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.