A PHASE 3, MULTICENTER, OPEN-LABEL SAFETY STUDY TO EVALUATE THE LONG-TERM SAFETY AND TOLERABILITY OF SAGE-718 IN PARTICIPANTS WITH HUNTINGTON'S DISEASE

Date Added
May 4th, 2023
PRO Number
Pro00125656
Researcher
Federico Rodriguez-Porcel

List of Studies


Keywords
Movement Disorders
Summary

This study is an open-label study that will evaluate SAGE-718 on the cognitive effects in subject with early manifest Huntington's Disease (HD). The subject will be on study drug for a year. At clinic visits, participants will take the IP under staff supervision, followed by assessments of cognitive function, health-related function and quality of life, and neuropsychiatric symptoms.

Institution
MUSC
Recruitment Contact
Sandra Wilson
843-792-4616
wilsosan@musc.edu

UF-HN-004 Risk Adapted De-Intensification of Radio-Chemotherapy for Favorable Prognosis Oropharyngeal Squamous Cell Carcinoma based on HPV subtype and plasma circulating free HPV DNA Level and Clearance Rate.

Date Added
May 16th, 2023
PRO Number
Pro00124145
Researcher
Bhishamjit Chera

List of Studies

Keywords
Cancer, Cancer/Head & Neck, Men's Health, Women's Health
Summary

This study is for patients that have been diagnosed with Oropharyngeal Squamous Cell Carcinoma. The purpose of this research study is to determine if lower doses of radiation therapy are as effective as the standard higher doses. Participants will have tests and procedures that would be performed as part of regular care. Participants will be assigned to one of three study groups based on your risk for cancer recurrence. Depending on the group assigned, participants receive either standard dose of radiation therapy (RT), a moderately reduced dose of RT, or an extremely reduced dose of RT. During the RT treatment, participants will also receive chemotherapy. Chemotherapy will be given at the same dose used in routine care for everybody in the study. Participants will be in the study for up to 5 years.

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

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 Ulcerative Colitis

Date Added
May 17th, 2023
PRO Number
Pro00128120
Researcher
Erin Forster

List of Studies


Keywords
Ulcerative colitis
Summary

This is a randomized, double-blind, active- and placebo-controlled, parallel group, multicenter study to evaluate the efficacy and safety of induction and maintenance JNJ-78934804 therapy in participants 18 to 65 years of age (inclusive, at the time of consent), with moderately to severely active UC as determined by a modified Mayo score ≥5 and a final reported endoscopy subscore ≥2 obtained during the central review of the screening video endoscopy. Participants must also have demonstrated an inadequate initial response, loss of response, or intolerance to ≥1 approved ADT (advanced therapy inadequate responder [ADT-IR]). Overall, the study will evaluate 48 weeks of therapy with JNJ-7893480. The primary objective of the study is to evaluate the efficacy of JNJ-78934804 at Week 48
compared with each monotherapy (guselkumab alone and golimumab alone).

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

A Randomized Phase II Study Comparing Inotuzumab plus Chemotherapy versus Standard Chemotherapy in Older Adults with Philadelphia-Chromosome Negative B-Cell Acute Lymphoblastic Leukemia (ALL)

Date Added
May 18th, 2023
PRO Number
Pro00128781
Researcher
Alexander Coltoff

List of Studies

Keywords
Cancer, Cancer/Leukemia
Summary

This trial will enroll patients 50 years and older with acute lymphoblastic leukemia (ALL). Patients above age 50 years are not eligible for intensive chemotherapy regimens and have been shown to have worse outcomes than adolescents and young adults treated with the same chemotherapy. For instance, the 5-year survival for patients aged 55-65 years treated on an international ALL trial was 21% compared to 38% for younger patients. Similarly, the 5-year survival for patients treated at MD Anderson Cancer Center with the hyper-CVAD regimen was 30% for patients aged 40-59 years compared to 51% for those less then age 40 years.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
(843)792-9371
hcc-clinical-trials@musc.edu

A Phase 3, Multi-center, Randomized, Quadruple-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Batoclimab as Induction and Maintenance Therapy in Adult Participants with Generalized Myasthenia Gravis (gMG)

Date Added
May 23rd, 2023
PRO Number
Pro00128352
Researcher
Katherine Ruzhansky

List of Studies


Keywords
Autoimmune disease
Summary

The FLEX study is a randomized, blinded, and placebo-controlled study assessing the efficacy and safety of an investigational drug for adults diagnosed with Generalized Myasthenia Gravis (gGM). The injectable investigational drug is being evaluated over a 12-week induction period and a 12-week maintenance period. Based on completion of these periods and a participant's response to the investigational injection, participants may qualify to continue in a 52-week extension study of the investigational drug. If you choose to enter this study, you will participate in the study for up to approximately 84 weeks (1 ½ years) and you will be asked to attend up to 34 study visits; visits can last from 1 to 4 hours.

It is unknown at this time whether the study treatment will improve participant's health. The potential risks of this study include the possibility of infections, low albumin levels, and increases in blood cholesterol.

Institution
MUSC
Recruitment Contact
Della MacNicholas
843-792-8385
macnichd@musc.edu

The Rhythm Evaluation for Anticoagulation with Continuous Monitoring of Atrial Fibrillation

Date Added
May 23rd, 2023
PRO Number
Pro00128438
Researcher
Rachel Kaplan

List of Studies

Keywords
Cardiovascular
Summary

This research is being done to assess whether it is safe and effective to stop oral anticoagulation medications (a blood-thinning medication) during prolonged periods of normal heart rhythm in participants with infrequent episodes of atrial fibrillation (AF).

You may qualify for this study if you have a history of atrial fibrillation (AF) and are currently taking an oral anticoagulant (a blood-thinning medication). You will be randomized to one of two groups: Control Group or Study Intervention Group.

If you are randomized to the Control group, you will be asked to stay on your previously prescribed oral anticoagulant. If you are randomized to the Study Intervention group, you will be asked to take the oral anticoagulant for 30 days only if a prolonged episode of AF is detected on an AF-sensing Apple smartwatch you will be provided.

Institution
MUSC
Recruitment Contact
Kavin Panneerselvam
843-792-0464
panneeer@musc.edu

Multicenter Phase 3 Pivotal Study to Evaluate the Safety and Efficacy of TOOKAD (padeliporfin) Vascular Targeted Photodynamic Therapy in the Treatment of Low Grade Upper Tract Urothelial Cancer

Date Added
June 1st, 2023
PRO Number
Pro00118327
Researcher
Robert Grubb

List of Studies


Keywords
Cancer, Cancer/Genitourinary, Drug Studies, Men's Health, Women's Health
Summary

The study is for patients that have been diagnosed with low-grade non-invasive upper tract urothelial cancer. The investigational drug used in this study is padeliporfin which is injected into a vein. The main purpose of this study is to learn about the effects and safety of an investigational treatment named padeliporfin Vascular Targeted Photodynamic (VTP) Therapy, in treating low-grade non-invasive upper tract urothelial cancer. Participants can expect to be in this study for up to 18 months. The completion of the study will include up to 9 study visits to the study site and 8 phone visits.

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

A Multicentre, Randomised, Double-blind, Parallel Group, Placebo-controlled, Time-to-first Asthma Exacerbation Phase III Efficacy and Safety Study of Benralizumab in Paediatric Patients with Severe Eosinophilic Asthma (DOMINICA)

Date Added
June 6th, 2023
PRO Number
Pro00126684
Researcher
Kelli Williams

List of Studies


Keywords
Allergy, Asthma, Pediatrics
Summary

The main purpose of this study is to see if taking benralizumab is effective in treating Severe Eosinophilic Asthma in patients 6 to 17 years old compared with placebo. Benralizumab is administered through a subcutaneous injection (shot). Participation in the study is divided into two parts. The first part will last up to 16 weeks or until an asthma attack or flare is experienced. The second part will last up to two years.

Institution
MUSC
Recruitment Contact
Natalie Naylon
8437925824
naylon@musc.edu

POST-APPROVAL STUDY 2: HINTERMANN SERIES H3® TOTAL ANKLE REPLACEMENT SYSTEM

Date Added
June 12th, 2023
PRO Number
Pro00127864
Researcher
Christopher Gross

List of Studies


Keywords
Arthritis, Joint, Pain
Summary

Total ankle replacement has become an increasingly recommended treatment option for endstage ankle osteoarthritis over the last decades. As a result of this progress, a large variety of implant systems exist.

The Hintermann Series H3 Total Ankle Replacement System (H3) is a three-piece, mobile-bearing implant. The H3 is indicated for use as a non-cemented implant to replace a painful arthritic ankle joint due to primary osteoarthritis, post-traumatic osteoarthritis, or arthritis secondary to inflammatory disease.

The purpose of this study is to investigate long-term (up to 5 years) how the H3 implant is performing, collect information about the device through x-rays of the joint, document any complications from the device implant, see how the device affects patient quality of life.

Institution
MUSC
Recruitment Contact
Joshua Morningstar
843-792-1383
Morninjo@musc.edu

A randomized, double-blind, double-dummy, parallel group study, comparing the efficacy and safety of remibrutinib versus teriflunomide in participants with relapsing multiple sclerosis, followed by extended treatment with open-label remibrutinib

Date Added
June 13th, 2023
PRO Number
Pro00128476
Researcher
Andrew Keegan

List of Studies

Keywords
Multiple Sclerosis
Summary

The main purpose of the study is to find out if patients treated with remibrutinib may experience fewer Multiple Sclerosis relapses (also called clinical attacks, exacerbations or flare ups) than patients treated with teriflunomide (also known as Aubagio). Teriflunomide is an approved medication for the treatment of relapsing MS. This clinical study will have two parts. The first part is the masked part in which neither you nor your doctor know if you receive remibrutinib or teriflunomide and will last up for a maximum of up to 30 months (~2.5 years). This is followed by an Extension Part which will have treatment and safety follow up periods; during the treatment period remibrutinib treatment is provided to all participants who had completed core part of study for a maximum of up to 5 years.

Institution
MUSC
Recruitment Contact
Alison Line
Alison Line
line@musc.edu



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