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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  Enrolling  Description  Contact Information 
NCT03971071
Ferguson  Yes A Study to Evaluate the Efficacy and Safety of Erenumab in Adults With Medication Overuse Headache  Scott Wiley 
NCT01809002
Koester  No Comparison of Processed Nerve Allograft and Collagen Nerve Cuffs for Peripheral Nerve Repair (AxoGen AVIVE) Sandra Finley (Ortho)
NCT01442194 Ferguson  No Safety Study in Patients With Multiple Sclerosis Treated Fingolimod or Other Approved Disease-modifying Therapies  (PASSAGE)  Linda Morgan 
NCT03257358 Ferguson  N/a A Study of Immune Phenotype Biomarkers in Patients With Relapsing Multiple Sclerosis (RMS) After Treatment With 0.5mg Fingolimod (FLUENT) - Closed to Enrollment Linda Morgan 
NCT03277313 Shephard No Efficacy, Safety, Tolerability, Immunogenicity and Pharmacokinetic Evaluation of HYQVIA in Pediatric PIDD Subjects   Nicole Finley 
NCT03537508 Shields Yes Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine when Administered Concomitantly with Routine Pediatric Vaccines in Healthy Infants and Toddlers in the US (MET 42 SANOFI)  Robin Ashford, Mallori Scarberry; Sara Runyon 
NCT03012776 Phan  Yes A Pivotal Study of the Premia Spine TOPS System (TOPS IDE) Linda Morgan 
NCT02907177 Ferguson  No Clinical Study to Compare the Efficacy and Safety of Ponesimod to Placebo in Subjects With Active Relapsing Multiple Sclerosis Who Are Treated with Dimethyl Fumarate (Tecfidera)(POINT) - Closed to Enrollment  Linda Morgan 
NCT04032093 Keblawi No A Phase 2B Placebo-Controlled, Randomized Study of a Respiratory Syncytial Virus (RSV) Vaccine in Pregnant Women   Robin Ashford 
NCT01809002 Koester  Yes  Comparison of Processed Nerve Allograft and Collagen Nerve Cuffs for Peripheral Nerve Repair (RECON) Sandra Finley (Ortho)
NCT03028740 Sundaram Yes AURORA: Phase 3 Study for the Efficacy and Safety of CVC for the Treatment of Liver Fibrosis in Adults with NASH Nicole Finely 
NCT03781791 Shivkumar Yes Orally Administered ENT-01 for the Treatment of Parkinson's Disease-Related Constipation (KARMET)
Sara Runyon
NCT03984305 Shivkumar  Yes Utilization of Target Ranges to Treat Patients with Parkinson's Disease by Objective Measurement Using the Personal KinetiGraph (PKG) compared to Standard of Care Assessment (TARGET-PD)- A Randomized Controlled Trial Study 003 Sara Runyon 

Updated on April 3, 2020. 

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 
827507 Egleton, Richard  NAS 
921118 Cyphert, Holly HERD 2020/2021
GRANT  Sundaram, Uma  NIH COBRE
GRANT  Sundaram, Uma NIH Ro1
GRANT  Sundaram,  Uma  Ro1NET
499630 Koester, Alan AVANTA (SRTMMCP)
463451 Koester, Alan AVANTA (SRTMPIP)

Updated on April 3, 2020.  

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 
APD334-202A Sundaram  Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction Therapy in Subjects with Moderately to Severely Active Crohn’s Disease (CULTIVATE) Nicole Finley; Kristina Childers
APD334-202 Sundaram An Open-Label Extension Study of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis (ELEVATE OLE) Nicole Finley; Kristina Childers
APD334-302 Sundaram A Phase 3, Randomized, Double‑Blind, Placebo‑Controlled, 12‑Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis Nicole Finley; Kristina Childers
C3671008 Keblawi A Phase 3, Randomized, Double or Observer-Blinded, Placebo Controlled Trial to Evaluate The Efficacy and Safety of a Respiratory Syncytial Virus (RSV) Prefusion F Subunit Vaccine in Infants Born to Women Vaccinated During Pregnancy.  Mallori Scarberry; Sara Runyon
RPC-1063 Ferguson A Mutlicenter, Longitudinal, Open-Label, Single-Arm Study Describing Cognitive Processing Speed Changes in Relapsing Multiple Sclerosis Subjects Treated with Ozanimod Sara Runyon 
H8H-MC-LAHV  Lopez Pediatric Options for MigraineRelief: A Randomized, Double-Blind, Placebo-Controlled Study of Lasmiditan for Acute Treatment of Migraine Scott Wiley 
CLI-06563AA1-02 Govindaswami A Phase II, multicenter, double blind, double dummy, randomized, 2 arms parallel study to evaluate the efficacy, safety and pharmacokinetics of CHF6563 in babies with Neonatal Opioid Withdrawal Syndrome (NOWSHINE) Mallori Scarberry; Sara Runyon
Protocol I5Q-MC-B004 Ferguson Preventive TReatment of mIgraine: oUtcoMes for Patients in real-world Healthcare systems (TRIUMPH) Scott Wiley
LIN-MD-67 Shields; Villa A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Sequential, Ascending, Multidose Study to Evaluate the Safety and Efficacy of Linaclotide in Pediatric Participants (Age 2 to 5 Years) with Functional Constipation Scott Wiley; Sara Runyon
LIN-MD-64 Shields; Villa A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Sequential, Ascending, Multidose Study to Evaluate the Safety and Efficacy of Linaclotide in Pediatric Participants (Age 6 to 17 Years) with Functional Constipation Scott Wiley; Sara Runyon

Updated on April 3, 2020.