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

A DOSE-BLINDED EXTENSION STUDY TO EVALUATE THE LONG-TERM EFFICACY, SAFETY, AND TOLERABILITY OF UCB0599 IN STUDY PARTICIPANTS WITH PARKINSONS DISEASE

Date Added
April 11th, 2023
PRO Number
Pro00126045
Researcher
Vanessa Hinson

List of Studies


Keywords
Parkinsons
Summary

This study is designed to provide further longer-term evidence and
understanding of the efficacy, safety, and tolerability of the study drug UCB0599 in slowing the progression of Parkinson's Disease only in study participants who have completed 18 months of treatment in PD0053 Study. This study requires previous participation in the PD0053 study. There are 11 visits spanning over 30 months. Main study activities include; electrocardiograms, vital sign assessments, physical exam, neurological exam, blood and urine collection, and UCB0599 administration and follow-up.

Institution
MUSC
Recruitment Contact
Lisa Heidelberg
843-792-9371
heidelbe@musc.edu

A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of BIIB122 in Participants with Parkinson's Disease

Date Added
March 28th, 2023
PRO Number
Pro00123124
Researcher
Christine Cooper

List of Studies


Keywords
Parkinsons
Summary

This study will help determine the safety and effectiveness of BIIB122, compared to placebo (an inactive substance), in people with early-stage Parkinson's disease. The use of BIIB122 in this study is investigational. "Investigational" means that the study drug is currently being tested and is not approved by the U.S. Food and Drug Administration (FDA) or any other health authorities around the world for treating people with PD. The study is expected to last a minimum of 1 year to a maximum of 3 years. You may or may not receive direct medical benefit from participating in this study. Your condition may get better, worse, or stay the same. The information obtained from this study, however, could help other patients with your disease in the future.

Institution
MUSC
Recruitment Contact
Sandra Wilson
8437924616
wilsosan@musc.edu

A Neural Basis for Cognitive Decline Following Deep Brain Stimulation

Date Added
January 25th, 2023
PRO Number
Pro00125181
Researcher
Daniel Lench

List of Studies

Keywords
Brain, Parkinsons
Summary

The objective of this research study is to identify brain biomarkers using MRI scans that can predict an individual's response to Deep Brain Stimulation (DBS). A total of 55 participants with Parkinson's Disease planning to undergo DBS will be recruited from MUSCs Clinical DBS Program. Participants will undergo two visits which include a 2.5-hour pre-DBS questionnaire and MRI scanning visit, and a 3.5-hour post-DBS cognitive assessment visit.

Institution
MUSC
Recruitment Contact
Daniel Lench
843-792-9115
lenchd@musc.edu

A 6-month prospective, randomized, double-blind, placebo-controlled clinical trial investigating the efficacy, safety, and tolerability of two different doses of buntanetap or placebo in patients with early Parkinson's disease

Date Added
January 24th, 2023
PRO Number
Pro00124325
Researcher
Vanessa Hinson

List of Studies


Keywords
Parkinsons
Summary

The study will be conducted in subjects with early Parkinson's Disease. Qualified subjects will be randomly assigned at a 1:1:1 ratio to one of the three treatment arms: buntanetap 10 mg, buntanetap 20 mg, and placebo. Randomization to one of these groups is like drawing numbers out of a hat. Buntanetap is an oral medication and has shown to improve mobility of people with Parkinson's Disease. Study duration will be about 7 months.

Institution
MUSC
Recruitment Contact
Christina Marsicano
8438769754
marsican@musc.edu

Non-Invasive Brainstem Modulation for the Treatment of Non-Motor Symptoms in Parkinson's Disease: A Randomized Control Trial (RCT) and an Open Label Extension Study (OLE).

Date Added
July 27th, 2021
PRO Number
Pro00111985
Researcher
Vanessa Hinson

List of Studies


Keywords
Parkinsons
Summary

This study will help to determine if using an investigational neuromodulation headset device will help treat non-motor symptoms associated with Parkinson's disease (PD). The effectiveness of neuromodulation will help oral dopamine replacement therapies to improve (1) activities of daily living related to motor function, (2) motor symptoms and (3) quality of life for patients with PD. The headset will be worn for a total of 40 minutes per day (two 20 minute intervals). The study will take place over a year and will require a study partner to participate. This is a randomized controlled trial that randomizes participants into an intervention group or a control group (placebo). Participants will not know which treatment they are receiving. Questions about quality of life such as; depression, anxiety, PD symptoms, will also be asked.

Institution
MUSC
Recruitment Contact
Lisa Heidelberg
843-792-8327
heidelbe@musc.edu

Combined Deep Brain Stimulation and Functional Magnetic Resonance Imaging

Date Added
July 20th, 2021
PRO Number
Pro00111668
Researcher
Gonzalo Revuelta

List of Studies


Keywords
Brain, Movement Disorders, Parkinsons
Summary

The purpose of this research study is to identify brain activation patterns in response to deep brain stimulation (DBS). To participate in this study, participants are required to have had a DBS implant or to be healthy controls without a history of a neurological disorder. Participants will undergo screening, a motor assessment session and a 30-minute Magnetic Resonance Imaging (MRI) session where their DBS device will be turned on and off in a cycled pattern. This study will be separated over 3 visits (Visit 1 for screening, Visit 2 for motor assessments and Visit 3 for the MRI scans). The total study duration will be approximately 5 hours.

Institution
MUSC
Recruitment Contact
Daniel Lench
843-792-9115
lenchd@musc.edu

Effect of Istradefylline (ISD) treatment on behavioral measures of apathy in Parkinson's disease (PD)

Date Added
May 25th, 2021
PRO Number
Pro00108116
Researcher
Travis Turner

List of Studies


Keywords
Parkinsons
Summary

Apathy is defined as a lack of feeling, emotion, interest, or concern. Apathy also involves reduction or loss of motivation and goal-directed behavior. Clinically significant apathy, where meaningful activities are given up and quality of life is diminished, is common in people with Parkinson's disease (PD).

Many individuals with Parkinson's disease experiencing fluctuations in the severity of their movement problems and medication "off" time. "Off" time refers to periods of the day between doses of PD medication when your motor symptoms (e.g., tremor, stiffness, slowness, walking problems, etc.) are worse and interfere with your ability to complete tasks of daily living. The investigational drug, Istradefylline, is an FDA-approved medication to treat motor fluctuations and "off" time in PD.

The purpose of this study is to investigate whether people with Parkinson's disease (PD) who are treated with istradefylline (ISD) show improvements in motivation and apathy over a 12-week period. Specifically, we wish to see whether people with PD who are treated with ISD engage in more physical and recreational activities, such as hobbies and other interests.

Institution
MUSC
Recruitment Contact
Sandra Wilson
843-792-0372
wilsosan@musc.edu

Using task based fMRI to examine neural networks underlying gait in participants with Parkinson's Disease and Stroke

Date Added
January 19th, 2021
PRO Number
Pro00104950
Researcher
Gonzalo Revuelta

List of Studies


Keywords
Healthy Volunteer Studies, Parkinsons
Summary

Parkinson's disease and stroke can cause lasting changes in walking and mobility. Non-invasive brain imaging methods including Magnetic Resonance Imaging (MRI) have been useful tools to understand the brains contribution to disrupted gait. In this study we are evaluating how activity in the brain in stroke and Parkinson participants changes when they are engaged in a gait-like behavior in the MRI scanner. We are seeking to recruit 10 participants with a diagnosis of PD, 10 participants with a history of stroke, and 10 age matched healthy control participants without a diagnosis of PD to undergo an hour of MRI scanning and an hour of gait assessments.

Institution
MUSC
Recruitment Contact
Sandra Wilson
2-4616
wilsosan@musc.edu

Clinical and laboratory studies to determine the causes of neurological disease in adults and children

Date Added
September 15th, 2020
PRO Number
Pro00102718
Researcher
Catherine Ziats

List of Studies

Keywords
Alzheimers, Autism, Dementia, Epilepsy, Mental Health, Multiple Sclerosis, Parkinsons
Summary

Neurological diseases are the leading cause of disability worldwide and a major contributor to health problems in children and adults. As the majority of these conditions result in lifelong disabilities, the implications for the family and for society is significant.

A significant number of adult and childhood neurological diseases have a genetic component and are caused by changes in our DNA and/or RNA leading to functional changes in the central nervous system. However, for many patients afflicted with these disorders, traditional genetic testing does not identify a clear genetic cause. The goal of this study will be to use newer genetic techniques to evaluate patients and families with neurological disorders to better understand the genetic basis of the disease.

Institution
Self Regional Healthcare
Recruitment Contact
Catherine Ziats
8642507944
cziats@ggc.org



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