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Jacobson Center for Clinical & Translational Research

Studies at ¹û¶³´«Ã½: Neurology

Epilepsy

Study Title: ÌýA Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Cenobamate Adjunctive Therapy in Subjects with Primary Generalized Tonic-Clonic Seizures

Identifier:Ìý

Study Purpose:ÌýThe purpose of this study is to evaluate the clinical efficacy and safety of cenobamate adjunctive therapy in PGTC seizures.

Principal Investigator: Naeem Mahfooz, MD

Study Coordinator:Joyeta Razzaque, MD, 419.383.4553

Huntington's Disease

Study Title: ÌýDIMENSION 718-CIH-201 A Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Effect of SAGE-718 on Cognitive Function in Participants with Huntington's Disease

Identifier:Ìý

Study Purpose: The primary purpose of this study is to evaluate the tolerability and effectiveness of SAGE-718 on cognitive performance in study subjects with HD. ÌýÌýThe study will also evaluate the safety of SAGE-718, the effect on neuropsychiatric symptoms, and overall health-related quality of life.

Principal Investigator: Lawrence W. Elmer, MD, PhDÌý

Study Coordinator:Nancy Vollmar, RN, 419.383.4573

Parkinson's

Study Title:ÌýÌýA Randomized, Double-Blind, Placebo-Controlled, Two-Part Study in Parkinson's Disease Patients with Dyskinesia to Asses the Efficacy and Safety/Tolerability of Fixed Dose Combinations of JM-010 and its Individual Components

Identifier:Ìý

Study Purpose:ÌýThe purpose of this study is to assess the efficacy and safety/toelerability of fixed dose combinations of JM-010 and its individual components.

Principal Investigator: Thyagarajan Subramanian, MD

Study Coordinator:Joyeta Razzaque, MD, 419.383.4553

Study Title:ÌýÌýA Multi-center, Noninterventional Study Evaluating Variability, Reliability and compliance for the Parkinson's Disease Diary.

Identifier:Ìý

Study Purpose:ÌýThe purpose of this study is to evaluate the variability, reliability, and compliance for the PD Diary.

Principal Investigator: Thyagarajan Subramanian, MD

Study Coordinator:Joyeta Razzaque, MD, 419.383.4553

Study Title:ÌýÌýFunctional MRI Assessment of the Mental Rotation Task in Early Onset Parkinson's Disease Patients.

Identifier: Investigator initiated.

Study Purpose: Investigator initiated.

Principal Investigator: Thyagarajan Subramanian, MD

Study Coordinator:Joyeta Razzaque, MD, 419.383.4553

Study Title:ÌýÌýNeuropsychological Tests to Assess Cognitive Differences in Early Onset Parkinson's Disease (EOPD) Patients.

Identifier:ÌýInvestigator initiated.

Study Purpose: Investigator initiated.

Principal Investigator: Thyagarajan Subramanian, MD

Study Coordinator:Joyeta Razzaque, MD, 419.383.4553

Study Title: ACTIVATE A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of BIA 28-6156 in Subjects with Parkinson’s Disease With a Pathogenic Variant in the Glucocerebrosidase (GBA1) Gene

Identifier:Ìý

Study Purpose: The primary purpose of this study is to investigate the effects, safety, and tolerability of BIAÌý28‑6156.Ìý This study is also meant to find out if the effects, safety, and tolerability are different in people with different forms of the GBA1 gene, which is a genetic characteristic that may be related to a higher risk of getting Parkinson’s disease, and if BIAÌý28-6156 can slow down the worsening of the disease.

Principal Investigator: Lawrence W. Elmer, MD, PhD

Study Coordinator:Stephanie Wilson, MSN, APRN, CCRC, 419.383.6721

Study Title: ATLANTIS A Multicenter Phase 2, Double-Blind, Placebo-Controlled, Randomized, Parallel-Group Study To Evaluate The Efficacy, Safety, Tolerability, And Pharmacokinetics Of UCB0022 In Study Participants With Advanced Parkinson’s Disease.

Identifier:Ìý

Study Purpose: The primary purpose of this study is to demonstrate the superiority of UCB0022 as an adjunctive treatment to a stable dose of concomitant PD medication (including at least levodopa therapy) over placebo with regard to motor fluctuations time spent in the OFF state (OFF time) in study participants with advanced PD.

Principal Investigator: Lawrence W. Elmer, MD, PhD

Study Coordinator:Stephanie Wilson, MSN, APRN, CCRC, 419.383.6721