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

Date Added
March 3rd, 2022
PRO Number
Pro00116394
Researcher
Federico Rodriguez-Porcel

List of Studies


Keywords
Movement Disorders
Summary

This study will test SAGE-718 to evaluate cognitive effects in subject with early manifest HD. The subject will be on study drug or placebo for 84 days. 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

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

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

Date Added
November 14th, 2023
PRO Number
Pro00127605
Researcher
Federico Rodriguez-Porcel

List of Studies


Keywords
Parkinsons
Summary

The purpose of this clinical trial is to evaluate the safety and efficacy of BIA-28-6156 in subjects with Parkinson's Disease (PD). BIA -28-6156 is an investigational drug meaning that its safety, effects and how it works are still being studied. This is a randomized (assigned by chance), placebo-controlled study, which means that some participants will receive a fake treatment (placebo) while others get the real treatment. The placebo treatment looks like the BIA-28-6156 medications but doesn't contain any active ingredient. The medication is in a pill form and will be administered orally. This research is also double blind, meaning that neither the participants nor the researcher will know which treatment they will be receiving. In Part A of this study, participants will be asked to give a blood sample for a genetic screening test. If genetic testing in part A indicates the person can participate, they may be asked to volunteer for part B. Duration of Part B is about 87 weeks, this includes 5 weeks for screening, 78 weeks for the double-blind treatment period, and 4 weeks for follow up. There are at least 11 visits in total in 20 months (9 clinic visits, 2 remote phone/video visits); this does not include unscheduled visits. During visits, participants should anticipate tests including electrocardiograms (ECGs), vitals measurements (including temperature, blood pressure, and heart rate), and a physical/neurological examination. Some of the risks includes fatigue, headache, drowsiness, muscle aches and possible worsening of PD symptoms. As for benefits, participants who receives the BIA drug may see their PD progression slowing.

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



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