This randomized clinical trial is designed to test the efficacy of ZA-5 mg in PD patients. This trial will also address barriers to treatment of patients with PD by providing rigorous evidence about whether ZA reduces fracture risk in patients with PD, simplifying treatment by giving ZA at home without extra medical visits and BMD testing, and overcoming poor persistence with oral therapies because one infusion may prevent bone loss for at least 2 years. The outcome of this trial will demonstrate how a home-based fracture prevention can reach older PD patients who would not otherwise receive treatment to reduce their high risk of fractures.
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.
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.
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.