Clinical Trials

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 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

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 

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

 NCT05164172/ (PCORI)

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

Jessica Merrick

Updated on January 22, 2024.

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

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

NCT03616821

Sundaram

Gastrointestinal

Ulcerative Colitis

Closed-Moved to Historical Lab

[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

Closed-Moved to Historical Lab

(D5271C0001 - Intrepid) An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Crohn's Disease 

Nicole Finley

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

NCT03466411

Sundaram

Gastrointestinal

Ulcerative Colitis

Closed- Moved to Historical Lab

(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

Gastrointestinal

Pancreatitis

Closed- Moved to Historical Lab

(DESTIN) - Randomized Trial Comparing Immediate Endoscopic Necrosectomy vs. Step-up Endoscopic Interventions in Necrotizing Pancreatitis

Jessica Merrick

NCT04140305

Ferguson

Neurology

Multiple Sclerosis

Closed-Moved to Historical Lab

(ENLIGHTEN) A Multicenter, Longitudinal, Open-Label, Single-Arm Study Describing Cognitive Processing Speed Changes in Relapsing Multiple Sclerosis Subjects Treated with Ozanimod

David Coates

NCT04320940 

Massey

NICU

Neonatal Seizures

Closed-Moved to Historical Lab

A Randomized, Double-Blind, Controlled Study to Assess the Efficacy and Safety of Intravenous Phenobarbital in Neonatal Seizures

 

Gina Finley

NCT04144738 

Sundaram

Gastrointestinal

Colon Cancer Screening

Closed-Moved to Historical Lab

(BLUE-C) - Clinical Validation of an Optimized Multi-Target Stool DNA (mt-sDNA 2.0) Test, for Colorectal Cancer Screening

 

Nicole Finley

TP-201920

 

Gentile 

Orthopedic Surgery

Podiatric Screw Placement

Closed-Moved to Historical Lab

(Trauma Screw) An Observational Study to Gather Real-World Data on the Tyber Medical Trauma Screw System

Daniell Gallagher

NCT03616821

Sundaram 

Gastrointestinal

Ulcerative Colitis

Closed-Moved to Historical Lab

[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

Closed-Moved to Historical Lab

(D5271C0001 - Intrepid) An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Crohn's Disease 

Nicole Finley

Updated on January 22, 2024