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OCD Study (SEEG-Guided DBS for OCD)
Funding provided by: University of Pennsylvania (internal funding)
Study timeline: 4/1/2023-3/31/2027
Investigator: Casey H. Halpern, MD, Director of Stereotactic and Functional Neurosurgery, UPenn
The SEEG-Guided DBS for OCD is a dual-site, double-blinded, randomized, sham-controlled, crossover study that will assess the safety, feasibility, and preliminary efficacy of SEEG-guided multi-lead DBS in 10 participants suffering from severe symptoms of chronic, treatment-refractory OCD. The goal of this study is to address the unmet need of treating severe, treatment-refractory OCD by identifying brain networks underlying the disorder and optimal stimulation targets that can therapeutically engage these networks to relieve symptoms. The study began recruitment in March 2024. The study will follow 10 patients over three years at different stages of deep brain stimulation. There will be two sites participating in the study, University of Pennsylvania and Stanford University with the PI’s being Casey Halpern, MD, and Nolan Williams, MD respectively.
The Clinical Research Collaboration Unit (CRCU) provides project management, data management and research technology services to support this project. Please note that this study is FDA regulated and required to follow 21 CFR Part 11 compliance.
GBS Study
Funding provided by: Argenx
Study timeline: 4/4/2023-4/3/2026
Investigator: Chafic Karam, MD,Neuromuscular Fellowship Director, University of Pennsylvania
PENN-GBS-ESR is a phase 2, randomized, double-blind clinical trial to assess efficacy and safety of Efgartigimod in GBS. The hypothesis is that Efgartigimod is effective and safe in GBS patients. Patients will be randomized to get the standard-of-care IVIG or the investigational product Efgartigimod by randomization tables. IVIG is the standard of care treatment for GBS and is the most widely used treatment for this disorder. Efgartigimod, works in a similar fashion to IVIG but is in vitro more effective and has a more rapid onset of action. The study will be a pilot to determine whether a larger study is warranted. The Clinical Research Collaboration Unit (CRCU) provides project management, data management and research technology services to support this project. Please note that this study is FDA regulated and required to follow 21 CFR Part 11 compliance.
ATRA Study (All-Trans Retinoic Acid)
Funding provided by: A grant from Incyte
Study timeline: 8/15/2022-7/31/2026
Investigator: Stephen J. Bagley, MD, MSCE, Division of Hematology/Oncology
ATRA is a single-center, open label study evaluating the efficacy and safety of the combination of all-trans retinoic acid (ATRA) and retifanlimab for patients with recurrent IDH-mutant glioma. The study has a Safety Run-In Portion, a Phase 2 Portion, and a Surgical Portion. The Phase 2 portion and Surgical portion will open to enrollment simultaneously following successful completion of the Safety Run-In. This is a single center study and subjects are only recruited from the University of Pennsylvania. Recruitment for Phase 2 ends when 6 evaluable subjects have been enrolled in the Safety Run-In phase and 33 evaluable subjects have been enrolled in Phase 2. Recruitment for the Surgical Portion ends when 16 evaluable subjects have been enrolled in this portion of the protocol. The Clinical Research Collaboration Unit (CRCU) provides project management, data management and research technology services to support this project. Please note that this study is FDA regulated and required to follow 21 CFR Part 11 compliance.