ICoN-1: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Efficacy and Safety of Treatment With MNKD-101 (Clofazimine Inhalation Suspension) When Added to Guideline-Based Therapy in Participants with Pulmonary Nontuberculous Mycobacterial Infection (Part A) Followed by an Open-Label Extension (Part B)

Date Added
February 7th, 2025
PRO Number
Pro00136819
Researcher
Patrick Flume

List of Studies


Keywords
Nontuberculous mycobacteria (NTM)
Summary

Part A of this study will compare the effects of Clofazimine Inhalation Suspension to placebo. The purpose of this study is to find out if Clofazimine Inhalation Suspension can treat NTM lung disease by getting rid of the bacteria from the lungs and to make sure that Clofazimine Inhalation Suspension is safe for use. The participant will continue with current treatment for NTM lung disease in this study. To test if the bacteria are gone from the lungs, sputum will be tested on a regular basis (every month) to see if the culture changes from positive to negative. Participants will be randomly assigned by chance (like drawing numbers from a hat) to either Clofazimine Inhalation Suspension or placebo.

After the participant completes the study treatment in Part A, they will be eligible to receive Clofazimine Inhalation Suspension in Part B.

Approximately 234 participants will take part in the study at approximately 120 sites globally.

Institution
MUSC
Recruitment Contact
Isabella Brookshire
8437920965
recruitment@musc.edu

StrokeNet Thrombectomy Endovascular Platform

Date Added
February 6th, 2025
PRO Number
Pro00140267
Researcher
Christine Holmstedt

List of Studies


Keywords
Stroke
Summary

STEP is a Randomized, Multifactorial, Adaptive Platform trial that seeks to optimize the care of patients with acute ischemic stroke (AIS) due to large or medium vessel occlusions (LVOs and MVOs).STEP is a registry-based trial; it uses data from existing registries to record information for a subset of the trial Case Report Form (CRF). Additional registry data from non-randomized STEP patients may be used for trial screening, planning, and generalizability assessment purposes.

Institution
MUSC
Recruitment Contact
Caitlan LeMatty
843-792-8606
lemattyc@Musc.edu

A Randomized, Double-blind, Multicenter, Parallel-group, Phase IIIb 52 Week Study Evaluating the Efficacy and Safety of PT027 Compared with PT007 Administered As Needed in Participants 12 to < 18 Years of Age with Asthma (ACADIA)

Date Added
February 6th, 2025
PRO Number
Pro00140063
Researcher
Kelli Williams

List of Studies


Keywords
Allergy, Asthma, Pediatrics
Summary

This is a randomized, double-blind, multicenter, parallel-group Phase IIIb study with a fixed treatment period of 52 weeks. The purpose of this study is to compare BDA MDI with AS MDI on severe asthma exacerbations in adolescent participants aged 12 to < 18 years with a documented clinical diagnosis of asthma and at least one severe exacerbation in the prior year. Participants will administer randomized IMP as needed as they normally would with their own prescribed rescue inhaler.

Institution
MUSC
Recruitment Contact
Sydnee Pearson
8437926690
pearsosy@musc.edu

BradycArdia paCemaKer with AV interval modulation for Blood prEssure treAtmenT (BACKBEAT Trial)

Date Added
January 28th, 2025
PRO Number
Pro00141987
Researcher
Sergio Pinski

List of Studies

Keywords
Heart, Hypertension/ High Blood Pressure
Summary

This study is enrolling subjects with high blood pressure who just received a pacemaker (an implantable device placed in the upper chest that monitors the heart rate and can send an electrical signal if needed to pace the heart to maintain a normal heart rate) or are about to undergo a pacemaker implant. This is a randomized study meaning subjects will be assigned by chance to have a new program downloaded to the pacemaker to help control blood pressure or to not receive the program. Subjects will have a 50:50 chance to receive the program. The new program is called AVIM therapy and it is investigational meaning it has not been approved by the US Food and Drug Administration. (FDA) Participation in this study will last about 36 months and include about 10 visits. Study related procedures include blood pressure monitoring including wearing a 24 hour blood pressure monitor, blood work, questionnaires, echocardiogram - an ultrasound test of the heart, pacemaker interrogation (meaning your pacemaker is checked to obtain the information stored on it) and randomization. Study related risks include risks related to the software download such as the risk that the software will not help control blood pressure, risks related to study related procedures and the risk of the loss of confidentiality.

Institution
MUSC
Recruitment Contact
Krista Szymanski
843-876-5783
szymankr@musc.edu

A Phase 3, Open-Label, Multicenter Study of I-124 evuzamitide as an Imaging Agent for the Diagnosis of Cardiac Amyloidosis using Positron Emission Tomography Computed Tomography (PET/CT)

Date Added
January 28th, 2025
PRO Number
Pro00141834
Researcher
Jan Griffin

List of Studies

Keywords
Drug Studies, Heart
Summary

This study is testing a new radiotracer dye called I-124 evuzamitide in patients with suspected cardiac amyloidosis. Cardiac amyloidosis occurs when proteins misfold and deposit as amyloid fibrils in the heart. The build up of these fibrils (proteins) cause the heart to enlarge due to wall thickening so the heart has to work harder. Over time, this can lead to heart failure. I-124 evuzamitide is given during a Positron Emissions Tomography/ Computed Tomography (PET/CT) scan to help diagnose cardiac amyloidosis. It is not a treatment for amyloidosis. I-124 evuzamitide is considered investigational meaning it is not approved for commercial use by the Food and Drug Administration. (FDA). It will be given one time through an intravenous line, meaning in the vein before the PET/CT scan.

This study will last about 60 days and include 4 visits. The final study visit will take place at day 30 but medical records will be reviewed up to day 60. In addition to receiving I-124 evuzamitide, participants will also receive potassium iodide, an approved medication, by mouth to take for 3 days to protect the thyroid gland from the radiotracer I-124 evuzamitide, electrocardiogram (ECG), bloodwork and questionnaires.

Institution
MUSC
Recruitment Contact
Ellie Cutright
843-876-5011
cutrighe@musc.edu

A randomized, double-blind, placebo-controlled, parallelgroup, Proof-of-Concept (PoC) study to assess the efficacy, safety and tolerability of itepekimab, in participants with non-cystic fibrosis bronchiectasis

Date Added
January 24th, 2025
PRO Number
Pro00142015
Researcher
Patrick Flume

List of Studies


Keywords
Bronchiectasis
Summary

This study is to evaluate an investigational study drug, itepekimab, for the treatment of bronchiectasis. The main purpose for this study is to assess the safety, efficacy, and tolerability of itepekimab in bronchiectasis in addition to the current background treatment you are receiving which may include bronchodilators, inhaled corticosteroids, mucolytics, and/or maintenance antibiotics. You will receive either the study drug or a placebo if you participate in this research. This study will include about 300 participants with bronchiectasis across approximately 20 countries worldwide.

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

A Phase 2, Global, Multicenter, Long-term Safety Study Designed to Assess the Safety and Tolerability of BHV-7000 in Subjects with Refractory Focal Onset Epilepsy

Date Added
January 24th, 2025
PRO Number
Pro00137514
Researcher
Zeke Campbell

List of Studies


Keywords
Epilepsy
Summary

This research study is being done to see the long term effectiveness and safety of a new drug called BHV-7000 as a possible treatment for focal seizures for patients who are taking anti-seizure medications (ASMs) and still experience seizures. You could be eligible to participate in the study if you completed the first double blind study successfully and your study doctor see's that you meet all the criteria for this study.

Institution
MUSC
Recruitment Contact
Robin Bulgarino
18437921115
bulgarino@musc.edu

Preoperative 5-Day Radiotherapy for Soft Tissue Sarcoma: A Single Institution Phase II Trial

Date Added
January 21st, 2025
PRO Number
Pro00141818
Researcher
Jennifer Harper

List of Studies


Keywords
Cancer
Summary

This study is for subjects that have been diagnosed with cancer in their
arm, leg, or trunk (the part of the body that involves the chest, abdomen,
and pelvis). The purpose of this research study is to preserve healthy
tissue around the cancer on the arm(s) and/or leg(s) using
hypofractionated radiotherapy, while treating the cancer and preventing
it from spreading to other areas of the body. This study will look at early side effects and effectiveness of preoperative 5-day hypofractionated radiotherapy. Active participation in the study will take about 12 visits and are completed once the participant has a 6-month post-operation visit.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

Task-based synchronous electroencephalography and functional magnetic resonance imaging (EEG-fMRI) to explore neural representations of memory maintenance in the aging brain.

Date Added
January 21st, 2025
PRO Number
Pro00141769
Researcher
Kirstin-Friederike Heise

List of Studies

Keywords
Aging, Healthy Volunteer Studies
Summary

The purpose of this study is to better understand how practicing a new skill builds a stable memory and how this memory is maintained over time as one gets older. A better understanding how memories are controlled in healthy aging may help to develop better treatments for memory problems.
The study's main question is how the different brain regions communicate with each other when one is retrieving memories of a well-practiced skill. Specifically, when and where the brain waves that are related to skill memory are produced. The brief changes in the brain will be recorded with functional magnetic resonance imaging (fMRI), a medical technology that looks at blood flow in the brain. To assess electrical changes in the brain, the brain waves, electroencephalography (EEG) will be used. Combining EEG and fMRI will allow the precise detection of the exact location where the brain is active at any moment in time.
This study is conducted at the Medical University of South Carolina (MUSC). The study will take about one to two weeks and involves two visits to MUSC including an interview and combined brain recording and brain scan during task practice (EEG-fMRI) and up to 7 days of online skill practice at home. Volunteers in this research study must be free of any brain disease or brain injuries and have to be in good health status. Approximately 40 volunteers will take part in this study.

Institution
MUSC
Recruitment Contact
Kirstin-Friederike Heise
(843)792-3435
heisek@musc.edu

Frontier Study: A Multicentered Retrospective Chart Review of Non-Invasive Prenatal Testing for Inherited Monogenic Disorders, Rh Incompatibility and Common Aneuploidies

Date Added
January 21st, 2025
PRO Number
Pro00140738
Researcher
Eliza McElwee

List of Studies


Keywords
Obstetrics and Gynecology
Summary

This is a retrospective chart review study looking at the assessment of the clinical performance of single gene non-invasive prenatal screening and comparison to standard of care.

Institution
MUSC
Recruitment Contact
Jesslyn Payne
843-792-7525
paynej@,usc.edu



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