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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 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