AN OPEN-LABEL, MULTI-CENTER, FOLLOW-UP STUDY DESIGNED TO EVALUATE THE LONG-TERM EFFECTS OF AP-CD/LD IN FLUCTUATING PARKINSON'S DISEASE SUBJECTS WHO COMPLETED STUDY IN 11 004 Save

Date Added
October 23rd, 2018
PRO Number
Pro00081131
Researcher
Christine Cooper

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Keywords
Parkinsons
Summary

This study will allow evaluation of long-term safety and clinical effects as well as to allow patients to benefit from extended treatment duration with AP-CD/LD after they have successfully completed the Phase 3 core study IN 11 004 (?core study', a Phase III, multicenter, randomized, double-blind, double-dummy, active-controlled Phase III study to assess the safety and efficacy of AP-CD/LD versus IR CD/LD in fluctuating PD patients).

Institution
MUSC
Recruitment Contact
Danielle Helms
843-792-8327
helmsda@musc.edu

Odor Disturbances: Clinical Care Registry Save

Date Added
September 26th, 2018
PRO Number
Pro00080333
Researcher
Thomas Uhde

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Keywords
ADD/ADHD, Adolescents, Aging, Allergy, Alzheimers, Anxiety, Asthma, Autism, Autoimmune disease, Central Nervous System, Chronic Fatigue, Depression, Environmental Factors, Fibromyalgia, Inflammation, Memory Loss, Nervous System, Parkinsons, Psychiatry
Summary

Candidates for this study may or may not report disturbances in odor perception as their primary reason for seeking treatment at MUSC. This study is designed to collect long term, observational data from patients who are being treated with routine clinical care in health clinics at MUSC. Data from clinical questionnaires will be de-identified and stored in a database.

Institution
MUSC
Recruitment Contact
Richard Simmons
843-792-7439
simmr@musc.edu

Direct measurement of motor cortical responses to transcranial direct current stimulation Save

Date Added
May 15th, 2018
PRO Number
Pro00073545
Researcher
Nathan Rowland

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Keywords
Brain, Central Nervous System, Movement Disorders, Muscle, Nerve, Nervous System, Parkinsons, Surgery
Summary

Transcranial direct current stimulation (tDCS) has shown the potential to improve symptoms in patients with Parkinson's disease, however its effects have not been consistent in randomized studies to date, limiting widespread adoption of this technology. A critical gap in our knowledge is a detailed understanding of how tDCS affects motor areas in the brain. We propose using tDCS while recording directly from motor cortex using subdural electrocorticography (sECoG) in Parkinson's patients undergoing deep brain stimulation surgery. We expect this novel approach to broaden our understanding of tDCS application in Parkinson's disease and possibly lead to therapeutic advances in this population.

Institution
MUSC
Recruitment Contact
Sanicqua Robinson Smalls
843-792-8553
robinsst@musc.edu

A Multicenter, Randomized, Double-Blind, Placebo- Controlled Study of the Safety, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Subjects with Parkinson's Disease Save

Date Added
April 24th, 2018
PRO Number
Pro00075276
Researcher
Vanessa Hinson

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Keywords
Parkinsons
Summary

The purpose of this study is to evaluate the safety of BIIB054 at several different doses. This study will also look at how BIIB054 affects your body (Pharmacodynamics) and how your body affects BIIB054 (Pharmacokinetics). It will also investigate how your immune system responds to BIIB054.

BIIB054 is an investigational product under development for the treatment of Parkinson's Disease. BIIB054 is an antibody, similar to proteins your body makes to try to rid itself of bacteria, viruses and certain other harmful agents. It is believed to work by attaching to molecules in your brain associated with Parkinson's Disease, called alpha-synuclein, and preventing them from causing damage.

To see how well the study drug works, it will be compared to a placebo in the study. A placebo is just like the study drug but it does not have any active ingredient. This is the best way for testing a new medicine in a research study because it keeps the study results from being influenced by what the research team thinks or hopes the new medicine might do.

BIIB054 or placebo will be administered by trained staff at the study center as an intravenous (IV) infusion, meaning that it will be given into one of your veins at a controlled rate. The duration of the infusion will be about 1 hour.

This study will be about 65 weeks. It includes a 5-week Screening period, a 48-week Treatment period, and a 12-week Follow?up period.

Subjects will take part in 1 screening visit and 13 dosing visits.

Institution
MUSC
Recruitment Contact
Danielle Helms
843-792-8327
helmsda@musc.edu

Transcutaneous auricular Vagal Nerve Stimulation (taVNS) in mild to moderate Parkinson's Disease Save

Date Added
March 20th, 2018
PRO Number
Pro00073767
Researcher
Vanessa Hinson

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Keywords
Parkinsons
Summary

An investigator initiated pilot study of transcutaneous auricular vagal nerve stimulation (taVNS) in mild to moderate Parkinson's disease (PD).

We will assess whether nerve stimulation done on the surface of the skin, (called transcutaneous vagus nerve stimulation (taVNS)) is safe and effective in people with Parkinson's Disease (PD). A small electrical stimulator will be used to deliver electric pulses to a small portion of the left ear of the study participants. Participants will be assigned by chance to either 2 weeks of treatment with real taVNS, or a sham stimulation. The investigator will rate PD motor and cognitive symptoms before, during, and after the 2-week cycle. The investigators will also perform a number of blood and eye movement tests to check for the effectiveness of the stimulation, and perform regular safety checks.

Institution
MUSC
Recruitment Contact
Danielle Helms
843-792-8327
helmsda@musc.edu

A Randomized, Double-Blind, Placebo-Controlled, Phase IIa, Parallel Group, Two-Cohort Study to Define the Safety, Tolerability, Clinical and Exploratory Biological Activity of the Chronic Administration of Nilotinib in Participants with Parkinson's Disease (PD) Save

Date Added
December 19th, 2017
PRO Number
Pro00069638
Researcher
Vanessa Hinson

Silhouette
Keywords
Drug Studies, Movement Disorders, Parkinsons
Summary

The purpose of this study is to determine if a drug called Nilotinib is safe, if it can be tolerated by patients with PD and to learn if Nilotinib has the possibility of effectively treating PD symptoms. Nilotinib has been approved by the Food and Drug Administration (FDA) to treat certain types of cancer (leukemia) but is considered investigational in this study because it has not been approved for treating PD.

In this study, we are comparing two doses (150mg or 300mg) of Nilotinib to placebo (a pill that looks like the study drug but does not have any active medication in it, like a sugar pill). If you are eligible and choose to be in the study you will be randomly assigned to one of three groups, either:

? 150mg Nilotinib
or
? 300mg Nilotinib
or
? Placebo

All three groups will take two pills of the assigned type each day by mouth. ?Randomly' means that the group you are placed in is determined by chance (like tossing a coin). You will have a 2:1 chance of receiving Nilotinib. Neither you nor the researchers will know whether you are taking Nilotinib or placebo.

About 100 individuals will be interviewed and assessed, and 75 people will be asked to participate in this study at 25 clinics across the United States. Approximately 6 participants will be asked to participate in the study at MUSC.

Institution
MUSC
Recruitment Contact
Shonna Jenkins
843-792-9115
jenkisho@musc.edu

A Phase III, Multicenter, Randomized, Double-Blind, Double-Dummy, Active-Controlled Study Comparing the Efficacy and Safety of Gastric Retentive, Controlled Release Accordion Pill™ Carbidopa/Levodopa (AP-CD/LD) to Immediate Release CD/LD in Fluctuating Parkinson's Disease Patients Save

Date Added
November 28th, 2017
PRO Number
Pro00073013
Researcher
Christine Cooper

Silhouette
Keywords
Parkinsons
Summary

This study will assess the effectiveness, safety and tolerability of Accordion Pill™ Carbidopa/Levodopa (AP-CD/LD) compared to Immediate Release Carbidopa/Levodopa (IR CD/LD) (Sinemet) in patients with fluctuating Parkinson's disease (PD).

Institution
MUSC
Recruitment Contact
Danielle Helms
843-792-8327
helmsda@musc.edu

Validation of computer-based saccade and pupillary light reflex measures as biomarkers for progressive supranuclear palsy Save

Date Added
July 18th, 2017
PRO Number
Pro00065862
Researcher
Marian Dale

Silhouette
Keywords
Aging, Brain, Movement Disorders, Nervous System, Parkinsons, Rare Diseases, Vision/ Eye
Summary

This study examines eye movements and the pupil's response to light in progressive supranuclear palsy (PSP), comparing to Parkinson's disease and control subjects without neurological disease. Computerized measures of eye movements and pupil changes will be used. Subjects will also receive an eye exam to rule out other eye diseases. The goal of this study is to use subtle changes in eye movements and the pupil's response to light for earlier diagnosis of PSP.

Institution
MUSC
Recruitment Contact
Shonna Jenkins
843-792-9115
jenkisho@musc.edu

Brain Circuitry Changes in Vascular Parkinsonism Save

Date Added
July 6th, 2017
PRO Number
Pro00063429
Researcher
Christine Cooper

Silhouette
Keywords
Parkinsons, Vascular
Summary

This study will examine changes in brain architecture that are associated with vascular parkinsonism, in comparison to Parkinson's disease. We will do this by using advanced imaging techniques to compare brain structure between subjects with vascular parkinsonism and Parkinson's disease.

Institution
MUSC
Recruitment Contact
Nancy Feracco
843-792-7859
feracco@musc.edu

Dopamine agonists in the treatment of Parkinson's disease-associated depression: a naturalistic study Save

Date Added
March 28th, 2016
PRO Number
Pro00049718
Researcher
Fredy Revilla
Keywords
Parkinsons
Summary

This is a prospective, observational, naturalistic study to assess the efficacy of dopaminergic medications in reducing depressive symptoms, as measured by validated self-rating depression scales, and compared to initiation of alternative dopaminergic therapies (e.g. L-dopa vs. DA vs. MAO-B inhibitors).

Ascertainment of a true antidepressant effect of Pramipexole, Rotigotine and/or Ropirinole (or of any of the other dopaminergic agents) would have an impact on the manner in which this disabling problem is currently addressed.

In this study, we seek to collect data on the putative antidepressant and anti-apathy effect of dopaminergic medications (L-dopa and non-ergot DA, RPN, PPX, and rotigotine [RTG]), given under naturalistic conditions to address motor impairment (not mood disorders), on PD patients, as measured by validated depression and apathy rating scales, and comparing it to changes to L-dopa and other anti-parkinsonian agents.

Institution
Greenville
Recruitment Contact
Enrique Urrea Mendoza
864-454-5076
eurreamendoza@ghs.org

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