Clinical Trials

To promote clinical and translational research in order to provide advance 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 Benefit
      • 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
  • Daniell Gallagher – Clinical Coordinator
  • David Coates – Clinical Coordinator
  • Hillary Salava – Clinical Coordinator
  • Gina Finley – Clinical Coordinator
  • Jessica Merrick – Clinical Coordinator
  • Mary Beth Cordle – Quality Officer
  • Michelle Peters – Administrative Assistant
Active Clinical Trials  
Study ID  PI  Currently Enrolling  Description  Contact Information 
NCT03971071 Ferguson No (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 No (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
NCT04821310 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 Heale David Coates
NCT03887715 Holroyd 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 Salva
964144 Sundaram Yes Jennifer Haynes; Nicole Finley
NCT0564172 Lopez 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 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 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 Ferguson No (TRIUMPH) Preventive Treatment of migraine: Outcomes for Patients in real-world Healthcare systems Daniell Gallagher
N/A Sundaram No Activated Charcoal to Treat COVID-19 Patients to Improve Health Outcomes Nicole Finley
NCT03996369 Sundaram No (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 No (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
NCT03290560 Nolte No (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
NCT03466411 Sundaram No (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
N/A Frandah No (DESTIN) – Randomized Trial Comparing Immediate Endoscopic Necrosectomy vs. Step-up Endoscopic Interventions in Necrotizing Pancreatitis Jessica Merrick
NCT04144738 Sundaram No (BLUE-C) – Clinical Validation of an Optimized Multi-Target Stool DNA (mt-sDNA 2.0) Test, for Colorectal Cancer Screening Nicole Finley