillary Salava – Clinical Coordinator
  • Gina Finley – Clinical Coordinator
  • Jessica Merrick – Clinical Coordinator
  • Mary Beth Cordle – Quality Officer
  • Carlie Harrah – Executive Administrative Assistant

For more information regarding clinical trials, please contact Usha Murughiyan,  (304)-691-1836,  murughiyan@marshall.edu.

Active Clinical Trials

Study ID PI Specialty Disease Process Enrollment Status Description Contact Information
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 
NCT05686070 Lopez Neurology Acute Stroke Yes OCEANIC Stroke: A multicenter, international, randomized, placebo controlled, double-blind, parallel group and event driven Phase 3 study of the oral FXIa inhibitor asundexian (BAY 2433334) for the prevention of ischemic stroke in male and female participants aged 18 years and older after an acute non-cardioembolic ischemic stroke or high-risk TIA Gina Finley
Sherif Gastrointestinal Cirrhosis Not yet RED-C: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of Rifaximin Soluble Solid Dispersion (SSD) Tablets for the Delay of Encephalopathy Decompensation in Cirrhosis Nicole Finley 
NCT06063967 Sundaram Gastrointestinal Crohn’s Disease Not yet AFFIRM: A Phase 3, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Efficacy and Safety of Risankizumab Subcutaneous Induction Treatment in Subjects with Moderately to Severely Active Crohn’s Disease Nicole Finley 
Sundaram Gastrointestinal Ulcerative Colitis Not yet LUTI: A Multicenter, Randomized Study to Evaluate the Safety and Efficacy of Lutikizumab for
Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis
Nicole Finley 
NCT05776225 Al-Astal Pulmonology Pulmonary Hypertension Not yet PHINDER: Pulmonary Hypertension Screening in Patients with Interstitial
Lung Disease for Earlier Detection
Amber Diehl
NCT05970263 Khawaja Pulmonology

COPD

Not yet IKANOS: A Prospective, Open-Label, Minimally Interventional
Hybrid Study in the US Comparing Initiation of Breztri
Maintenance versus Any Non-Triple Inhaled Therapy at
Discharge after a Hospitalization for a COPD Exacerbation
Gina Finley
Khawaja Pulmonology

Post-Acute Sequelae of SARS-CoV-2 Infection (PASC

Not yet Junonia: Postpartum Depression Longitudinal Study: A Care Coordination Intervention Hillary Salava
NCT05905926 Villa Pediatric Gastrointestinal

IBS-Constipation

Not yet RALLY: A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Assess the Safety and Efficacy of Tenapanor for the Treatment of Irritable Bowel Syndrome with Constipation (IBS-C) in Pediatric Patients 12 to Less than 18 Years Old Jessica Merrick
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
NCT04821310 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
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
NCT0564172 Lopez Neurology Pediatric Migraine Yes (REJOIN) Long-term Open Label (Dose-Blinded), Extension Study of Eptinezumab in Children and Adolescents with Chronic or Episodic Migraine  Jessica Merrick
NCT05242471 Sundaram Gastrointestinal Chron’s Disease Yes (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
NCT04965675 Lopez Neurology Pediatric Migraine Yes Interventional, randomized, double-blind, parallel group, placebo-controlled study to evaluate the efficacy and safety of IV eptinezumab in adolescents (12-17 years) for the preventative treatment of chronic migraine. Jessica Merrick
N/A Sundaram/Haynes COBRE Development of Organoids Yes Regulation of Intestinal Nutrient and Electrolyte Transport in chronic Disease Jennifer Haynes
N/A Sundaram/Singh COBRE Adipose Derived Secretome/Absorption Yes Adipose derived secretome (ADS) uniquely regulates intestinal epithelial cell nutrient absorption during obesity. Soudamani Singh
N/A Sundaram / Palaniappan COBRE Adenoma / Colorectal Cancer Yes Mechanism of regulation of Down regulated Adenoma (DRA) transporter in obesity associated colitis. Bala Palaniappan
499630 Koester Orthopedic Surgery Metacarpal Tendon Repair Yes Humanitarian Use Device (HUD) for surgical repair of metacarpal tendon. Dr. Koester/ Mary Beth Cordle
463451 Koester Orthopedic Surgery Metacarpal Tendon Repair Yes Humanitarian Use Device (HUD) for surgical repair of metacarpal tendon. Dr. Koester/ Mary Beth Cordle
964144 Sundaram / Arthur RO1 / COBRE Nutrient and Electrolyte Transport Yes Regulation of Intestinal Nutrient and Electrolyte Transport in Chronic Disease Subha Arthur
N/A Sundaram / Cecchetti DCTS / COBRE Integrating Biology Yes Marshall University School of Medicine Informatics for Integrating to the Biology to the Bedside (I2B2) Alfred Cecchetti
N/A Sundaram / Cecchetti DCTS / COBRE Helicobacter Pylori Yes Helicobacter Pylori ( H. Pylori) in Apppalachia Jacqueline Cavendish
N/A Sundaram / Cecchetti DCTS / COBRE Metabolic Syndrome Classification Yes Classification of Metabolic Syntrome Patients Using a Data Warehouse Developed Algorithm Alfred Cecchetti

Updated on January 22, 2024