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

A double-blind, placebo-controlled, randomized, 18 month Phase 2a study to evaluate the efficacy, safety, tolerability, and pharmacokinetics of oral UCB0599 in study participants with early Parkinson's Disease

Date Added
June 8th, 2021
PRO Number
Pro00109171
Researcher
Vanessa Hinson

List of Studies


Keywords
Parkinsons
Summary

This study will help to determine if UCB0599 (study drug) can slow the progression of Parkinson's Disease (PD.) The study will look to demonstrate the superiority of UCB0599 over placebo with regard to clinical symptoms of disease progression over 12 and 18 months in participants diagnosed with early-stage PD.
Study participation will take place over 19 months (16 Visits) and will consist of in-clinic and remote visits. Participants will take UCB0599 orally, in pill form.

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



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