IPX203 is an investigational extended-release (i.e. releases drug more slowly) capsule formulation of carbidopa-levodopa (CD-LD) administered orally (by mouth). "Investigational" means that IPX203 is being tested and has not been approved for marketing.
IPX203 is being investigated to determine whether the drug is safe and potentially has a better effect than currently approved IR CD-LD. If successful, the drug could possibly improve the daily control of motor symptoms in people with Parkinson's disease.
IPX203 is provided as a capsule containing 140 mg LD and 35 mg CD. The study doctor may adjust the IPX203 dosing regimen based on your response to the study drug during the 4 week dose conversion period. Your study doctor will instruct you on the dose of IPX203 or IPX203 placebo that you will receive during the 13-week portion of the study.
Your total participation time in the study will be approximately 24 weeks (6 months), which includes 4 weeks for your initial assessment (screening) period to determine if the trial is suitable for you.
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.
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.