A Randomized, Double-Blind, Placebo-Controlled, Single Dose Study to Assess the Safety and Efficacy of SL1002 Injectable for the Treatment of Knee Pain in Patients with Osteoarthritis of the Knee

Date Added
November 12th, 2025
PRO Number
Pro00147576
Researcher
Ameet Nagpal

List of Studies

Keywords
Arthritis, Pain
Summary

The purpose of this phase III study is to assess the safety and efficacy of the SL-1002 injectable formulation, compared to placebo, for the treatment of knee pain associated with osteoarthritis, which is not currently approved by the FDA. This study will last approximately 26 weeks, which includes a screening period that includes 1 or 2 visits. Eligible subjects will undergo a 1:1 randomization with the SL 1002 formula or normal saline used as a placebo. After the screening visits and the study drug treatment visit (Day 1), the subject will be required to return to the study site for 5 additional study visits at approximately 1,2,3,4, and 6 months after the study drug treatment (Day 1). These visits will include physical examinations, knee assessments, patient questionnaires, and the collection of vital signs, and blood and urine samples. This study also requires daily electronic data entries from Day 1 to the end of the study.

Institution
MUSC
Recruitment Contact
Lisa Mock
843-876-2211
mockl@musc.edu

Prospective, non-randomized staged pivotal clinical study to assess the safety and performance of the Xeltis Hemodialysis Access graft: Xeltis aXess US Pivotal

Date Added
November 12th, 2025
PRO Number
Pro00145869
Researcher
MARK LONDON

List of Studies

Keywords
Kidney
Summary

This is a multi-center, prospective, single-arm, non-randomized, staged, pivotal clinical study to evaluate the safety and performance of the aXess graft in subjects aged 18 and above, diagnosed with end-stage kidney disease, and possessing an estimated glomerular filtration rate (eGFR) less than 20 ml/min, who intend to undergo hemodialysis but are considered unsuitable candidates for fistula creation by the investigating surgeon. The alternative option is called an arterio-venous graft (AVG), where the doctor implants a synthetic/artificial tube under the patient's skin, where one end of the tube connects to a vein and the other to an artery. This tube is then used as the ‘access site' during hemodialysis. Participants with ESRD in need of vascular access, and who agree to be in this study, and also meet all the eligibility criteria for participation, will receive the Xeltis aXess graft, a type of AVG as previously described.

Institution
MUSC Health Orangeburg
Recruitment Contact
virginia anderson
803-395-3878
andersvi@musc.edu

A Multi-Center Study Assessing the Safety and Efficacy of the LEGION Medial Stabilized (MS) Insert in Patients Undergoing a Total Knee Arthroplasty (TKA)

Date Added
November 12th, 2025
PRO Number
Pro00145701
Researcher
Erik Hansen

List of Studies

Keywords
Arthritis, Bone, Surgery
Summary

This study is designed to assess the 10-year post-surgery implant survivorship of Total Knee Arthroplasty (TKA) procedures performed using the LEGION Medial stabilized insert, which is FDA approved. Implant survivorship is defined as all of the knee-implanted components without a need for a revision. Questionnaires will be used up to 10 years after surgery to find more about the safety and performance of the device.

Institution
MUSC
Recruitment Contact
Lisa Mock
843-876-0111
mockl@musc.edu

A 16-WEEK, MULTICENTER, INTERVENTIONAL, PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TO INVESTIGATE EFFICACY AND SAFETY OF ABROCITINIB IN CHILDREN 6 TO LESS THAN 12 YEARS OF AGE WITH MODERATE-TO-SEVERE ATOPIC DERMATITIS

Date Added
November 12th, 2025
PRO Number
Pro00144604
Researcher
Lara Wine Lee

List of Studies


Keywords
Skin
Summary

This is a randomized, double-blind, placebo-controlled study to assess the efficacy and safety of abrocitinib compared to a placebo in participants aged 6 to under 12 years with moderate-to-severe AD. Participants will be screened within 28 days before the first dose to confirm eligibility. Those who meet the criteria at baseline will be randomized 2:1 to receive either abrocitinib oral suspension (at a 100 mg adult equivalent dose once daily) or a matching placebo. Participants will be stratified by their baseline vIGA score (3 or 4). They will receive either abrocitinib or a matching placebo for 16 weeks. Additionally, participants must use emollients daily and follow standardized background medicated topical therapy (e.g., low to medium potency corticosteroids) according to protocol guidelines throughout the study's treatment period.

Institution
MUSC
Recruitment Contact
Andie Hoskins
843-792-6882
hoskinsa@musc.edu

Functional Outcomes of a Pickleball Community-Based Exercise Program for Individuals with Parkinson's Disease

Date Added
November 10th, 2025
PRO Number
Pro00148039
Researcher
Vanessa Hinson

List of Studies


Keywords
Exercise, Parkinsons
Summary

The purpose of this research is to explore the effects of participation in a pickleball community-based exercise program on function in people with Parkinson's disease (PwPD). Individuals will engage in an 8-week instructional pickleball exercise program designed specifically by Movement Disorder Specialists at the Medical University of South Carolina for PwPD. The pickleball training program involves warm-up exercises, stroke mechanics, fall safety and recovery technique training, effective movement pattern drills, game play strategies, and match play. We aim to quantify the motor function, balance, mobility, and quality of life outcomes through clinical assessments and questionnaires before and after participation in the Pick it Up Pickleball training program. This research will establish an evidence base for pickleball as a therapeutic intervention, opening the door for additional accessible and engaging exercise options for the PD community.

Institution
MUSC
Recruitment Contact
Isabelle Museck
317-478-7198
museck@musc.edu

Superiority Trial of Aphasia-focused Rehabilitation with tDCS Stimulation

Date Added
November 6th, 2025
PRO Number
Pro00147406
Researcher
Janina Wilmskoetter

List of Studies


Keywords
Language, Stroke Recovery
Summary

The purpose of this study to help us understand if adding transcranial Direct Current
Stimulation (tDCS), a non-invasive brain stimulation technique, to Speech Therapy
improves language recovery in people with Broca's aphasia and is more effective than Speech Therapy alone.

Institution
MUSC
Recruitment Contact
Stephanie Cute
843-792-7049
cute@musc.edu

A Multinational, Long-Term, Open-Label Extension Study of Subjects Who Have Participated in Avalyn Pharma Studies of Inhaled Antifibrotic Agents (AP-LTE-008 SAIL)

Date Added
November 5th, 2025
PRO Number
Pro00146978
Researcher
Timothy Whelan

List of Studies


Keywords
Lung
Summary

This study gives people who were part of an earlier Avalyn research protocol with inhaled pirfenidone versus placebo an opportunity to convert to open label or active investigational drug treatment. The goal is to continue learning additional safety and efficacy information in patients over a longer period of treatment time. Pulmonary fibrosis is a disorder with a poor prognosis that is often far worse than many cancers with limited treatment options. While this medication has yet to be proven effective, the safety profile currently is acceptable and the risks versus benefits favor offering this opportunity to patients with informed consent.

Institution
MUSC
Recruitment Contact
Zerlinna Teague
8437920965
recruitment@musc.edu

Pilot Trial of Written Exposure Therapy Delivered via Telehealth to Adolescents with Posttraumatic Stress Disorder

Date Added
November 4th, 2025
PRO Number
Pro00147573
Researcher
Emily Tilstra-Ferrell

List of Studies

Keywords
Adolescents, Mental Health
Summary

Written Exposure Therapy (WET) is a five-session mental health therapy for post-traumatic stress disorder (PTSD). Research shows that it works as well as longer treatments for PTSD among people over 18, even though it requires fewer sessions than other PTSD therapies. However, WET has not been adapted and tested via telehealth with people aged 12 to 18. Our study aims to see how WET can be adapted to meet the needs of people aged 12 to 18 who have experienced trauma and currently have PTSD symptoms. To adapt WET for this age group, first we will talk with PTSD experts and people aged 12 to 18 to learn what changes might make WET more suitable for young people. We'll also deliver WET via telehealth to five people aged 12 to 18 following the manual as it is written for people over age 18 to see what needs adjusting. In the next part of the study, we will offer the adapted version of WET via telehealth to 20 people aged 12 to 18 in our MUSC integrated pediatric primary care clinic. People aged 12 to 18 will take part in five to seven weekly online therapy sessions and three virtual study visits (before therapy, after therapy, and one month later) to better understand who they are as a person and their current mental health symptoms and diagnoses. Individuals who are 18 can participate without caregiver permission; individuals aged 12 to 17 can only participate with caregiver permission. Our goal is to find the best way to provide effective PTSD treatment for young people that can be delivered in real-world pediatric primary care settings, so that ultimately more people can get the help they need after traumatic experiences.

Institution
MUSC
Recruitment Contact
Owen Winters
843-792-2615
winterso@musc.edu

A pragmatic remote approach to improve transitions of care and retention in opioid use disorder treatment.

Date Added
November 4th, 2025
PRO Number
Pro00146867
Researcher
Allison Smith

List of Studies


Keywords
Psychiatry, Substance Use
Summary

This is a small, test study to see if mailing buprenorphine works for patients with opioid use disorder and a recent medical hospitalization. It tries to remove some of the existing barriers to make it easier to stay in treatment and make it easier for individuals to keep taking their medicine after discharge. The purpose of this research study is to determine if mailing buprenorphine is possible, acceptable, and look at the early results of how well it works.

Institution
MUSC
Recruitment Contact
Hannah Schneider
843-580-8243
schneidh@musc.edu

Autism & Self-regulation: Tele-Assessment of Autonomic Psychophysiological correlates (ASAP)

Date Added
November 4th, 2025
PRO Number
Pro00146541
Researcher
Rosmary Ros-Demarize

List of Studies


Keywords
Autism, Children's Health
Summary

This study aims to evaluate the remote delivery of self-regulation assessments in young children with autism and their parents. Parents will complete online surveys. Parents and children will complete two virtual visits. At the second visit, participants will wear a heart rate monitor while completing study tasks. This study will inform research on behavioral therapies for children with autism.

Institution
MUSC
Recruitment Contact
Alexandra Marsden
843-714-1352
autismresearch@musc.edu



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